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ResMed jobs

ResMed
17Jan
Engineering Assistant
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Location: Singapore – Loyang Crescent and Tuas

Let’s talk about the team and you:

We are seeking for experienced Engineering Assistant to support production in a high volume manufacturing environment based at Loyang office.

ResMed is a global leader in the design, manufacture and distribution of innovative products for the diagnosis, treatment and management of respiratory disorders. The company has experienced sustained and significant growth since inception. One of the principal contributors to this growth is innovation reflected in a commitment to producing world-class product lines. The global competitive environment is becoming more difficult which is resulting in a greater emphasis on innovation and a cost effective approach to achieving market leadership through technological advances.

Let's talk about responsibilities:

Technical assistance for assembly level operators to fix production jig, fixture, equipment and layout.Assist production with 5S and OH & S improvements.Identify and implement continuous improvement opportunities

Assist engineers to test new hardware/software prior to production implementation.

Execution of validation protocol.Assist in the routing of documentation for approval

To install, qualify, calibrate, maintain & document manufacturing test equipment/systems as required for production line.

Liaise with external calibrator and/or maintenance provider, for test fixture or equipment that requires external calibration and/or maintenance.

Registration of new fixture or equipment into Calman Manager.

Assemble new test fixtures or systems.

Liaise with vendor on jig, fixture & equipment modification.

Production Label printer support

Perform other tasks as requested to assist the business reach and maintain its goal.

Let's talk about qualifications and experience:

Understands the manufacturing and test processes and uses logical and analytical thinking to resolve issues

Experience in Electrical, Electronic, Pneumatic and Mechanical devices and systems

Ensuring minimal downtime on manufacturing lines, this may necessitate working flexible hours Document Test outcomes clearly and succinctly

Ensures compliance with Quality & safety Standards

Stay on top of changes

Ability to work independently

Good analytical skills

Basic Soldering skillsTechnical Report writing skills

Applicant with robotics and automation experience will be an added advantage

Applicant must be willing to commit 12-hours shift work pattern (Day or Night Shift):Work hours: Permanent 12 hours night shift (7.30pm to 7.30am) Shift pattern: 2332 pattern (2 days work, 3 days off, 3 days work, 2 days off) Monday to Sunday

Minimum:

Institute of Technical Education with minimum 2 years’ experiences.Graduates in Mechanical/Mechatronic/Electronics Engineering Diploma, Electronics Certificate or equivalent with minimum 1 year experience.

Preferred:

Experience in supporting volume manufacturingExperience in Medical Device manufacturing industry

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
16Jan
Head Of Finance - Asia Growth Markets
ResMed   via Glassdoor

The Finance team’s goal is to be a trusted and collaborative partner to all the businesses and functional teams that we work with, bringing business acumen, financial expertise and insights to aid decision-making and deliver value to our stakeholders. We strive to generate value through providing specialist advice and making recommendations to optimize decision making, delivering transparent processes and implementing governance and controls to mitigate risk.

Head of Finance    Read more

– Asia Growth Markets

Singapore – Wework Funan

Let’s talk about the team and you

ResMed is a global leader of innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our cloud-connected medical devices transform care for people with sleep apnea, COPD, and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems in more than 120 countries

.

The company has experienced sustained and significant growth since inception.

ResMed’s Asia Growth Markets (AGM) business, a key driver of future growth, delivers revenue from the dynamic markets of China, India, ANZ, South Korea, and other Emerging Asian Markets. We are currently seeking applications from experienced finance partners to be a key member of the Asia Growth Markets (AGM) Leadership Team, working to unlock the massive potential of these markets through entrepreneurial channel development and exploration. You will be based in Singapore and report to the Global Head, FP&A based in the US.

You will be a key contributor to the extended global finance leadership team, helping to drive the futurization of the function. As a result, travel across these markets and global centres is required in order to develop the proper business relationships and market understanding, as well as build the trust needed to drive or influence change. With responsibility for a distributed team of Finance professionals you will be a leader who can demonstrate effective multi-geographic leadership and people development.

You will provide support in the areas of financial planning, reporting and analysis, as well as being a trusted advisor in shaping the strategy of the Asia Growth Market Region.

Let's talk about Responsibilities:

As the finance business partner, you will work with the President of AGM to provide strategic finance and business support to the AGM leadership team, and lead the finance team to:

Support innovative business models that drive competitive advantage for ResMed in complex and heterogeneous markets that form AGM

Lead planning and reporting processes that include long term financial plans, budgets & forecasts, and monthly and quarterly reporting

Support acquisitions, partnerships and ventures in AGM

Identify and drive operational effectiveness in all markets.

Support opportunities to optimize business models and improve financial metrics and create P&L leverage

Advise and educate, to build the overall financial and business acumen of the AGM team

Support statutory reporting and transactional processes, as required

Let’s talk Qualifications and Experience:

15 years of Finance and Accounting experience in global organizations

MBA / ACA / CPA qualified, experience with US GAAP

Excellent verbal and written English skills

Proficiency in Mandarin is preferred as he/she will manage the stakeholders and business alliances from China.

Business Partnering experience with Senior Management, influencing strategic decisions, commercial strategy and operating results. A demonstrated ability to influence within the business and across the enterprise.

Excellent relationship builder, high influencing and negotiation skills.

Excellent analytical, decision-making, project management and financial modelling skills.

Experience in managing cross functional global teams, with excellent organization skills.

Strong working knowledge of financial reporting and controls and compliance

Experience with ERP, EPM and Business Intelligence systems, ie: Oracle, Cognos, TM1, Anaplan, a plus.

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
13Jan
Senior Engineer – Xft Manufacturing Project Lead
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let’s talk about the team and you

The Manufacturing Engineering cross-functional team (XFT) function is located in both Sydney and Singapore Manufacturing Innovation Hubs. The team is the focal point in providing a great Manufacturing experience to Mask PD projects by representing Manufacturing Engineering on new project cross-functional teams. The team is accountable for end-to-end Manufacturing Engineering to ensure that new products, equipment and processes are delivered into production on time, and are developed to achieve best in class quality, cost & efficiency.

We are currently seeking applications from

Senior Engineer – XFT Manufacturing Project Lead

to join our Manufacturing Engineering team and is based in Singapore. The Senior Engineer plays a crucial role in Mask product conceptualisation and commercialisation. You will foster an effective collaboration and excellent partnership with engineering team, operations and product development to drive project delivery, NPI launches and ensure smooth transitions to product focus team and align with ResMed strategies.

Let's talk about responsibilities

The Project Lead spearhead the Manufacturing XFT function to ensure the right focus on technology development and risk management whilst staying abreast of issues within Operations that may affect delivery of the project.

Identify, develop, and implement new processes, equipment and technologies into production to meet current and future project requirements for volume, cost and quality.

Ensure that regular DFM/DFA reviews are conducted in conjunction with PD to ensure accountability for robust design.

Regularly report project progress to the Product Development and Manufacturing Management.

An output from this Manufacturing team will be a holistic view of manufacturing technology readiness, progress, risks and issues, which can be presented into the Project XFT, reported on at QAISR, or to represent Manufacturing at Phase Transitions

Engage the Manufacturing XFT and influence broader engineering teams to support new-product introduction by resolving technical issues in production as required.

Directly represent Manufacturing on Mask PD Project XFTs as the ‘Manufacturing XFT Representative’ particularly on early phase or larger more complex projects.

Engage both external and internal suppliers in understanding project risk, developing contingencies, tracking milestones and delivering robust project outcomes on time.

Ensure early engagement of the Precision Tooling, Performance Moulding NPI, PFT and SDE teams to ensure robust process development.

Interface with other project stakeholders to ensure that overall project objectives are achieved.

Identify & implement GMP, Six-Sigma LEAN improvement actions and ensure future manufacturing methods and materials will align with these principles.

Impact and influence within the team, either as a developing domain specialist or as a generalist/problem solver and lead efforts in coordinating and drive to completion; and be able to solve complex problems autonomously.

Let’s talk Qualifications and Experience:

6 to 8 years’ solid experience in New Product Development/NPI, engineering and project management functions within a high-volume manufacturing environment

Degree in Mechanical Engineering, Mechatronics Engineering, or equivalent.

Experience in the complete development lifecycle, including at least one project of significant technology or business impact.

Proficiency in Microsoft Office Suite

Excellent verbal and written English skills

Excellent problem-solving, analytical, coordination and project management skills

Experience in managing cross functional global teams, with excellent organization skills.

Ability to rapidly retain and utilise technical details and concepts

Ability to work under pressure, prioritise and work remotely as some team members are based in Sydney

Preferably with formal training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
13Jan
Software Engineer, Automation & Instrumentation
ResMed   via Glassdoor

The Respiratory Care team is transforming the way in which Chronic Obstructive Pulmonary Disease (COPD) care is managed and delivered though our non-invasive ventilation and portable oxygen solutions. This means we identifying the pain points for patients, providers and payers and developing deeper insights into the unmet needs of COPD patients. We see a future in which resources and technology are less focused on the diagnosis and treatment    Read more

of the disease and more oriented to prevention of COPD exacerbations and the slowing of disease progression.

The

Software Engineer (Automation & Instrumentation)

works within our product development team and will operate cross functionally, utilising best practices to provide products that will meet requirements for the global market. You will perform software engineering activities necessary to develop Respiratory Care products from concept to production. You will build software-based automated test systems to characterize various performance parameters of a product, technology or sub-assembly. This is part of an Agile development team and works with the team to analyze requirements and develop automated monitoring, analysis and test control strategies.

Let's talk about Responsibilities:

All aspects of software applications/tools development including requirements analysis, strategy development, coding and testing, visual demonstration and deployment

Applications/tools development within an Agile development environment including troubleshooting, data analyses, exploratory and design of experiments and other test areas.

Completeness and correctness of software and supporting subsystem deliverables, such as review of features and capabilities, automation efficiency review, requirements traceability and etcetera.

Regularly communication and progress updates with management and team members.

Let’s talk Qualifications and Experience:

Relevant Engineering or Science degree such as Software, Computer Science, Electronics, Mechatronics or equivalent.

At least 5 years of hands-on Experience developing Supervisory Control and Data Acquisition (SCADA) systems or similar applications.

Must have prior experience with application development using C# and .Net

Must have prior experience with data analysis using Matlab, Python, Labview or R

Preferred Experience with or in:

HIL (Hardware-In-Loop) simulation

automated testing technologies

big data analysis, storage and management

sensors, valves, compressors, motors or other software-controlled electromechanical systems

using an Agile development process

product development environment

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
10Jan
Graduate V&V Engineer
ResMed   via Glassdoor

The Sleep team is helping to fuel ResMed’s growth by focusing on solutions (products + software + services) to improve the quality of life for patients with sleep-disordered breathing and help providers improve efficiencies and reduce their costs. We are pioneers in providing a better experience for patients on therapy, and helping them achieve and maintain adherence with innovative masks and sleep devices with cloud connectivity. With nearly    Read more

a billion people estimated to be suffering from obstructive sleep apnea, this is an opportunity to make a difference and change people’s lives whether in Marketing, Sales, or product development.

The V&V Department is responsible for System Verification and Validation across all Business Units. It is also responsible for designing and automating (where possible) effective test methodologies. The Engineer role will work predominantly within a cross-functional project team to determine the scope, develop the strategy, plan, perform and document system level verification and validation activities for ResMed products, in accordance with Regulatory and Quality System Requirements.

Let's talk about responsibilities and accountabilities:

Work with Product Development teams in the early phases of development planning and performing Exploratory testing

Achieve project deliverables and milestones

Determine and document the scope and strategy of system verification and validation and document it in V&V plans

Develop protocols that effectively test the design requirements and sufficiently challenge the product design and, architecture

Perform testing and data analysis

Review and challenge system requirements for scope, risk and suitability

Initiate and drive requirements on automation and test instrumentation

Identify and investigate root cause of test anomalies and failures.

Raise and highlight design issues found during verification

Contribute to team growth

Provide technical guidance/support to student/graduate engineers

Collaborate with others to resolve issues effectively

Maintain technical skills and awareness of technical innovations

Communicate effectively with peers, stakeholders and supervisors routinely.

Let's talk about qualifications and experience:

Bachelor of Engineering in Mechatronics, Electrical, Biomedical, Mechanical, Chemical, Software, Systems or Computer Science – Engineering. Bachelor of Science – Physics is also acceptable.

Some experience in Product Development / R&D within a Quality Assured environment

Biomedical Engineering experience

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
09Jan
Test Engineer
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let's Talk About Responsibilities

We are currently seeking applications for a

Test Engineer

to join our Operations Team, this position will be

based in Loyang Crescent and relocate to Tuas new site in 2020.

You are part of the Test Engineering group in ResMed and play an important role for the design, implementation, deployment and maintenance of Test Systems used to test and calibrate ResMed product. You will be reporting to Manager, Manufacturing Engineering, based in Singapore.

Responsibilities:

Design, develop and qualify production test systems

to support product manufacture, ensuring new products meet specifications.

Develop hardware and software requirements

for suppliers (internal and external) involved in the design and fabrication of production test systems

Provide support and planning strategies

for the integration of software and hardware solutions required for the deployment of production test systems.

Maintain existing production test systems.

To provide

documentation

in accordance with the ResMed quality management system and support audit processes as required

To support

new product knowledge exchange

between product development and production teams

Familiarity with

GMP, Six-Sigma LEAN

improvement actions.

Let’s talk Qualifications and Experience:

To really get us excited, you will have a Tertiary qualification in

mechanical or electrical engineering

or related discipline with

at least 5 years industrial experience

with pneumatic, electronic testings, volume manufacturing, and bringing new designs into production, process validation within a highly regulated environment.

Experience with the development of production test systems

Working knowledge of analogue and digital electronic circuit design & analysis

Extensive knowledge of manufacturing processes and equipment

Excellent communication and documentation skills, including technical reporting

#LC-LC3

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
09Jan
Manufacturing Engineer (Npi) - Poc
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let’s talk about the team and you:

We are currently seeking applications for a Manufacturing Engineer (NPI) - POC to join our Operations Team, this position will initially be based in Loyang and relocate to Tuas new site in 2020. This role will contribute to our vision and to make our products better, more comfortable and more appealing for our patients around the world.

Let's talk about responsibilities:

Represent manufacturing for respective product focus team on new design project cross functionally, actively provide constructive technical feedback and recommendations to ensure robust, manufacturable product.

Engage external supplier as appropriate.

Understand project risk, develop contingencies, track milestones and deliver project outcomes on time.Implement manufacturing processes, equipment, facilities and documents to meet current and future production volume and delivery requirements.Introduce & maintain production procedures.

Provide training on new equipment, processes & procedures as required.

Complete process validation activities & documentation.

Identify & implement GMP, Six-Sigma LEAN improvement actions.

Assess and implement new processes, equipment and technologies for longer-term manufacturing requirement

Promote a safe working environment by following OH&S guidelines as well as implementing & closing out actions for the continual improvement of work place safety.

Let's talk about qualifications and experience:

Knowledge of manufacturing processes & equipment automation for high volume production of discrete products

Experience in Design for Assembly and PFMEA Process validation skills.

Excellent communication and documentation skills, including technical reports.

Working with competing priorities of the continues improvement of manufacturing processes and the achievement of early new product launch, within a strict regulated Quality System environment

Minimum:

Mechanical aptitude with Tertiary qualifications in engineering or related discipline

Along with 2 years relevant in process development, NPI and manufacturing

Preferred:

Experience in final product assembly manufacturing.

Experience in bringing new designs into production.

Experience in line design, process balancing and layout.

Experience with process validation within a regulated Quality System environment.

Experience with Assembly Fixture Design.

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
09Jan
Production Planner
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

The Planning function works closely with Purchasing and Manufacturing to optimise material flow from suppliers, through the manufacturing processes, to availability for shipping to the regions as finished products, in a timely manner. Growth means an increasing reliance on best practise inventory control systems to keep timely yet minimum materials at each stage of the supply chain. This incumbent will manage the day-to-day planning functions for manufacturing whereby maximising efficiency and customer service level whilst supporting changing demands with minimum inventory level and cost. This role will be reporting to the Logistics Manager and will be based in Tuas.

Let’s talk about responsibilities:

Creation of production plans that balance of capacity an customer needs, optimise production and minimise costs in resources and inventory

Maintenance of planning system parameters to optimise planning outputs and efficiency

Creation of work orders for production

Monitoring and reporting of schedule attainment

Coordination between purchasing, manufacturing, suppliers and sales operations to ensure customer requirements are met in a timely and efficient manner

Maintain communication between all departments to ensure visibility of manufacturing issues and customer needs

Let’s talk about qualifications and experience:

At least Diploma in Manufacturing / Engineering with 3 years experience in a production and material planning function in a manufacturing environment

Preferrable if you have 5 years experience in a production and material planning function in a manufacturing environment.

Proficient in MS office applications, ERP system (Oracle/SAP) with good knowledge of supply chain, material flow concepts and production planning reporting/metrics

Strong ownership and exhibit high sense of urgency

Good problem solving ability and strong communication skills

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
09Jan
Systems Engineer/Senior Systems Engineer
ResMed   via Glassdoor

The Respiratory Care team is transforming the way in which Chronic Obstructive Pulmonary Disease (COPD) care is managed and delivered though our non-invasive ventilation and portable oxygen solutions. This means we identifying the pain points for patients, providers and payers and developing deeper insights into the unmet needs of COPD patients. We see a future in which resources and technology are less focused on the diagnosis and treatment    Read more

of the disease and more oriented to prevention of COPD exacerbations and the slowing of disease progression.

Let's talk about responsibilities:

Define design structure to provide desired functionality per product and user requirements and Regulatory Standards for applicable regions.

Work with engineering disciplines to translate user requirements and usage scenarios into system and design specifications to ensure product achieves performance, functionality and reliability.

Deliver and maintain Functional / System Specifications.

Ensure full traceability of requirements.Identify and evaluate technical design alternatives to achieve desired functionality with approval from XFT and Section Leader.

Resolve technical issues with the engineering disciplines and review issues with the XFT where required.

Represent systems engineering at the XFT.

Define and ensure the system components will integrate successfully to appropriate quality levels.Interface with other project stakeholders to ensure that the system objectives are balanced with overall project objectives.

As part of Technical Competencies provide technical mentoring & training to the broader Product Development Group as required on Systems Engineering.

Complete and maintain the system Risk Analysis.

Ensure rigorous documentation for all phases of development, including design specifications, verification test plans, and project schedules.

Work with V&V department to define the Verification and Validation plan to demonstrate that product meets technical specification and each user requirement and usage scenario.

Ensure risk of non-compliance and related business risks are mitigated at every stage of the development process.

Identify, define and communicate compliance requirements for all aspects of projects.

Develop measures, feedback and reporting mechanisms for Senior Management.

Ensuring that ResMed Systems Engineering Processes are adhered to and recommend updates to processes where appropriate.

Develop and support the product development documentation management system and procedures and policies to ensure that products are developed to meet ResMed’s performance & quality expectations.

A commitment to continuous improvement and a strong desire to improve the activity of product development.

Maintain a broad knowledge of company products, competitors, and customer’s needs.

Supporting Manufacturing for initial and ongoing production needs.

Supporting Sustaining engineering for released products.

Observe the principles of Occupational Health & Safety Legislation.

Let’s talk qualifications and experience:

Engineering degree with significant broad based, commercial experience.

Experience in New Product Development environment.

Proven effective communication / technical leadership to professional staff.

Significant System engineering experience and/or Project Management skills.

Engineering degree with post grad qualification and significant project management.

Medical device industry experience or related experience in a similarly regulated environment preferred

Formal training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics.

Demonstrates a superior knowledge of regulations and customer specifications and their impact on design parameters (i.e. marketing, clinical, regulatory, manufacturing, quality, IP.

#LI-CC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills
ResMed
09Jan
Quality Assurance Engineer, Pft
ResMed   via Glassdoor

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve    Read more

efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let’s talk about the team and you:

We are seeking quality management system (QMS) and product quality (PFT) expert, in the position of Quality Assurance (QA) Engineer, PFT. this position will initially be based in Loyang and relocate to Tuas new site in 2020. This Individual Contributor plays a crucial role within the Quality Assurance and Regulatory Affairs (QARA) Organisation, ensuring all quality aspects and deliverables at appropriate levels. You will be instrumental in defining quality and process improvements through collaboration with cross functional teams in Manufacturing. As a member of the QA Manufacturing team, this role will provide support and guidance to PFT and take a leadership role in new product introduction. Close loop and end to end system and process design will be required encompassing GMP and quality considerations.

Let’s talk about the responsibilities:

Support the Factory Focus teams to achieve current KPI of Quality, Delivery and CostLead and support new products introduction process into manufacturing with active involvement in appropriate XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team

Pro-actively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and site

Ensure risk of non-compliance and related business risks are mitigated

Provide technical leadership in Quality Engineering through mentoring/training

Build positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growth

Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements and provide coaching and guidance to PFT on an ongoing basis

Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards

Let’s talk Qualifications and Experience:

To really get us excited, you will have a Degree in Engineering or Science or other Tertiary qualifications deemed appropriate for this position with a minimum of 5 years’ experience in a regulated volume manufacturing environment.

Preferably with experience in new product introduction process, improving and introduce new procedures.

Extensive exposure in QMS and product quality Strong knowledge of FDA Quality System Regulations, GMP and appropriate ISO Standards and understanding of total quality and best practices in medical device industry

Self-starter, with the ability to work with minimal supervision and with a sense of urgency.

Good analytical ability and excellent relationship management skills

Excellent communication, planning and documentation skills, including summary report writing

Accountable and manage competing priorities in demanding environment.

#LI-LC2

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

Skills