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Stryker is hiring a Senior New Product Development (Advanced) Quality Engineer (Hybrid)  in  Portage, Michigan , to support  Instruments !

In this role, you will influence Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. You will have the responsibility to drive reliability engineering, human factors engineering, risk management, and design validation, while ensuring compliance to Stryker quality system, FDA Quality System Regulations, ISO 13485 and other medical device regulations.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working three days onsite.

Who we want

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

• Develop quality assurance documentation to support new product development process and regulatory submissions.

• You will guide new product development teams through internal quality system requirements to launch new products.

• You will influence cross-functional project teams to build quality into product and/or process design and development activities.

• Support quality system maintenance by identifying and correcting deficiencies in procedures and practices.

• You will lead risk management for new development products, including risk analysis and development of sound mitigation strategies.

• Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.

• Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.

• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

• Support design engineering and advanced operations team in problem solving.

• Support Advanced Operations in the definition and development of manufacturing processes and process controls for new products.

• You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.

• Develop, review, and approve inspection plans, routers, and product drawings for new products.

• You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.

• Analyze and define critical quality attributes for product and process through risk analysis techniques.

• Support product design transfers to internal and/or external manufacturing facilities.

• Evaluate predicate products for relevant quality issues that may impact new product development projects.

• Participate in collection of initial market feedback on new products and address early concerns.

• You will lead formative and summative studies with our customers and other human factors engineering activities to develop intuitive and safe new products.

• You will lead design validation efforts to ensure new products meet all customer user needs.

• You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.

What you need

Required

• Bachelors in an engineering degree required.

• 2+ years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment.

Preferred

• Masters in a science, engineering or related discipline preferred.

• ASQ CQE, CRE, CSSBB or equivalent course work/experience desirable.

• 2+ years of experience as an NPD or design quality engineer is a distinct advantage.

• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.

• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

• Demonstrated ability to read and interpret CAD drawings.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.

• Thorough knowledge and understanding of US and International Medical Device Regulations.

• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

• Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.

• Demonstrated ability to advocate for product excellence and quality.

• Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

• Strong interpersonal skills, written, oral communication and negotiations skills.

• Strong in critical thinking and "outside the box" thinking.

• Highly developed problem-solving skills. Strong analytical skills.

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

• Demonstrated ability to work independently.

• Experience in working in a compliance risk situation.

• Computer literacy (including proficiency with Mini-Tab or similar analysis program).

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.