Work Flexibility: Hybrid

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

As a Senior New Product Development Quality Engineer for Surgical Technologies, 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.

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 a science, engineering or related discipline 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.

• A minimum of 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).

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.