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Job Details
This is a permanent hybrid role in our Innovation Centre with full Stryker benefits.
Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.
What you will do:
- Develop quality assurance documentation to support new product development process and regulatory submissions.
- Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
- Partner with cross-functional project teams to lead product and/or process design and development activities.
- Lead risk management activities for new product development projects.
- Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
- Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
- Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Partner with Advanced Operations in the development of manufacturing processes for new products.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
- Develop, review, and approve inspection plans, routers, and product drawings for new products.
- Support product design transfers to internal and/or external manufacturing facilities.
- Provide support and direction for other Quality Engineers.
- Evaluate predicate products for relevant quality issues tthat may impact new product development projects.
- Analyze and define critical quality attributes for product and process through risk analysis techniques.
- Participate in collection of initial market feedback on new products and address early concerns.
- Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
What you will need:
- BS in a science, engineering or related discipline (Level 8).
- Minimum of 4 years experience preferred.
IJ#
Posted Date: 01/15/2026
This role will be posted for a minimum of 3 days.
Required Skills
Company Details
Stryker
Kalamazoo, MI, United States
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative... Read more