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Senior Engineer, Design Assurance-NPD
Job Location:
Monthly Salary:
Posted:
28 June 2026 (30+ days ago)
Posted:
Application Deadline:
25 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Work Flexibility: Hybrid or Onsite
- Who we want
- Self-directed initiators.People who take ownership of their work and need no prompting to drive productivity efficiency change and outcomes.
- Collaborative partners.People who build and leverage cross-functional relationships to bring together ideas data and insights to drive continuous improvement in functions.
- Analytical problem solvers.People who go beyond just fixing to identify root causes evaluate optimal solutions and recommend comprehensive upgrades to prevent future issues.
What you will doAs a Senior Design Assurance Engineer you will support New Product Development (NPD) Design Assurance Engineering activities for orthopedic medical devices with a primary focus on risk management usability engineering design control documentation and the transition of risk management content from Integrity to Jama. This role may also support active NPD programs and related design assurance activities based on project and business needs.This role requires strong technical judgment the ability to quickly organize and manage work and clear communication of status risks barriers and next steps. You will engage cross-functionally with Design Assurance Product Development Regulatory Marketing Operations and other stakeholders to support compliant and timely execution in a highly regulated environment.- Knowledge of FDA QSRs ISO 13485 Design Control Procedures IEC 62366-1 and ISO 14971
- Knowledge of EU Medical Device Regulation preferred
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA) GD&T Root Cause Analysis and Mistake Proofing/Poka Yoke.
- Experience with risk management usability engineering and/or design control documentation within medical device product development
- Experience using an application or software system to document manage or trace risk management usability requirements or design control information; Jama Integrity or similar systems preferred
- Ability to support implementation of new systems tools or processes in a highly regulated environment
- Demonstrated ability to communicate complex plans technical information project status risks and open actions to team members and stakeholders
- Demonstrated ability to independently manage priorities own assigned deliverables respond to project needs and meet deadlines
What you need:Bachelors Degree in Engineering; Biomedical Mechanical or related discipline
Minimum 2 years of experience as a Quality Engineer Design Assurance Engineer or Engineer in a regulated design environment preferred
Experience within the medical device product development life cycle highly preferred
Required Experience:
Senior IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
