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Together with our customers, we're on a mission to make healthcare better.
The Role
Support New Product Development design assurance for orthopedic medical devices, focusing on risk management, usability engineering, design control documentation, and migrating risk content between systems. Engage cross-functionally, apply quality tools (FMEA, GD&T, root cause analysis), support system implementations, and communicate project status, risks, and deliverables to ensure compliant execution.
Summary Generated by Built In
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:• Bachelor’s 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________________________________________________________________________________
Skills Required
- Bachelor's Degree in Engineering (Biomedical, Mechanical, or related)
- Minimum 2+ years as a Quality Engineer, Design Assurance Engineer, or engineer in a regulated design environment
- Experience within the medical device product development life cycle
- Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971
- Knowledge of EU Medical Device Regulation (MDR)
- Applied knowledge of advanced quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing/Poka Yoke)
- Experience with risk management, usability engineering, and/or design control documentation in medical device development
- Experience using Jama, Integrity, or similar systems to document/manage/trace risk, usability, requirements, or design control information
- 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 stakeholders
- Ability to independently manage priorities, own deliverables, and meet deadlines
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
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The Company
What We Do
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. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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