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Together with our customers, we're on a mission to make healthcare better.
The Role
Lead design quality engineering for orthopedic medical devices, focusing on risk management, usability engineering, design controls, and cross-functional regulatory compliance. Drive FMEA, usability evaluations, DHF documentation, and continuous improvement across NPD projects.
Summary Generated by Built In
Work Flexibility: Hybrid
What you will do-
- Support New Product Development (NPD) Design Quality Engineering activities for orthopedic medical devices, with a primary focus on risk management, usability engineering and design control as per the project and business need.
- Effectively collaborate with cross functional partners (Product Development, Regulatory Affairs, Quality, Clinical, Manufacturing, Packaging, Sterility, etc. and ensure compliance with applicable Quality System and regulatory requirements throughout the development process.
- Lead risk management and usability activities in accordance with applicable standards and internal procedures including formative and summative evaluations. Drive identification, assessment, and mitigation of product and process risks.
- Drive continuous improvement initiatives and identify opportunities to improve quality, efficiency, and consistency of deliverables.
What you will need-
Required skills-
- Bachelor's or master’s in mechanical engineering, bio-medical or similar domain.
- Experience- 4 years -7 years
- Experience of working in regulated environment such as FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1, and ISO 14971 and experience with Product Lifecycle Management (PLM) tools, requirement management tools (Jama etc) and project management tools (JIRA etc)
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing.
Preferred skills-
- Knowledge of EU Medical Device Regulation preferred
- Familiarity with design reviews and Design History File (DHF) documentation creation and organization.
- Experience with 3D CAD software, especially Creo from PTC and experience with surgical trays.
Skills Required
- Bachelor's or master's in mechanical engineering, biomedical engineering, or similar
- 4-7 years of relevant experience
- Experience working in regulated environments (FDA QSRs, ISO 13485)
- Knowledge of IEC 62366-1 and ISO 14971 (usability and risk management)
- Experience with PLM tools and requirement management tools (e.g., Jama)
- Experience with project management tools (e.g., JIRA)
- Applied knowledge of Advanced Quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing)
- Knowledge of EU Medical Device Regulation
- Familiarity with design reviews and Design History File (DHF) documentation
- Experience with 3D CAD software (especially Creo from PTC) and surgical trays
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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