The Role
Lead design quality engineering for orthopedic medical devices, focusing on risk management, usability engineering, design controls, and cross-functional compliance. Drive FMEA, usability evaluations, design reviews, DHF documentation, and continuous improvement throughout new product development.
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 domain
- 4-7 years of relevant experience
- Experience working in regulated environments: FDA QSRs and ISO 13485 Design Control Procedures
- Knowledge and application of IEC 62366-1 and ISO 14971 (usability engineering and risk management)
- Experience with Product Lifecycle Management (PLM) tools and requirement management tools (e.g., Jama)
- Experience with project management tools (e.g., JIRA)
- Demonstrated 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 creation and organization
- Experience with 3D CAD software, especially PTC Creo, and experience with surgical trays
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
