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 from Integrity to Jama. Engage cross-functionally with stakeholders, support active NPD programs, implement systems/processes, and communicate status, risks, and next steps to ensure compliant, timely 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 discipline)
- Minimum 2+ years of experience 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
- Demonstrated applied knowledge of Advanced Quality tools such as 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 applications or systems to document/manage/trace risk management, usability, requirements, or design control information (Jama, Integrity, or similar)
- 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
- Demonstrated ability to independently manage priorities, own deliverables, respond to project needs, and meet deadlines
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.
-
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.
-
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.
-
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
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
