Medical Device Verification Lead - Lab Projects

Nemera; Chicago, Northern (IL, KY); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Nemera Insight Chicago is seeking a Lab Project Specialist to lead verification activities for medical devices. The role requires deep expertise in device testing, design inputs, risk analyses, and robust verification strategies across the product development lifecycle.

The ideal candidate has a strong engineering background, can independently determine required tests, and will work with R&D, Lab, Quality, Regulatory Affairs, and external partners to ensure design requirements are met.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical, Systems Eng or related.
• 3+ years in medical device development, verification or testing.
• Experience developing verification strategies and executing verification programs.
• Strong knowledge of medical device design controls and development processes.
• Experience creating test methods and analyzing data.
• Excellent technical writing and communication skills.
• Ability to assess designs and determine verification approaches.
• Experience working in lab or clean room with PPE.

Responsibilities

• Develop and implement verification strategies for new and existing devices.
• Review requirements, design inputs, and risk analyses to determine verification activities.
• Create verification protocols, test plans, acceptance criteria, and reports per design control requirements.
• Ensure objective evidence demonstrates compliance with design requirements.
• Mentor junior engineers and provide leadership in verification practices.

Skills

Verification strategy

Data analysis

Technical writing

Lab work

Communication

Education

Bachelor's degree

Tools

Minitab

JMP

Test equipment

Job description

Nemera Insight Chicago is seeking a Lab Project Specialist to lead verification activities for medical devices. The role requires deep expertise in device testing, design inputs, risk analyses, and robust verification strategies across the product development lifecycle.

The ideal candidate has a strong engineering background, can independently determine required tests, and will work with R&D, Lab, Quality, Regulatory Affairs, and external partners to ensure design requirements are met.