Medical Device/Combination Product Engineer
$60,000–$75,000 year
Hybrid · Vernon Hills, Illinois, United States
Job Summary
Medical Device/Combination Product Engineer role focusing on supporting design controls, DHF and risk management for medical devices and combination products. Responsibilities include assisting with DHF and Risk Management File development and maintenance, supporting product development activities (gathering user needs, design inputs, testing requirements), contributing to risk assessment (FMEAs), preparing/reviewing documentation for design verification/validation, researching applicable regulations (FDA 21 CFR 820, ISO 14971), and collaborating with Quality, Regulatory, Manufacturing, Human Factors, and Clinical teams to ensure traceability from requirements through testing; involvement in regulatory submissions and inspections. Preferred familiarity with ISO 13485, FMEA, DHF documentation, verification planning, and software tools (CAD, Minitab, MATLAB). Location: Northwest Chicago Suburbs or remote for the right candidate (W2 employee) with salary $60,000-$75,000 depending on experience.
Required Qualifications
- Bachelor's degree in Biomedical Engineering or related engineering discipline
- Understanding of design control, risk management, and product development lifecycle
- Strong written and verbal communication skills
- Detail-oriented with good documentation and organizational skills
- Team-oriented with a willingness to learn and grow in a fast-paced environment
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