Senior Product Safety and Compliance Engineer- Medical Devices

The Senior Product Safety and Compliance Engineer will lead multiple certification projects from product concept to mass production, ensuring that all market access requirements are met and that product designs employ appropriate risk mitigation solutions. This role includes active participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.

Requirements

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline
• Relevant discipline context: Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems compliance
• Minimum 5+ years of compliance or design-related experience with consumer, commercial, or medical electromechanical products

Benefits

• medical insurance
• dental insurance
• vision insurance
• flexible spending accounts
• health savings accounts (HSA) with company contribution
• 401(k) retirement plan with matching
• employee stock purchase program
• life insurance
• AD&D
• short-term disability insurance
• long-term disability insurance
• generous paid time off
• company holidays
• parental leave
• identity theft protection
• pet insurance
• pre-paid legal insurance
• back-up child and eldercare days
• product discounts
• referral bonus program