Job Summary

• Provide Design Quality Engineering support throughout the product development lifecycle to ensure compliance with regulations and internal Quality Management System procedures.
• Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Design Failure Modes and Effects Analysis (FMEA) and Risk Management Reports.
• Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.

Matching Summary

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Key Requirements

• Bachelor's degree in engineering or scientific discipline
• Minimum 5 years of work experience in a highly regulated industry
• Medical Device and/or Biotechnology industry experience preferred
• Working knowledge of quality system regulations (21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP, MDD/MDR)
• Experience in design control and risk management activities

Work Rights