Jobs → Design → Design Assurance Engineer

About the Role Stark Pharma is seeking experienced professionals for contract opportunities in the Medical Device industry. These roles focus on ensuring quality and compliance in medical device manufacturing and design. Key Responsibilities • Apply design controls, risk management, and FMEA principles • Conduct CAPA, root cause analysis, and post-market quality assessments • Maintain medical device quality systems according to ISO 13485 and ISO 14971 standards • Implement process validation and improvement initiatives • Ensure compliance with medical device engineering and regulatory requirements Requirements • 5+ years of experience for Design Assurance Engineer • Bachelor’s degree in Engineering or related technical field for Complaints Engineer • 8+ years of experience for Manufacturing/Process Engineer • Knowledge of metals manufacturing processes • Experience with medical device quality systems and regulatory compliance