Principal Engineer, Design Assurance

As a Principal Engineer, Design Assurance at Nextern, you will be at the forefront of ensuring the quality and safety of our innovative medical devices. Your expertise will play a critical role in guiding design assurance strategies and influencing best practices across multidisciplinary teams. This position is ideal for a seasoned professional who thrives in a challenging environment and is passionate about driving quality excellence in medical device engineering.

Key Responsibilities :

• Lead design assurance efforts for complex medical device projects, ensuring compliance with regulatory requirements and industry standards.
• Develop, implement, and oversee design control processes, including risk management, validation, and verification strategies.
• Collaborate with cross-functional teams to integrate design assurance principles into product development from concept through commercialization.
• Conduct design reviews and technical assessments to ensure design outputs meet established requirements.
• Mentor and provide guidance to junior engineers in best practices for design assurance and regulatory compliance.
• Engage with regulatory agencies on submissions and audits, providing expert technical insights.
• Continuously evaluate and improve design assurance processes and methodologies.
• Stay informed on the latest compliance trends and regulatory updates in the medical device industry.

Requirements

Qualifications :

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career :

The pay range for this position is $120,000 - $150,000.

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.