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:

• Bachelor’s Degree in Engineering, Science, or a closely related field; Master's or Ph.D. preferred.
• Minimum of 8 years of experience in design assurance or quality engineering within the medical device sector.
• Strong background in regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and IEC 60601.
• Proficient in risk management methodologies and design control frameworks.
• Demonstrated ability to lead projects and teams in a fast-paced environment.
• Exceptional analytical skills and proficiency in using statistical analysis tools.
• Excellent written and verbal communication skills, with the ability to articulate complex concepts to diverse audiences.
• Proven track record of successful interactions with regulatory bodies.
• Experience in leading process improvement initiatives and implementing quality management systems.

Benefits

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

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

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.