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.

Requirements

• 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

• 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