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