Senior Design Assurance Engineer

Nextern is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.

DUTIES AND RESPONSIBILITIES:

· Lead the design assurance activities and support product development through design verification and validation.

· Develop and execute risk management and design control documents, including DHF, DMR, and technical files.

· Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.

· Analyze testing data and prepare technical documentation for submissions to regulatory bodies.

· Oversee design reviews and provide constructive feedback to team members.

· Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.

QUALIFICATIONS:

· Bachelor’s Degree in Engineering or a related field; Master’s preferred.

· Minimum of 5 years of experience in design assurance within the medical device industry.

· In-depth understanding of design control and risk management principles.

· Proven experience with FDA, ISO, and IEC regulations and standards.

· Proficient in statistical analysis software and methodologies.

· Strong communication skills and ability to work collaboratively in cross-functional teams.

· Demonstrated problem-solving abilities and attention to detail.

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

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.