Sr. Design Assurance Engineer

Sr. Design Assurance Engineer

Location: Plymouth, MN
Employment Type: Contract to Hire
 

About the Role:

We are seeking a Design Assurance Engineer with a background in mechanical or biomedical engineering to join our dynamic, fast-paced team. This role will help ensure compliance with our internal SOPs and product lifecycle processes, and play a key part in preparing the organization for ISO 13485 certification and FDA audits.

Key Responsibilities:

• Ensure adherence to company’s APDP (Advanced Product Development Process) lifecycle SOPs (Phase 0–3).

• Monitor and enforce compliance with design control and quality guidance documents.

• Support audit readiness for FDA inspections and ISO 13485 certification.

• Collaborate with R&D to ensure documentation and processes align with regulatory expectations.

• Bring technical understanding to design reviews, supporting risk management and design inputs/outputs.

• Help optimize project plans and timelines without compromising compliance.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.

• Minimum 3–5 years of experience in design assurance or quality engineering in the medical device industry.

• Strong understanding of ISO 13485 and FDA regulations.

• Technical aptitude – ability to understand and discuss mechanical engineering principles

• Excellent organizational skills and attention to detail.

• Prior experience in a startup or dynamic development environment is a plus.