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 a dynamic start-up cardiovascular medical device company. This role will help ensure compliance with 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.