JCW Group
Posted: 24/04/2025 Location: Plymouth, Minnesota, United States Job type: Contract
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.
Apply Now
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.
Apply Now