Senior Medical Device Design Assurance Lead

Actalent; Plymouth (MN); Hybrid; USD 73,000 - 83,000; Full time

Job summary

Actalent in Plymouth, MN is seeking a Design Assurance Engineer to lead product assurance activities across PFMEA, inspection planning, and product release for medical devices.

The role collaborates with Design Assurance, Manufacturing, and Quality to ensure design controls, risk management, and regulatory compliance are embedded in development and transfer to production. This is a contract-to-hire hybrid position with 3 days in the office and 2 days remote.

Qualifications

• Experience in design control and risk management.
• Proficiency in validation and design assurance.
• Expertise in new product development and quality assurance.
• Strong knowledge in mechanical and process development.
• Proven experience in quality engineering.

Responsibilities

• Lead PFMEA development and updates.
• Develop product inspection plans and measurement methodologies.
• Support supplier evaluation, auditing, and performance monitoring.
• Assist in development of in-process and final product testing.
• Review design documentation and risk-management activities.
• Ensure procedures and documentation meet standards with Design Assurance and Manufacturing.
• Lead CAPA investigations and follow-up.
• Perform product complaint analysis and risk-management updates.
• Maintain quality-system procedures and forms.
• Support internal and external audits.

Skills

Design control

Risk management

Validation

New product dev

Quality engineering

Education

Bachelor's degree in related field

Advanced degree

Job description

Actalent in Plymouth, MN is seeking a Design Assurance Engineer to lead product assurance activities across PFMEA, inspection planning, and product release for medical devices.

The role collaborates with Design Assurance, Manufacturing, and Quality to ensure design controls, risk management, and regulatory compliance are embedded in development and transfer to production. This is a contract-to-hire hybrid position with 3 days in the office and 2 days remote.