Senior Design Assurance Engineer (Medical Devices)

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, PFMEA development, and transfer of design into production. The role collaborates with Design Assurance, Manufacturing, and Supply Chain to ensure product requirements are met, with a focus on audits, CAPA, and process validation.

The ideal candidate has medical-device experience and strong expertise in design control, risk management, validation, and quality engineering.

Qualifications

• Design control and risk management experience required.
• Validation and design assurance experience.
• New product development and quality assurance experience.
• Experience with CAPA, audits, and regulatory expectations is a plus.

Responsibilities

• Lead PFMEA development and ongoing updates.
• Develop product inspection strategies and measurement methods.
• Support supplier evaluation, auditing, and monitoring.
• Assist in in-process and final product testing.
• Collaborate on risk-management activities and review design verification protocols.
• Ensure procedures and documentation comply with applicable standards with Design Assurance and Manufacturing Engineering.
• Lead transfer of specifications into production during design transfer.
• Facilitate equipment control and process validations.
• Review Device History Records (DHRs) and complete product release.
• Lead nonconforming material review and documentation.
• Use statistical methods to support inspection, testing, and process validation.
• Conduct product complaint analysis and risk-management reviews.
• Act as SME during audits and inspections for product inspection, PFMEA, NMN, and complaints.
• Develop, modify, and maintain quality-system procedures and forms.
• Support internal and external audit activities.
• Lead CAPA investigations and follow-up.

Skills

Design controls

Risk management

Validation

New product development

Quality engineering

Education

Bachelor's degree (medical-device)

Advanced degree (medical-device)

Job description

Actalent in Plymouth, MN is seeking a Design Assurance Engineer to lead product assurance activities, PFMEA development, and transfer of design into production. The role collaborates with Design Assurance, Manufacturing, and Supply Chain to ensure product requirements are met, with a focus on audits, CAPA, and process validation.

The ideal candidate has medical-device experience and strong expertise in design control, risk management, validation, and quality engineering.