Sr. Design Assurance Engineer

The Design Assurance Engineer, also known as the Product Assurance Engineer (Quality Engineer), is responsible for leading product assurance activities that support commercial production. This includes tasks such as inspection, product release, handling nonconforming materials, and analyzing product complaints. The role requires collaboration with Design Assurance on risk management updates and the transfer of design documentation into production, while ensuring product requirements are met in conjunction with Manufacturing and Supply Chain. Responsibilities

• Lead process Failure Mode and Effects Analysis (PFMEA) development and ongoing updates.
• Develop and plan product inspection strategies, including requirements for purchased products and measurement methodologies.
• Support supplier evaluation, auditing, and performance monitoring.
• Assist in the development of in-process and final product testing.
• Collaborate with Design Assurance on risk-management activities and review design documentation, including product design requirements and design verification test protocols.
• Ensure procedures, practices, and documentation comply with applicable standards and regulations in collaboration with Design Assurance and Manufacturing Engineering.
• Support the transfer of specifications and processes 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.
• Utilize statistical methods to support inspection, testing, and process-validation activities.
• Conduct product complaint analysis, including risk-management file reviews and updates.
• Act as a subject-matter expert during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis.
• Develop, modify, and maintain quality-system procedures, work instructions, and forms.
• Support internal and external audit activities.
• Lead CAPA investigations, action planning, and follow-up for assigned CAPAs.

• 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., * Bachelor’s degree with at least 5 years of relevant medical-device experience, or
• Advanced degree with at least 3 years of relevant medical-device experience.
• Experience with medical devices and ISO standards.
• Knowledge of CAPA, engineering, and development processes., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.