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Seeking a Senior Design Assurance Engineer!Job Description

We are seeking a Senior Design Assurance Engineer to lead design assurance activities throughout the product lifecycle, from concept development to commercialization and post-market surveillance. The ideal candidate will collaborate with cross-functional teams to ensure design inputs are clearly defined and translated into robust design outputs, support verification and validation activities to demonstrate product performance and compliance with regulatory requirements, and lead risk analysis activities to identify and mitigate potential hazards associated with product design and manufacturing processes.

Responsibilities

• Lead design assurance activities throughout the product lifecycle, from concept development to commercialization and post-market surveillance.

• Collaborate with cross-functional teams to ensure design inputs are clearly defined and translated into robust design outputs.

• Support verification and validation activities (including software validation) to demonstrate product performance and compliance with regulatory requirements (e.g., FDA, ISO).

• Lead risk analysis activities to identify and mitigate potential hazards associated with product design and manufacturing processes and maintain the Risk Management File.

• Establish and maintain design control procedures, ensuring adherence to applicable standards and regulations.

• Lead and implement complex projects including quality improvement initiatives.

• Support change control activities for established products.

• Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities, and develop statistically sound tolerance limits.

• Foster a culture of quality and compliance within the organization by promoting awareness and adherence to relevant policies and procedures.

Essential Skills

• 5+ years of experience as a Quality Engineer within the medical device industry.

• Bachelor's degree in Engineering (Mechanical, Material Science, or Biomedical) or related Science.

• Strong understanding of design control principles, FDA regulations (e.g., 21 CFR 820), and international standards (e.g., ISO).

• Proficiency in risk management methodologies and tools (e.g., FMEA, fault tree analysis).

• Experience with verification and validation activities, including test method development and execution.

• Excellent analytical and problem-solving skills, with the ability to prioritize and manage multiple tasks in a fast-paced environment.

• Effective communication and interpersonal skills, with the ability to collaborate effectively across diverse functional teams.

• Detail-oriented mindset with a commitment to upholding high standards of quality and compliance.

Additional Skills & Qualifications

• Familiarity with design and analysis tools (e.g., CAD software, statistical software) is desirable.

About Actalent

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.