Senior Design Assurance Engineer

Are you passionate about developing innovative medical devices that improve and extend lives? We’re seeking a Design Assurance Engineer to play a critical role in the development and commercialization of a next-generation catheter system. In this highly visible position, you’ll partner with Engineering, Clinical, Regulatory, and Operations teams to ensure product development activities meet global quality and regulatory requirements. This is an opportunity to make a measurable impact on patient care while working at the forefront of cardiovascular medical technology.

What You’ll Do

• Lead design assurance activities across new product development and commercialization efforts.
• Drive design control activities, including design planning, inputs, outputs, reviews, verification, validation, and design transfer.
• Own Design History File (DHF) strategy, maintenance, and audit readiness.
• Lead risk management activities in accordance with ISO 14971 and applicable regulatory requirements.
• Author and review risk analyses, risk management plans, reports, protocols, and technical documentation.
• Partner with Engineering teams to ensure product requirements are traceable, verified, and validated.
• Support regulatory submissions through development of technical and quality documentation.
• Collaborate with Clinical, Operations, Manufacturing, and Regulatory Affairs teams to ensure successful project execution.
• Assess new regulations and standards and lead compliance gap assessments.
• Support FDA inspections, notified body audits, and internal quality audits.
• Lead continuous improvement initiatives that strengthen product development processes and quality systems.
• Mentor engineers and provide technical leadership across cross-functional projects.

Visionary Operations Leadership Mentorship Innovation Orthopedics Traceability Communication Life Sciences Notified Body Risk Management Problem Solving Medical Devices Design Assurance Commercialization Technical Writing Electrophysiology Influencing Skills Regulatory Affairs ISO 14971 Standard Design Verification Statistical Analysis Technical Leadership Product Requirements Stakeholder Management New Product Development Manufacturing Processes Medical Device Reporting Engineering Design Process Verification And Validation Continuous Improvement Process Qualification Protocols (IQ/OQ/PQ) Title 21 Of The Code Of Federal Regulations

At least 5 years, * Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.

• 5+ years of experience in Design Assurance, Quality Engineering, Product Development Quality, or Medical Device Quality Systems.
• Experience working within FDA-regulated medical device environments.
• Strong understanding of Design Controls and product development processes.
• Experience supporting Design History Files (DHFs), traceability, and technical documentation.
• Experience applying risk management principles and ISO 14971 methodologies.
• Strong technical writing, analytical, and problem-solving skills.
• Ability to lead projects and influence cross-functional teams.
• Strong communication and stakeholder management skills., * Experience supporting Class III medical devices.
• Cardiovascular, structural heart, electrophysiology, neuromodulation, orthopedic, or other implantable medical device experience.
• PMA submission experience.
• Knowledge of FDA QMSR, 21 CFR Part 820, EU MDR, and ISO 13485.
• Experience supporting design verification and validation activities.
• Familiarity with manufacturing process validation, IQ/OQ/PQ, and transfer-to-production activities.
• Experience with statistical analysis tools such as Minitab.
• Prior mentoring or technical leadership experience.
• Knowledge of ISO 5840 or structural heart regulations., 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.

We recognize that meaningful work is supported by meaningful benefits. Thats why we offer a competitive compensation package along with comprehensive benefits designed to support you and your familys health, well-being, and financial future. Our benefits package includes: Medical Dental Vision Flexible Spending Account (FSA) Basic Life 401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave

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.