Senior Design Assurance Engineer

Senior Design Assurance Engineer Are you passionate about developing innovative medical devices that improve and extend lives? We're seeking a Senior 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. Required Qualifications 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. Preferred Qualifications 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. Don't meet every qualification?

We encourage you to apply. We recognize that exceptional candidates may bring valuable experience from related medical device disciplines and regulatory environments. Job Type & Location This is a Permanent position based out of Maple Grove, MN. Pay and Benefits The pay range for this position is $120000.00 - $130000.00/yr. 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. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial