Senior Design Assurance Engineer

Senior Design Assurance Engineer

This Senior Design Assurance Engineer role offers the opportunity to lead design assurance activities for a transcatheter mitral heart valve replacement from early-stage development through commercialization. You will work at the intersection of engineering, quality, regulatory, and product development to ensure that all design and development activities meet global quality and regulatory requirements and support critical milestones toward major regulatory approvals. In this position, you will take significant ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities while partnering closely with cross-functional teams. You will contribute directly to advancing a Class III structural heart device through pivotal clinical trials and help deliver a high-quality product that can make a meaningful difference for patients.

Responsibilities

• Lead design assurance activities throughout the entire product lifecycle, from new product development through commercialization.
• Own and support design controls, including defining and managing design inputs and outputs, leading design reviews, and overseeing design verification, validation, and design transfer activities.
• Lead the development, organization, and maintenance of Design History Files (DHF), ensuring documentation is accurate, traceable, complete, and audit-ready.
• Author and review risk management documentation in accordance with applicable ISO standards, including risk analyses, risk evaluations, risk management plans, and risk management reports.
• Assess new and revised standards, identify compliance gaps, and drive remediation activities to maintain alignment with global regulatory and quality requirements.
• Author and review technical documentation that supports regulatory submissions, including protocols, reports, and risk documentation.
• Provide design assurance and quality engineering support to Research and Development (R&D), Clinical, Operations, and Regulatory Affairs teams.
• Support FDA, notified body, and internal audits and inspections, particularly those involving design and development documentation and design controls.
• Support manufacturing process and equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Drive continuous improvement across design assurance, quality systems, and product development processes to enhance efficiency, compliance, and product quality.
• Mentor junior engineers, providing guidance on design assurance practices, and offer leadership on projects and cross-functional initiatives.
• Collaborate with cross-functional teams to manage multiple priorities and ensure timely completion of design assurance deliverables.
• Apply strong analytical, problem-solving, and project management skills to resolve issues and ensure robust design and process controls.

Essential Skills

• Bachelor's degree in Engineering, Life Sciences, or another technical field, or equivalent experience.
• At least 5 years of experience in medical device development, manufacturing, quality engineering, or design assurance.
• Experience working within regulated medical device environments and applying FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820 requirements.
• Experience applying ISO-based quality and risk management standards and European Union Medical Device Regulation (EU MDR) requirements.
• Demonstrated experience with design controls, including design documentation, design inputs and outputs, design reviews, and design transfer.
• Demonstrated experience with risk management activities and Design History Files (DHF).
• Strong technical writing and documentation skills with exceptional attention to detail.
• Strong analytical and problem-solving skills with the ability to interpret complex data and make sound, practical decisions.
• Strong project management skills with the ability to manage multiple priorities and deliver results on time.
• Effective communication skills with the ability to work collaboratively across functions such as R&D, Clinical, Operations, and Regulatory Affairs.
• Ability to travel up to 10%.

Additional Skills & Qualifications

• Experience with structural heart or Class III implantable medical devices, particularly transcatheter valve technologies.
• Experience supporting Premarket Approval (PMA) or other major regulatory submissions.
• Strong experience with Design History Files and design assurance activities across the full product development lifecycle.
• Experience with metal processing, including forming, heat treatment, electropolishing, or surface finishing.
• Knowledge of ISO 5840 and ISO -1 requirements related to heart valve devices.
• Experience using statistical tools such as Minitab for data analysis and verification and validation activities.
• Demonstrated ability to lead projects and influence cross-functional teams without direct authority.
• Demonstrated experience mentoring junior engineers and fostering their professional growth.
• Comfort working in a fast-paced, evolving environment where priorities may change and individuals are expected to take ownership and drive results.
• Strong combination of technical depth, attention to detail, sound judgment, and practical problem-solving skills.
• Experience with new product development, design verification, design validation, and research and development engineering.
• Background in medical device design assurance, design control, and risk management within a quality-focused organization.

Work Environment

This role is based on-site in Maple Grove, MN, within a growing medical device organization focused on developing innovative technology for the treatment of mitral valve disease. You will work in a collaborative, cross-functional environment alongside engineering, clinical, operations, and regulatory teams, with direct exposure to Class III structural heart device development and pivotal clinical trial activities. The culture emphasizes accountability, curiosity, shared purpose, and continuous improvement, with a strong focus on delivering high-quality products that positively impact patients' lives. The organization prioritizes both personal and professional development, providing opportunities to contribute ideas, take ownership of work, and see the direct impact of your contributions on the success of the product and the company.

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 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

It is 4C Medical's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.

Workplace Type

This is a fully onsite position in Maple Grove, MN.

Application Deadline

This position is anticipated to close on Sep 10, 2026.