Senior Design Assurance Engineer

4 C Medical Technologies; Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending Account (FSA)

Life Insurance

401(k) Retirement Plan

Paid Holidays

PTO

Maternity/Paternity paid leave

Job summary

4 C Medical Technologies is seeking a Senior Design Assurance Engineer to drive design controls, risk management, and DHF maintenance for a transcatheter mitral heart valve system. You will support regulatory submissions and audits, coordinate across R&D, Clinical, Operations, and Regulatory Affairs, and mentor junior engineers in a fast-paced environment.

This role focuses on ensuring QMS compliance, managing DHF documentation, and contributing to PMA/CE Mark activities as the project advances.

Qualifications

• Bachelor’s degree in engineering or life sciences or equivalent experience.
• 5+ years in medical device development, manufacturing, quality engineering, or design assurance.
• Experience with FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, EU MDR.
• Demonstrated design controls, design documentation, and risk management experience.
• Strong technical writing and detail orientation.
• Ability to manage multiple priorities and communicate across functions.

Responsibilities

• Lead design assurance activities across the product lifecycle from development to commercialization.
• Own and support design controls, inputs/outputs, reviews, verification/validation, and transfer.
• Maintain DHF documents; ensure accuracy, traceability, and audit readiness.
• Develop and review risk management documentation per ISO 14971 (FMEAs, plans, reports).
• Lead assessments of new standards; drive remediation for compliance gaps.
• Prepare regulatory submission documentation (protocols, reports, risk docs).
• Provide QA/Regulatory support to R&D, Clinical, Operations, and Regulatory Affairs.
• Support FDA, notified bodies, and internal audits of design/development docs.
• Assist manufacturing IQ/OQ/PQ and process/equipment qualification.
• Drive continuous improvement in design assurance and product development processes.
• Mentor junior engineers and lead cross-functional projects.

Skills

Design controls

Risk management

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Minitab

Job description

Description

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement system through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.

THE OPPORTUNITY

We are seeking a Senior Design Assurance Engineer to play a key role in the design, development, and commercialization of our transcatheter mitral heart valve replacement. This role will be instrumental in ensuring our product development activities meet global quality and regulatory requirements while supporting critical milestones toward PMA and CE Mark approval.

This is an opportunity to work at the intersection of engineering, quality, regulatory, and product development, with significant ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities.

HOW YOU WILL CONTRIBUTE

• Lead design assurance activities throughout the product lifecycle, from new product development through commercialization.
• Own and support design controls, including design inputs, outputs, design reviews, verification and validation, and design transfer.
• Lead development 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 ISO 14971, including risk analyses, FMEAs, risk management plans, and reports.
• Lead assessments of new and revised standards, identify compliance gaps, and drive remediation activities.
• Author and review technical documentation supporting regulatory submissions, including protocols, reports, and risk documentation.
• Provide design assurance and quality engineering support to R&D, Clinical, Operations, and Regulatory Affairs.
• Support FDA, notified body, and internal audits and inspections, particularly those involving design and development documentation.
• Support manufacturing process and equipment qualification activities, including IQ, OQ, and PQ.
• Drive continuous improvement across design assurance, quality systems, and product development processes.
• Mentor junior engineers and provide leadership on projects and cross-functional initiatives.

Requirements

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS)

• Bachelor’s degree in Engineering, Life Sciences, or another technical field, or equivalent experience.
• 5+ years of experience in medical device development, manufacturing, quality engineering, or design assurance.
• Experience working within regulated medical device environments and applying FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR requirements.
• Demonstrated experience with design controls, design documentation, risk management, and/or Design History Files.
• Strong technical writing and documentation skills, with exceptional attention to detail.
• Strong analytical, problem-solving, project management, and communication skills.
• Ability to effectively manage multiple priorities and work collaboratively across functions.
• Ability to travel up to 10%.

WHAT WILL SET YOU APART (COMPETENCIES)

• Experience with structural heart or Class III implantable medical devices, particularly transcatheter valve technologies.
• Experience supporting PMA, CE Mark, or other major regulatory submissions.
• Strong experience with Design History Files and design assurance activities throughout the product development lifecycle.
• Experience with Nitinol processing, including forming, heat treatment, electropolishing, or surface finishing.
• Knowledge of ISO 5840 and ISO 10993-1 requirements.
• Experience with statistical tools such as Minitab.
• Demonstrated ability to lead projects, influence cross-functional teams, and mentor junior engineers.
• Comfortable 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.

WHY JOIN US

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.