Senior Design Assurance Engineer

ACTalent; Minneapolis (MN); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA

Basic Life

401(k) Retirement Plan

Paid Holidays

PTO

Parental Leave

Job summary

ACTalent is seeking a Design Assurance Engineer to lead design assurance activities for a next-generation medical device, collaborating with Engineering, Regulatory, Clinical, and Operations teams to meet global quality and regulatory standards.

You will drive design controls, maintain the DHF, and lead risk management per ISO 14971, while mentoring engineers and guiding cross-functional teams through product development and regulatory submissions.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years in Design Assurance, Quality Eng, or Medical Device Quality Systems.
• Experience in FDA-regulated medical devices.
• Strong Design Controls and product development processes.

Responsibilities

• Lead design assurance across new product development and commercialization.
• Drive design control activities including planning, inputs, outputs, reviews, verification, validation, and design transfer.
• Own DHF strategy, maintenance, and audit readiness.
• Lead risk management per ISO 14971 and regulatory requirements.
• Author and review risk analyses, risk management plans, reports, protocols, and technical documentation.
• Partner with Engineering to ensure traceability, verification, and validation of requirements.
• Support regulatory submissions through development of technical and quality documentation.
• Collaborate with Clinical, Operations, Manufacturing, and Regulatory Affairs for 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 to strengthen processes and quality systems.
• Mentor engineers and provide technical leadership across projects.

Skills

Design Assurance

Quality Engineering

Regulatory Knowledge

Risk Management

Design Controls

Technical Writing

Project Leadership

FDA Experience

Cross-functional

Communication Skills

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Minitab

Job description

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.

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 environment

Job Type & Location

This is a Permanent position based out of Minneapolis, 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. 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.

• Medical
• Dental
• Vision
• Flexible Spending Account (FSA)
• Basic Life
• 401(k) Retirement Plan
• Paid Holidays
• PTO
• Maternity/Paternity paid leave

Application Deadline

This position is anticipated to close on Nov 18, 2026.

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Equal Opportunity Employer

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.

Reasonable Accommodation

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 [e-mail] for other accommodation options.

City Discrimination Exceptions

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Artificial Intelligence Usage

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.