Senior Design Assurance Engineer

Actalent; Maple Grove (MN); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

FSA

Basic Life

401(k)

Paid Holidays

PTO

Maternity/Paternity leave

Job summary

Actalent in Maple Grove, MN is seeking a Senior Design Assurance Engineer to lead design controls, risk management, and DHF strategy for a next-generation catheter system. You will collaborate with Engineering, Regulatory, Clinical, and Operations to ensure compliant development and successful commercialization.

The role requires 5+ years in design assurance or medical device quality, strong technical writing, and leadership across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 5+ years of experience in Design Assurance, Quality or Medical Device Quality.
• Experience in FDA-regulated medical devices and Design Controls.
• Experience supporting DHFs, traceability, and documentation.
• Strong writing, analytical, and problem-solving skills.
• Ability to lead projects and influence cross-functional teams.
• Strong communication and stakeholder management.

Responsibilities

• 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.

Skills

Design controls

Risk management

Technical writing

Project leadership

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering or Life Sciences

Job description

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.

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.

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

Workplace Type

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

Application Deadline

This position is anticipated to close on Sep 23, 2026.

About Actalent

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.

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.

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.

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.

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.