EU MDR Specialist - R&D Engineer

Job Description

We are seeking an experienced R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands-on experience navigating EU MDR requirements throughout the product lifecycle. As part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations.

Responsibilities

Lead and support remediation design activities for medical devices in accordance with EU MDR.Conduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements.Generate technical documentation including design inputs/outputs, risk analyses, verification and validation protocols, and test reports.Develop, update, and maintain Technical Documentation (TD) and Technical Files to satisfy EU MDR Annex II and III requirements.Ensure compliance with General Safety and Performance Requirements (GSPR).Support clinical evaluation, post-market surveillance, and post-market clinical follow-up documentation as needed.Perform and maintain risk management activities, supporting FMEA, fault-tree analysis, and other risk assessment tools.Work with Quality to ensure design documentation, DHFs, and updates meet internal SOPs and external regulatory standards.Support manufacturing transfer activities and design changes.Contribute to project planning, schedule development, and technical decision making.Design and execute verification and validation (V&V) testing to demonstrate safety, performance, and regulatory compliance.Lead investigations of design issues, CAPAs, and nonconformances impacting EU markets.

Essential Skills

Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related Engineering field.3–7+ years of experience in R&D within the medical device industry.Demonstrated experience preparing EU MDR–compliant technical documentation.Thorough understanding of design controls (21 CFR 820.30) and ISO/IEC standards related to the product type.Proven experience interacting with Notified Bodies or supporting NB audits.Excellent technical writing skills and ability to produce audit-ready documentation.

Additional Skills & Qualifications

Experience with Class IIb or Class III medical devices.Prior experience with EU MDD-to-MDR transition projects.Experience with coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions.SolidWorks and Windchill experience.Experience following IEC medical electrical equipment safety requirements.

Work Environment

This position is 100% onsite based in Denver, Colorado. The role requires occasional lab work, device testing, and hands-on engineering activities. There may be occasional travel, less than 10%, for training or team meetings. The company offers 2 weeks of PTO and 6 paid holidays.

Job Type & Location

This is a Contract position based out of Centennial, CO.

Pay and Benefits

The pay range for this position is $55.00 - $57.69/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Centennial,CO.

Application Deadline

This position is anticipated to close on Feb 27, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.