R&d Engineer

Job Title: R&D Engineer – EU Medical Device Regulation (EU MDR) Job Description This role seeks an experienced R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to drive the design, development, documentation, and compliance strategy for medical devices intended for the EU market. You will apply a strong engineering foundation and hands-on experience with EU MDR requirements across the product lifecycle, ensuring products meet both technical performance expectations and global regulatory obligations. As a key member of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to deliver safe, effective, and compliant medical devices. Responsibilities Lead and support remediation design activities for medical devices in accordance with EU MDR 2017/745 and applicable international standards. Conduct engineering studies, testing, and technical evaluations to ensure design controls are fully aligned with regulatory and quality system requirements. Generate comprehensive technical documentation, including design inputs and outputs, risk analyses, verification and validation protocols, and test reports. Develop, update, and maintain Technical Documentation and Technical Files that satisfy EU MDR Annex II and Annex III requirements. Ensure compliance with General Safety and Performance Requirements (GSPR) and support associated documentation and justification. Support clinical evaluation, post‑market surveillance, and post‑market clinical follow‑up documentation as needed for EU MDR compliance. Perform and maintain risk management activities in alignment with relevant ISO risk management standards for medical devices. Lead or support FMEA, fault‑tree analysis, and other structured risk assessment tools to identify, evaluate, and mitigate product risks. Collaborate with Quality to ensure design documentation, Design History Files (DHFs), and updates meet internal standard operating procedures and external regulatory requirements. Support manufacturing transfer activities and design changes, ensuring that modifications remain compliant with EU MDR and quality system controls. Contribute to project planning, schedule development, and technical decision‑making within cross‑functional project teams. Design and execute verification and validation (V&V) testing to demonstrate product safety, performance, and regulatory compliance. Lead investigations of design issues, corrective and preventive actions (CAPAs), and nonconformances impacting EU markets, and drive effective remediation. Coordinate with Regulatory Affairs and other stakeholders to prepare for and support Notified Body audits, questions, and remediation activities related to EU MDR compliance. Essential Skills Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or a related engineering field. Several years of experience working in research and development within the medical device industry. Demonstrated experience preparing EU MDR‑compliant technical documentation for medical devices. Strong understanding of design controls in accordance with 21 CFR 820.30. Solid knowledge of ISO and IEC/ISO standards relevant to medical devices and the specific product type. Proven experience interacting with Notified Bodies or supporting Notified Body audits for medical devices. Excellent technical writing skills with the ability to produce clear, audit‑ready documentation. Hands‑on experience with risk management methodologies such as FMEA and fault‑tree analysis in a medical device context. Ability to collaborate effectively with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams. Strong analytical and problem‑solving skills applied to design issues, CAPAs, and nonconformances. Additional Skills & Qualifications Experience working with Class IIb or Class III medical devices. Prior experience supporting EU Medical Device Directive (MDD) to EU Medical Device Regulation (MDR) transition projects. Experience coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions. Proficiency with SolidWorks for mechanical design and modeling. Experience using Windchill or similar product lifecycle management (PLM) systems. Experience following IEC standards for medical electrical equipment safety requirements. Experience in medical device risk management aligned with ISO risk management standards. Familiarity with post‑market surveillance and post‑market clinical follow‑up processes. Comfort working in a hybrid environment with occasional lab and testing activities. Work Environment This hybrid role is based in Denver, Colorado and offers a mix of office-based work and hands‑on engineering activities. You will spend time collaborating with cross‑functional teams as well as performing occasional lab work, device testing, and technical evaluations. The position may require occasional travel, estimated at less than 10%, for training, team meetings, or collaboration with other sites. The environment supports detailed technical documentation, design and risk analysis, and verification and validation activities using tools such as SolidWorks and Windchill, along with standard laboratory and test equipment for medical devices. Job Type & Location This is a Contract position based out of Centennial, CO. Pay and Benefits The pay range for this position is $57.69 - $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 remote position. Application Deadline This position is anticipated to close on Aug 14, 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 [email protected] 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.