R&d Engineer

R&D Engineer – EU Medical Device Regulation (EU MDR)

This role focuses on leading research and development activities for medical devices intended for the EU market, with a strong emphasis on compliance with the EU Medical Device Regulation (EU MDR 2017/745). You will drive design, development, documentation, and regulatory strategy to ensure products meet both technical performance requirements and global regulatory obligations. Working as part of an R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to deliver safe, effective, and compliant medical devices throughout the product lifecycle.

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 that design controls fully align with regulatory and quality system requirements.
• Generate comprehensive technical documentation, including design inputs and outputs, risk analyses, verification and validation protocols, test reports, and other design control records.
• Develop, update, and maintain Technical Documentation and Technical Files to satisfy EU MDR Annex II and Annex III requirements.
• Ensure that designs and documentation comply with General Safety and Performance Requirements (GSPR) under EU MDR.
• Support the creation and maintenance of clinical evaluation, post-market surveillance, and post-market clinical follow-up documentation as needed.
• Perform and maintain risk management activities in alignment with relevant ISO risk management standards for medical devices.
• Lead or support risk assessment activities such as Failure Modes and Effects Analysis (FMEA), fault-tree analysis, and other structured risk tools.
• Collaborate with Quality to ensure that design documentation, Design History Files (DHFs), and updates meet internal standard operating procedures and external regulatory expectations.
• Support manufacturing transfer activities and design changes to ensure robust, compliant, and efficient production processes.
• Contribute to project planning by providing input on schedules, technical risk, design strategies, and key decision points.
• 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, including root cause analysis and implementation of effective solutions.
• Collaborate with Regulatory Affairs to support Notified Body audits, address questions, and contribute to remediation actions 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 in research and development within the medical device industry, working on regulated products.
• Demonstrated experience preparing EU MDR–compliant technical documentation for medical devices intended for the EU market.
• Strong understanding of design controls, including requirements comparable to 21 CFR 820.30, and their application throughout the product lifecycle.
• Hands-on experience working with 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, including preparation and defense of technical documentation.
• Excellent technical writing skills with the ability to produce clear, complete, and audit-ready documentation.
• Ability to plan, execute, and document engineering studies, verification and validation testing, and risk management activities.
• Strong cross-functional collaboration skills, with experience working alongside Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams.

Additional Skills & Qualifications

• Experience working with Class IIb or Class III medical devices.
• Prior involvement in EU Medical Device Directive (MDD) to EU MDR transition projects.
• Experience coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions.
• Familiarity with SolidWorks for mechanical design and Windchill or similar product lifecycle management (PLM) systems.
• Experience applying IEC medical electrical equipment safety requirements to product design and verification.
• Demonstrated ability to lead or support FMEA, fault-tree analysis, and other advanced risk assessment methodologies.
• Strong problem-solving skills and experience leading investigations of design issues, CAPAs, and nonconformances.
• Comfort working in a hybrid environment, balancing hands-on engineering work with documentation and cross-functional collaboration.

Work Environment

This is a hybrid role based in Denver, Colorado, combining remote work with on-site activities. The position requires occasional lab work, device testing, and hands-on engineering activities involving medical devices and related equipment. You will work closely with cross-functional teams in a collaborative R&D environment that emphasizes regulatory compliance, quality, and innovation. The role may involve occasional travel, estimated at less than 10%, for training, team meetings, or coordination with other sites and stakeholders.

Job Type & Location

This is a Permanent position based out of Denver, 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 Jul 24, 2026.