Mechanical Engineer Design Controls

Job Title: Mechanical Engineer (Design Controls)
Location: Denver, CO
Duration: Long Term

Job Description
We are seeking an experienced Mechanical Engineer with expertise in FDA design controls to support the design, documentation, and compliance strategy for medical devices intended for the US market. In this role, you will apply a strong engineering foundation and hands-on experience with design requirements across the full product lifecycle. You will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams 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 FDA design control requirements and applicable standards.
• Conduct engineering studies, testing, and technical evaluations to ensure design controls are fully aligned with regulatory requirements.
• Generate comprehensive technical documentation, including design inputs and outputs, risk analyses, verification and validation protocols, and test reports.
• Perform and maintain risk management activities in alignment with relevant ISO risk management standards.
• Lead or support FMEA, fault-tree analysis, and other risk assessment tools to identify, evaluate, and mitigate product risks.
• Collaborate with Quality teams to ensure design documentation, design history files (DHFs), and updates meet internal standard operating procedures and external regulatory standards.
• Contribute to project planning by supporting schedule development, resource estimation, and technical decision making throughout the project lifecycle.
• 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 other global regions.
• Work cross-functionally with Regulatory, Clinical, Manufacturing, and Quality to ensure seamless integration of design changes and compliance activities into ongoing development and production.

Essential Skills

• Bachelor's or Master's degree in Mechanical, Biomedical, Electrical, or a related engineering field.
• Experience in R&D within the medical device industry, with direct involvement in product design and development.
• Strong understanding of design controls per FDA requirements and relevant ISO and IEC/ISO standards related to the product type.
• Proven ability to conduct engineering studies, testing, and technical evaluations in a regulated environment.
• Demonstrated experience generating audit-ready documentation, including design inputs and outputs, risk analyses, and V&V protocols and reports.
• Excellent technical writing skills with the ability to produce clear, accurate, and compliant documentation.
• Hands-on experience with risk management activities such as FMEA and fault-tree analysis for medical devices.
• Ability to collaborate effectively with cross-functional teams including Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing.
• Strong problem-solving skills with the ability to investigate design issues and support CAPA activities.