Med Device Design Controls Engineer

Actalent; Centennial (CO); On-site; USD 48,000 - 80,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Time Off (PTO)

Job summary

Actalent seeks a Mechanical Engineer with FDA design controls expertise for medical devices intended for the US market. You will design, document, and align product development with regulatory obligations across lifecycle stages.

The role requires strong technical writing, risk management, and collaboration with Regulatory Affairs, QA, Clinical, and Manufacturing teams in an onsite Denver/CO environment.

Qualifications

• Experience in R&D within the medical device industry with product design involvement.
• Strong knowledge of FDA design controls and ISO/IEC standards related to the product type.
• Ability to generate audit-ready documentation including DHFs, risk analyses, and V&V reports.
• Excellent technical writing skills for clear, compliant documentation.
• Hands-on experience with risk management activities such as FMEA.

Responsibilities

• Lead remediation design activities for medical devices per FDA design control.
• Conduct studies, testing, and evaluations to align with regulatory requirements.
• Generate design inputs/outputs, risk analyses, V&V protocols and reports.
• Maintain risk management activities per ISO standards.
• Lead CAPA investigations and support cross-functional teams.
• Collaborate with Regulatory, QA, Clinical, and Manufacturing teams.

Skills

Regulatory collaboration

FDA design controls

Technical writing

Risk management

Cross-functional teamwork

Problem solving

Education

Bachelor's or Master's in Mechanical, Biomedical, Electrical engineering

Tools

SolidWorks

Windchill PLM

Job description

Actalent seeks a Mechanical Engineer with FDA design controls expertise for medical devices intended for the US market. You will design, document, and align product development with regulatory obligations across lifecycle stages.

The role requires strong technical writing, risk management, and collaboration with Regulatory Affairs, QA, Clinical, and Manufacturing teams in an onsite Denver/CO environment.