Medical Device R&D Engineer — FDA Design Controls

Actalent; Aurora (CO); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Critical Illness

Accident

Hospital

401(k) Retirement Plan

Life Insurance

Short And Long-term Disability

Health Spending Account (HSA)

Transportation Benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent is seeking a lead remediation design engineer to drive remediation design activities and technical documentation for medical devices, ensuring FDA and ISO compliance. You will collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.

The role requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry, plus strong expertise in FDA design controls,

Qualifications

• Requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry.
• Must have strong expertise in FDA design controls, risk management tools like FMEA, and proficiency in SolidWorks.

Responsibilities

• Lead remediation design activities and technical documentation for medical devices to ensure compliance with FDA and ISO standards.
• Collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.

Skills

FDA Design Controls

Medical Device Design

Risk Management

FMEA

Verification And Validation

Technical Writing

SolidWorks

Windchill

ISO Standards

CAPA

Design History Files

Fault-tree Analysis

Education

Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering

Tools

SolidWorks

Windchill

Job description

Actalent is seeking a lead remediation design engineer to drive remediation design activities and technical documentation for medical devices, ensuring FDA and ISO compliance. You will collaborate cross-functionally to execute verification and validation testing and manage product risk assessments.

The role requires a Bachelor's or Master's degree in Mechanical, Biomedical, or Electrical Engineering with R&D experience in the medical device industry, plus strong expertise in FDA design controls,