Remote Medical Device Product Development Engineer

Actalent; United States; Hybrid; USD 69,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Product Development Engineer to own portions of design history file execution for Class 1 Medical Devices. The role emphasizes regulatory compliance, design optimization for safe clinical solutions, production, reliability, and cost effectiveness.

The position supports a primarily remote work arrangement with on‑site testing and occasional on‑site presence in Caledonia, MI. A Bachelor’s degree in Engineering and experience with DHF, FMEA, and risk management are required.

Qualifications

• Bachelor's degree in Engineering.
• Experience with Class I Medical Devices.
• Proficiency in creating design history files.
• Experience in risk management and FMEA.
• Project management experience.

Responsibilities

• Execute design history file activities to ensure regulatory compliance.
• Evaluate medical device designs to meet product requirements and optimize for safety, production, reliability, and cost.
• Ensure product changes meet regulatory requirements.
• Troubleshoot and solve design-related issues.
• Use engineering analysis and data throughout the process.
• Review gap analyses and remediate with SMEs.
• Engage in FIC to understand design requirements with bench testing.

Skills

DHF creation

FMEA

Risk management

Project management

Education

Bachelor's degree in Engineering

Job description

Actalent is seeking a Product Development Engineer to own portions of design history file execution for Class 1 Medical Devices. The role emphasizes regulatory compliance, design optimization for safe clinical solutions, production, reliability, and cost effectiveness.

The position supports a primarily remote work arrangement with on‑site testing and occasional on‑site presence in Caledonia, MI. A Bachelor’s degree in Engineering and experience with DHF, FMEA, and risk management are required.