Remote Medical Device Product Engineer

Actalent; Caledonia (MI); Hybrid; USD 69,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability coverage

Job summary

Actalent in Caledonia, MI is seeking a Product Development Engineer to own sections of design history files for Class I medical devices. The role focuses on regulatory compliance, design optimization for clinical safety, production efficiency, reliability, and cost control.

The position requires a Bachelor's degree in Engineering, experience with Class I Medical Devices, and solid DHF creation skills, plus FMEA and project management experience.

Qualifications

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

Responsibilities

• Execute medical device design history file activities to ensure compliance with regulations.
• Conduct evaluations of medical device designs to meet defined product requirements and optimize for safe clinical solutions, production, reliability, and cost effectiveness.
• Ensure product changes meet regulatory requirements.
• Participate in troubleshooting and problem-solving efforts related to product design.
• Leverage thorough engineering analysis and data throughout the process.
• Review gap analysis with managers and remediate where applicable.
• Remediate both device and packaging with support from company-provided SMEs.
• Engage in Formal Information Collections (FIC) to understand design requirements, involving clinical conversations and reverse engineering of products, with hands-on bench top testing.

Skills

DHF creation

FMEA

Project management

Medical devices experience

Education

Bachelor's degree in Engineering

Job description

Actalent in Caledonia, MI is seeking a Product Development Engineer to own sections of design history files for Class I medical devices. The role focuses on regulatory compliance, design optimization for clinical safety, production efficiency, reliability, and cost control.

The position requires a Bachelor's degree in Engineering, experience with Class I Medical Devices, and solid DHF creation skills, plus FMEA and project management experience.