Product Development Engineer
About the role
The Product Development Engineer will be responsible for owning a section of the execution of design history files for several Class 1 Medical Devices. The role involves ensuring compliance with applicable regulations and optimizing designs for safe clinical solutions, production, reliability, and overall cost effectiveness.
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.
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.
- Class 1 Medical Device Remediation experience.
Work environment
The work environment can be primarily remote, with occasional on-site requirements to support Formal Information Collections (FIC) and Verification testing. The role involves a structured project timeline with specific milestones, including training, DHF creation/remediation, and submission.
Pay & Benefits
The pay range for this position is $50.00 - $60.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan (Pre-tax and Roth post-tax contributions available)
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.
Job details
- Contract position
- Hybrid workplace in Caledonia, MI
- Anticipated closing date: Oct 26, 2026