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

Job Title: Product Development Engineer

Job Description

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Job Type & Location

This is a Contract position based out of Caledonia, MI.

Pay and 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.

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. If eligible, the benefits available for this temporary role may include the following:

• 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)

Application Deadline

This position is anticipated to close on Oct 26, 2026.

Workplace Type

This is a hybrid position in Caledonia,MI.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.