Product Development Engineer

Actalent; Caledonia (MI); Hybrid; USD 69.000 - 83.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) retirement plan

Life Insurance

Disability coverage

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

DHF creation

FMEA

Project management

Medical devices experience

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

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).

Job Type & Location

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

Application Deadline

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

Workplace Type

This is a hybrid position in Caledonia,MI.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.