Product Engineer

Job Title: Product Engineer

Job Description

The Product Engineer leads a defined portion of design history file creation and remediation for several Class I medical devices, ensuring full compliance with applicable regulations and quality management system requirements. This role focuses on translating clinical and technical insights into robust design inputs, optimizing products for safe clinical use, manufacturability, reliability, and cost effectiveness while supporting risk management and project execution activities.

Responsibilities

• Execute medical device design history file (DHF) activities to ensure compliance with applicable regulations and internal quality management system requirements.
• Create, update, and remediate design history files for Class I medical devices, covering both devices and associated packaging.
• Evaluate medical device designs to confirm they meet defined product requirements and are optimized for safe clinical performance, production efficiency, reliability, and overall cost effectiveness.
• Ensure that product and packaging changes are properly documented and remain compliant with regulatory and quality standards.
• Participate in troubleshooting and problem-solving activities related to product design, including identifying root causes and implementing effective corrective actions.
• Apply thorough engineering analysis and data-driven decision-making throughout the design and remediation process.
• Review gap analyses with leadership and subject matter experts and implement remediation actions where required.
• Collaborate with device and packaging subject matter experts to manage and support DHF and remediation activities.
• Lead or support Formal Information Collections (FIC) to define and refine design requirements, including conducting clinical discussions and reverse engineering of existing products.
• Perform hands-on bench-top testing as part of FIC and verification activities to validate design inputs and confirm product performance.
• Coordinate project activities in alignment with key milestones, including QMS training and ramp-up, DHF creation and remediation, and submission to the technical file team.
• Prepare and finalize documentation for submission to the technical file team, ensuring completeness, accuracy, and regulatory readiness.
• Apply project management practices to plan, track, and deliver assigned work within agreed timelines and quality standards.

Essential Skills

• Bachelor’s degree in Engineering or Bachelor of Science in Engineering.
• Experience working with Class I medical devices, including design history file creation and remediation.
• Demonstrated experience creating and maintaining design history files (DHF) for medical devices.
• Knowledge and hands-on experience with risk management methodologies for medical devices.
• Experience with Failure Mode and Effects Analysis (FMEA) as part of risk management.
• Project management experience in a regulated or technical environment.
• Ability to conduct engineering analysis and interpret data to support design decisions.
• Capability to perform hands-on bench-top testing to support FIC and verification activities.
• Familiarity with quality management systems (QMS) and regulatory expectations for medical device documentation.

Additional Skills & Qualifications

• Experience with Class I medical device remediation projects, particularly involving DHF updates and regulatory alignment.
• Exposure to both device and packaging design considerations within medical device development.
• Comfort engaging in clinical conversations to understand user needs and translate them into design inputs.
• Experience with reverse engineering of products to derive or confirm design requirements.
• Strong documentation skills with attention to detail in technical and regulatory records.
• Ability to collaborate effectively with cross-functional subject matter experts, including device and packaging specialists.

Work Environment

The role offers a primarily remote work arrangement, providing flexibility while maintaining strong collaboration with project teams and subject matter experts. There may be a need for limited on-site work, potentially for a few weeks over the course of the project, to support Formal Information Collections (FIC) and verification testing activities. On-site work will focus on hands-on bench-top testing, collaboration with clinical and technical stakeholders, and execution of verification tasks in a controlled environment. The position operates within a structured quality management system, with clear milestones for training and ramp-up, design history file creation and remediation, and final submission to the technical file team.

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

The pay range for this position is $60.00 - $65.00/hr.

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)

This is a hybrid position in Caledonia,MI.

This position is anticipated to close on Jun 15, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccommodation@actalentservices.com 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.

Salary : $60 - $65