Product Engineer
Remote / Online - Candidates ideally in
Caledonia, Kent County, Michigan, 49316, USA
Listed on 2026-06-04
Caledonia, Kent County, Michigan, 49316, USA
Listing for:
Actalent
Remote/Work from Home
position Listed on 2026-06-04
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
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.
Job Type & Location
This is a Contract position based out of Caledonia, MI.
Pay and Benefits
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…
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