Engineering Project Manager

Summary

The Engineering PM directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering projects within the area of assigned responsibility. You may provide technical assistance in the areas of design, procurement of materials, construction and testing of experimental models and prototypes. Work is broad in nature and may have overall project responsibility. May act as lead on projects.

• Plans and formulates engineering program according to project requirements and company standards.
• Reviews product design for compliance with engineering principles, company standards, applicable regulatory standards, customer contract requirements, and related specifications.
• Coordinates activities concerned with technical developments, scheduling, and resolving engineering design and testing problems.
• Coordinates with internal and external project stakeholders throughout the design and development process, including transition to production.
• Performs and/or coordinates the design, execution, and documentation of experiments and test protocols to verify that designs of products or subsystems meet input requirements and to validate that the product or subsystem meets the intended use.
• Coordinates and reviews the selection of prototyping approaches and methods to produce components or subsystems to best meet overall project needs and milestones, such as for testing, evaluation for tooling release, trade shows, etc.
• Reviews recommendations from project staff regarding manufacturing methods and supplier selection based on project needs and company standards.
• Directs and coordinates prototype or pilot-run procurement activities both within engineering and with other stakeholders such as purchasing and operations.
• Writes and/or reviews and approves documentation of development activities consistent with formal Quality Systems, including definition of product requirements, project planning, design output (production drawings, bills of materials, procedures, specifications, inspection criteria, etc.), design review, design verification and validation, control of design changes, and risk management.
• Tracks and controls expenditures within limitation of project budget.
• Communicates project status, major issues/mitigations, etc. to other project stakeholders, engineering management, and executive management.
• Assists with related special projects, as required.

• Bachelor’s Degree or higher in Engineering (Mechanical, Biomedical, Electrical, etc.) or a relevant technical field.
• 5-10 years of experience in engineering/technical roles, with 3-5 years of experience managing product development projects, demonstrating the ability to motivate and lead cross-functional teams.
• Experience with one or more full medical device product development cycles, including the development of customer and engineering requirements.
• Strong technical writing skills.
• Detail-oriented approach to design, strategy, and documentation.
• Experience working and developing documentation within design controls of ISO 13485 Quality Management Systems and under FDA cGMP regulations, including ISO 14971 for product risk management.
• Experience or certification (e.g., Certified Scrum Master (CSM)) in Agile methodologies preferred.
• Project Management Professional (PMP), Certified Scrum Master (CSM), or equivalent preferred.

Logan, UT – Fulltime, permanent position plus PTO, Life insurance, long term disability, 401k plan, Health, dental, vision benefits available, RELOCATION ASSISTANCE AVAILABLE.

Our client is a global leader in in‑vitro diagnostics, serving hospitals and labs in over 100 countries. This role offers the opportunity to live in Utah with access to mountains, hiking, fishing, and more.

We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/non‑visible disabilities. We have a dedicated webpage for accommodations:
Accommodations.