Engineering Project Manager

Engineering Project Manager

Location:

Logan, UT – Full‑time, permanent with PTO.

Our client is a global leader in in‑vitro diagnostics, serving hospitals and labs in over 100 countries with a comprehensive range of diagnostic products and solutions.

The Engineering Project Manager directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering projects within the assigned responsibility area. The role may provide technical assistance across design, procurement, construction, and testing of experimental models and prototypes, and may act as lead on significant projects.

• Plan and formulate engineering programs according to project requirements and company standards.
• Review product design for compliance with engineering principles, company standards, applicable regulatory standards
  , customer contract requirements, and related specifications.
• Coordinate technical developments, scheduling, and resolution of engineering design and test problems.
• Coordinate with internal and external stakeholders throughout the design and development process, including transition to production.
• Design, execute, and document experiments and test protocols to verify that designs meet input requirements and validate intended use.
• Coordinate and review the selection of prototyping approaches and methods to produce components or subsystems that meet overall project needs and milestones.
• Review recommendations from project staff regarding manufacturing methods and supplier selection based on project needs, requirements, and company standards.
• Direct and coordinate prototype or pilot‑run procurement activities within engineering and with purchasing and operations.
• Write and review documentation of development activities in accordance with formal Quality Systems (e.g., ISO 13485, ISO 14971).
• Track and control expenditures within project budget limits.
• Communicate project status, major issues, and mitigations to stakeholders, engineering management, and executive management.
• Assist 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 engineering/technical experience, including 3–5 years of managing product development projects.
• Experience with full medical device product development cycles, including customer and engineering requirements.
• Strong technical writing skills.
• Detail‑oriented approach to design, strategy, and documentation.
• Experience developing documentation within design controls of ISO 13485 and FDA cGMP regulations, including ISO 14971 for product risk management.
• Certification or experience in Agile methodologies (e.g., Certified Scrum Master) preferred.
• Project Management Professional (PMP) or equivalent certification preferred.

• Health, dental, and vision benefits.
• Life insurance and long‑term disability coverage.
• 401(k) plan.
• Relocation assistance.
• Paid time off (PTO).

We encourage all qualified applicants, including those from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, LGBTQ+ individuals, veterans, and people with visible or non‑visible disabilities, to apply.