Biomedical Engineering Project Lead - Assistance

Engineering Project Manager

Location:

Logan, UT

Full-time, permanent position plus PTO

Benefits:
Health, dental, and vision benefits available;
Life insurance, long-term disability, 401k plan

Relocation assistance available

Our client is a global leader in in‑vitro diagnostics. They strongly serve hospitals and labs in over 100 countries, manufacturing a comprehensive range of diagnostic products and solutions. We are looking for an Engineering Project Manager to join their team in Utah right away. If you have experience in coordinating, planning, organizing and completing engineering projects, this is a great opportunity to get rid of the commute and live where mountains, hiking, fishing and more are right outside your doorstep.

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 concerning technical developments, scheduling, and resolving engineering design and test 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 requirements as well as 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) certification, Certified Scrum Master (CSM), or equivalent preferred.

We strive to build teams that reflect the diversity of the communities we work in. 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/nonvisible disabilities.

We have a dedicated webpage for accommodations where you can learn more about what we offer and request an accommodation.