Engineering Project Manager

Raise; Logan (UT); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Health, dental, and vision benefits

Life insurance

Long-term disability

401(k) plan

Relocation assistance

PTO

Job summary

Raise is seeking an Engineering Project Manager to join a global leader in in-vitro diagnostics in Utah. You will direct, coordinate, and execute engineering projects across design, procurement, testing, and transition to production, working with cross-functional teams and external stakeholders.

The role requires a BS in Engineering, 5–10 years in engineering with 3–5 years in product development leadership, and strong technical writing.

Qualifications

• Bachelor's Degree in Engineering or higher.
• 5–10 years of engineering/technical experience.
• 3–5 years as a project manager for product development.
• Experience with full medical device development cycles.
• Strong technical writing skills.
• Knowledge of ISO 13485 and FDA cGMP is preferred.
• CSM or PMP certification preferred.

Responsibilities

• Plan engineering programs per project requirements and standards.
• Review designs for regulatory compliance and contract requirements.
• Coordinate with internal/external stakeholders throughout design and development.
• Oversee prototyping, testing, and transition to production.
• Document development activities per Quality Systems (design controls, risk management).
• Track budget expenditures and report status to management.
• Lead and motivate cross-functional teams to meet milestones.

Skills

Project leadership

Cross-functional leadership

Technical writing

Regulatory knowledge

Agile methodologies

Education

Bachelor's degree in Engineering

Job description

• Logan, UT
• Full-time, permanent position plus PTO
• 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.

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.

What You Will Be Doing…

• 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

test problems.

• Coordinates with internal and external project stakeholders, as needed, 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.

Why this is the right job for you…

• 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 ScrumMaster (CSM)) in Agile methodologies preferred.
• Project Management Professional (PMP) certification, Certified ScrumMaster (CSM), or equivalent preferred.

Looking for meaningful work? We can help.

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we're a certified B Corporation and donate 10% of our profits to charity.

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 accommodation: https://raise.jobs/accommodations/

In order to submit candidates for roles, our clients will sometimes require personal information to confirm the identity of applicants and their legal status to work. Raise will never ask you for personal or banking information unless you have been selected for a job. If you are ever unsure about the legitimacy of this or another job posting by Raise (or have any other questions), please contact us at [phone] or [e-mail]