Engineering Project Manager

About the role

Our client is a global leader in in-vitro diagnostics, serving hospitals and labs in over 100 countries and manufacturing 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 area, providing technical assistance in design, procurement, construction, and testing of experimental models and prototypes, and may act as lead on projects.

Responsibilities

• 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 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 designs meet input requirements and validate intended use.
• Coordinates and reviews selection of prototyping approaches and methods to produce components or subsystems to meet project needs and milestones.
• 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 within engineering and with purchasing and operations.
• Writes, reviews, and approves documentation of development activities consistent with formal Quality Systems, including definition of product requirements, project planning, design output, design review, design verification and validation, control of design changes, and risk management.
• Tracks and controls expenditures within project budget.
• Communicates project status, major issues/mitigations to stakeholders, engineering management, and executive management.
• Assists with related special projects as required.

Requirements

• 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.
• Experience with one or more full medical device product development cycles, including 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) in Agile methodologies preferred.
• Project Management Professional (PMP) certification, Certified ScrumMaster (CSM), or equivalent preferred.

Benefits