Sr Project Engineer (Medical Devices)

Location: Acton, Massachusetts, United States; hybrid arrangement with required on-site work at an hirify.global office. Travel to supplier sites approximately 10–15% of the time is required.

Company

hirify.global develops medical devices and insulin delivery technologies, including the Omnipod product platform, for people with diabetes and other conditions.

What you will do

• Lead supplier tooling and capital equipment qualification projects from project kick-off through implementation and full production.
• Own project schedules, budgets, status reporting, risks, and mitigation plans.
• Partner with R&D, Quality, Automation, Manufacturing, Sourcing, and Purchasing on design-for-manufacturability and supplier projects.
• Author or review supplier validation and qualification protocols, including execution, data analysis, and final reporting.
• Lead procurement, installation, start-up, prototype builds, and qualification runs for manufacturing equipment at global suppliers.
• Investigate supplier quality issues and lead corrective and preventive actions through closure.

Requirements

• Bachelor of Science in Engineering, such as Plastics, Mechanical, Biomedical, Manufacturing, or Industrial Engineering, or a related field.
• Five to seven years of experience with manufacturing processes such as assembly, automation, molding, stamping, electronics, or machining.
• Experience managing supplier tooling projects from concept to production and authoring or overseeing IQ, OQ, and PQ protocols.
• Working expertise in PFMEA, control plans, and Measurement System Analysis.
• Strong written and verbal communication skills, with the ability to influence without direct authority.
• Ability to work on site at an hirify.global office in Acton, Massachusetts and travel to supplier sites approximately 10–15% of the time.

Nice to have

• Experience working directly for a direct-material supplier as an engineer or project manager.
• Experience in a regulated industry, especially medical devices.
• Six Sigma or Lean process improvement experience or certification.
• PMI project management certification.
• Experience with Microsoft Office, Smartsheet, or Excel.

Culture & Benefits

• Hybrid working arrangement with required on-site work at an hirify.global office.
• Cross-functional collaboration across engineering, manufacturing, quality, sourcing, and supplier organizations.
• Exposure to global suppliers and projects involving prototype builds, tooling, equipment installation, and qualification.
• Full-time employment with a medical-device company focused on simplifying insulin delivery.