Manufacturing Engineer (Medical Devices)

Location: Onsite in Acton, Massachusetts, United States; travel estimated at 30–40%.

Annual base salary: $76,400–$114,575, plus potential incentive compensation.

Company

hirify.global develops the Omnipod wearable insulin delivery platform and other medical device technologies for people with diabetes and related conditions.

What you will do

• Lead continuous improvement initiatives for high-volume manufacturing processes and equipment.
• Support installation and upgrades of manufacturing equipment and new component introductions.
• Monitor manufacturing KPIs and implement improvements to efficiency, quality, and cost.
• Conduct structured root cause investigations using DMAIC, DMADV, Fishbone, and other problem-solving tools.
• Develop and execute IQ, OQ, TMV, CSV, and PQ validation protocols and reports.
• Collaborate with Maintenance, Equipment Design, Controls, Operations, and Quality teams while maintaining compliant process documentation.

Requirements

• Experience in a highly automated, high-volume manufacturing environment.
• Knowledge of statistical analysis, SPC, DOE, root cause analysis, and validation techniques.
• Ability to troubleshoot semi-automated and fully automated mechanical equipment.
• Working knowledge of CAD design and print reading; SolidWorks preferred.
• Proficiency with Microsoft Word, Excel, and PowerPoint; familiarity with Minitab or JMP preferred.
• High school diploma with 7+ years of engineering experience, or a bachelor's degree with 2+ years of experience, or an M.S. in Engineering or Engineering Management with 0–2 years of experience.

Nice to have

• Medical device industry experience.
• High-volume manufacturing or automation experience.
• Knowledge of injection molding, stamping, springs, CNC milling, or CNC turning.

Culture & Benefits

• In-person work at the Acton manufacturing location.
• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off and employee wellness programs.
• Work in a regulated Class II medical device environment under cGMP, FDA, and ISO guidelines.