Senior Product Systems Engineer (Medical Devices)

Location: Onsite in Devens, Massachusetts, United States

Annual base salary: $100,000–$137,000

Company

hirify.global develops industrially scalable laser metal additive manufacturing and precision machining capabilities for aerospace, defense, medical, and other essential industries.

What you will do

• Design end-to-end product flow through the factory in partnership with operations, quality, digital, and enterprise teams.
• Lead Kaizen events, prioritize bottlenecks, and drive sustained process improvement.
• Define ERP methods-of-manufacture standards and govern customer-specific requirements.
• Own process and quality documentation, configuration control, and revision governance.
• Build process dashboards from MES/ERP data and partner with the digital team on data models.
• Resolve complex process failures through root-cause analysis and corrective action while mentoring product engineers.

Requirements

• Bachelor’s degree in mechanical, materials, manufacturing, biomedical engineering, or a related discipline.
• 5+ years of manufacturing or process engineering experience, preferably including 3+ years in a regulated medical-device environment.
• Experience owning a manufacturing process or value stream at the system level.
• Working knowledge of FDA 21 CFR Part 820, design controls, and IQ/OQ/PQ process validation.
• Deep knowledge of metal additive and subtractive manufacturing processes.
• Experience with MES/ERP reporting or dashboards, such as SQL, Power BI, or Tableau, and cross-functional improvement without direct reporting authority.

Culture & Benefits

• Inclusive culture centered on ownership, quality, curiosity, accountability, and continuous learning.
• Medical, dental, vision, and life insurance.
• Generous paid time off.
• 401(k) plan with company match.
• Competitive salary and equity package.