Principal Equipment Engineer (Medtech)

TL;DR

Principal Equipment Engineer (Medtech): Driving the strategic direction of manufacturing equipment design, procurement, and qualification for new combination devices with an accent on automation standards and regulatory compliance. Focus on developing scalable equipment specifications, leading qualification activities, and managing external automation vendors.

Location: Onsite in Fridley, Minnesota, USA (minimum 5 days a week)

Salary: $128,800 - $193,200 USD

Company

hirify.global is a global healthcare technology leader focused on alleviating pain, restoring health, and extending life through engineering innovation.

What you will do

• Define and drive the strategic direction for equipment engineering standards and best practices across multiple product lines.
• Lead the development of detailed, scalable Equipment Specifications aligned with manufacturing strategy and regulatory requirements.
• Oversee equipment qualification activities, including test method validation and equipment characterization.
• Manage large, complex projects and serve as the primary technical contact for internal and external stakeholders.
• Collaborate with Engineering during early design phases to provide strategic input for manufacturing automation.
• Coach and mentor junior engineers to elevate the overall technical capability of the Advanced Manufacturing Engineering team.

Requirements

• Bachelor's degree with 7+ years of experience, Master's with 5+ years, or PhD with 3+ years of relevant experience.
• Must be based in or have authorization to work in the USA (Sponsorship is offered exclusively for Principal-level roles).
• Proven experience in equipment engineering and manufacturing automation.
• Experience managing equipment governance reviews and procurement lifecycles.
• Ability to work onsite in Fridley, MN full-time.

Nice to have

• Extensive experience in regulated environments such as FDA or ISO 13485.
• Proficiency with CAD software (SolidWorks, Creo) and additive manufacturing (SLA, FDM).
• Deep experience with URS, FDS, GAMP5, and compliance systems.
• Strong negotiation skills and experience managing external automation vendors end-to-end.

Culture & Benefits

• Competitive salary with the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• Retirement security via a 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Professional growth support through tuition assistance and the Simple Steps well-being program.