Senior Process / Operations Engineer (Medical Devices)

TL;DR

Senior Process / Operations Engineer (Medical Devices): Overseeing contract manufacturing operations for Class II FDA-regulated medical devices with an accent on CMO management, process validation, and regulatory compliance. Focus on scaling manufacturing processes, leading root cause investigations (CAPA), and ensuring strict adherence to FDA and ISO standards.

Location: On-site in Minnetonka, Minnesota

Salary: $130k – $150k

Company

hirify.global is a leading health and wellness platform redefining healthcare by providing personalized, affordable, and accessible care.

What you will do

• Serve as the primary technical operations lead for external contract manufacturers (CMOs) and critical suppliers.
• Develop, optimize, and sustain manufacturing processes for Class II medical devices and consumables.
• Support process characterization and validation activities, including IQ/OQ/PQ and equipment qualification.
• Ensure all manufacturing activities comply with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Collaborate with R&D for design transfer and partner with Supply Chain for production scheduling and inventory management.
• Drive operational excellence using Lean and Six Sigma methodologies to improve yield and reduce costs.

Requirements

• Bachelor's degree in Mechanical, Biomedical, Industrial, Manufacturing, or related Engineering field.
• 8+ years of experience in process or manufacturing engineering within the medical device or diagnostics industry.
• Proven experience managing Contract Manufacturing Organizations (CMOs) and supporting Class II FDA-regulated devices in a GMP environment.
• Deep understanding of Design controls, Process validation (IQ/OQ/PQ), and CAPA/change control systems.
• Must be based in or able to work on-site in Minnetonka, MN.
• Ability to meet physical requirements, including lifting up to 50lbs and wearing respiratory protection/PPE.

Culture & Benefits

• Competitive salary with equity compensation and 401k employer matching.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive medical, dental, vision, and parental leave benefits.
• Employee Stock Purchase Program (ESPP) and discounts on company products.
• Regular offsite team retreats.