Senior Manufacturing Engineer (Medical Devices)

Location: Onsite in Salt Lake City, Utah, United States

Salary: $100,000–$125,000 annually

Company

hirify.global develops and manufactures products while fostering a performance-driven and collaborative engineering culture.

What you will do

• Provide technical leadership and mentorship to engineers, technicians, and manufacturing personnel.
• Develop, qualify, validate, and optimize manufacturing processes for FDA-regulated medical devices.
• Lead IQ/OQ/PQ validations and support production, quality, regulatory, and new product introduction activities.
• Support CAPA, NCR, and complaint investigations through root cause analysis and corrective actions.
• Design fixtures, tooling, and test equipment, and drive Lean Manufacturing and continuous improvement initiatives.
• Manage capital equipment projects from specification and procurement through implementation and validation.

Requirements

• Bachelor’s degree in an engineering discipline and 7+ years of manufacturing engineering experience.
• 5+ years of experience in FDA-regulated medical device manufacturing preferred.
• Experience leading IQ/OQ/PQ process validations and supporting design transfer and new product introduction.
• Knowledge of FDA QSR/QMSR, ISO 13485, ISO 14971, CAPA, NCR, complaint investigations, and root cause analysis.
• Proficiency with SPC, process capability analysis, Gage R&R, DOE, Minitab, and SolidWorks or equivalent 3D CAD software.
• Strong project management and leadership skills; Six Sigma Green Belt or Black Belt certification is preferred.

Nice to have

• Experience with electromechanical medical devices or cleanroom manufacturing.
• Six Sigma Green Belt or Black Belt certification.

Culture & Benefits

• Onsite work in Salt Lake City with a collaborative and inclusive workplace.
• Annual profit sharing, matching 401(k), employee stock purchase plan, flexible spending accounts, and health savings accounts.
• Flexible paid time off, company holidays, parental leave, and relocation assistance.
• Medical, dental, vision, life, disability, and supplemental benefit coverage.
• Tuition assistance, mentorship, coaching, leadership development, and career growth support.