Sr Maintenance Engineer (Medical Devices)

Location: Hayward, California, United States; on-site role

Salary: $96,000–$132,000 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions with a mission to save and sustain lives.

What you will do

• Design, maintain, troubleshoot, and optimize critical systems, infrastructure, utilities, automation, manufacturing equipment, and processes.
• Support production and maintenance teams with equipment performance improvement, process improvements, and technical problem-solving.
• Plan and oversee capital projects, including equipment specifications, budgeting, vendor coordination, and negotiations.
• Lead CAPA and NCR investigations, identify root causes, define corrective and preventive actions, and monitor resolution effectiveness.
• Develop and execute engineering documentation, commissioning, qualification, validation, PFMEA, and Master Validation Plan activities.
• Maintain manufacturing documentation and support compliance with GMP, safety requirements, and California and federal EPA regulations.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or a related field.
• 3–5 years of experience in maintenance, facilities, or engineering within pharmaceutical or medical device manufacturing.
• Experience authoring and executing engineering tests and validation protocols for manufacturing processes, equipment, and utilities.
• Strong problem-solving, analytical, organizational, communication, documentation, and critical-thinking skills.
• Experience with manufacturing systems and Microsoft Office Suite, including strong cGDP documentation practices.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience with statistical analysis using Minitab, SPC, SQC, or DOE.
• Green Belt, Black Belt, or PMP certification.
• Experience applying lean principles and data-driven DMAIC methodologies.

Culture & Benefits

• Culture focused on courage, trust, collaboration, accountability, and meaningful impact in healthcare.
• Medical and dental coverage beginning on day one, plus life, disability, and business travel accident insurance.
• 401(k) retirement savings plan with company matching and an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on tenure, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.