Sr Manufacturing Engineer (Medical Devices)

Location: Hayward, California, United States

Salary: $96,000–$132,000 annually, plus potential discretionary bonus.

Company

hirify.global develops healthcare products and technologies focused on its mission to save and sustain lives.

What you will do

• Support manufacturing operations from raw materials through finished medical devices.
• Drive continuous improvement in production performance, product quality, reliability, yield, lead time, and process capability.
• Provide hands-on engineering support for manufacturing equipment, automation, assembly methods, maintenance, and process validation.
• Lead nonconformance investigations, including root cause analysis, CAPA/NCR actions, effectiveness checks, and failure analysis reporting.
• Plan and manage equipment, vendor, contractor, machine installation, and capital projects within operational and budget constraints.
• Maintain engineering, validation, quality, safety, training, and project documentation in compliance with applicable regulations.

Requirements

• Bachelor’s degree in mechanical, biomedical, or electrical engineering.
• Three to five years of maintenance or engineering experience in pharmaceutical or medical device manufacturing.
• Experience with data-driven problem solving, DMAIC, statistical analysis, process validation, PFMEA, and design for manufacturability.
• Knowledge of GMP/GDP, EHS requirements, technical writing, and preparation of validation protocols and reports.
• Strong analytical, organizational, communication, presentation, and technical documentation skills.
• Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience with Minitab or SAS, Microsoft Office Suite, and manufacturing statistical tools.
• Green Belt, Black Belt, or PMP certification.

Culture & Benefits

• Culture centered on courage, trust, collaboration, ownership, and accountability.
• Medical and dental coverage beginning on day one for eligible employees.
• 401(k) retirement plan with company matching and employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Additional benefits include disability and life insurance, educational assistance, commuting benefits, childcare benefits, and employee assistance programs.