Principal Engineer, OpEx (Medical Devices)

Location: Skaneateles, New York, United States; onsite role. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Estimated base salary: $112,000–$154,000 annually, with potential eligibility for discretionary bonuses.

Company

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

What you will do

• Lead continuous improvement initiatives across manufacturing and operational processes to improve efficiency, reduce waste, and enhance product quality.
• Develop and implement Lean, Six Sigma, Lean Daily Management System, and other OpEx methodologies.
• Manage OpEx projects from inception through completion, defining scope, measurable goals, timelines, and alignment with business objectives.
• Analyze operational data and performance metrics, identify trends and root causes, and report results to senior management and stakeholders.
• Train and mentor employees, and lead workshops and Kaizen events focused on problem-solving and process improvement.
• Collaborate with engineering, quality assurance, production, regulatory affairs, and other departments to integrate improvements and maintain compliance with FDA, ISO 13485, GMP, EHS, and other applicable requirements.

Requirements

• Bachelor’s degree in engineering, Industrial Engineering, or Manufacturing; a master’s degree is preferred.
• 7+ years of experience in continuous improvement, process engineering, or operations management, preferably in the medical device or healthcare industry.
• Strong expertise in Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
• Excellent analytical and problem-solving skills with a data-driven approach to decision-making.
• Strong project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.
• Excellent verbal and written communication skills, with the ability to influence and engage stakeholders at all levels.

Nice to have

• Lean Six Sigma Black Belt, Master Black Belt, or equivalent certification.
• Experience with quality management systems and regulatory requirements in the medical device industry.
• Familiarity with statistical analysis software and tools such as Minitab or JMP.

Culture & Benefits

• Culture centered on courage, trust, collaboration, ownership, and accountability.
• Medical and dental coverage starting on day one, plus life, disability, and business travel accident insurance.
• 401(k) retirement savings plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
• Educational assistance, paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Additional commuting, childcare, employee discount, and employee assistance benefits.