Overall goal of the position:

Oversee manufacturing processes, developmental engineering project deliverables, and responsible for ensuring production of high-quality, Class II and Class III medical devices and components, efficiently and at scale.

Specific Tasks:

• Build and lead a team that works in several areas of the manufacturing and development of medical devices, including manufacturing and engineering personnel.
• Assume high-level oversight and management of production process and ensure all production targets are met in terms of quality, efficiency, and cost.
• Work closely with manufacturing and engineering managers to ensure that the manufacturing process is performed in compliance with relevant regulatory requirements and guidelines.
• Ensure that all production and developmental engineering operations adhere to the company Quality Management System procedures and processes aligned to all regulatory requirements for Class II and Class III medical devices.
• Identify opportunities to optimize process and improve production efficiency by refining process workflow and implementation of new technologies, including automation.
• Risk management responsibilities, including risk identification, mitigation, testing, and validation of solutions.
• Work closely with department managers and executive management to ensure that resources required for operations are availed in a timely manner and allocated according to strategic business priorities.
• Partially responsible for budget planning and financial management of the operation, working in partnership with the executive management in forecasting revenue and cost for capital investments and day-to-day expenditures.

Your background:

• MBA Preferred, BA/BS, in Engineering or related industry required.
• Minimum of 10 years of relevant leadership/management experience.
• Experience working with manufacturing-based technology process and principles required.
• Experience in the medical device industry preferred.
• Experience working with FDA, ISO 13485:2026 / 21CFR part 11 preferred.
• Program or project management experience preferred.
• Sound written and oral communication skills; must be able to write and understand routine reports, follow oral and written instructions, and speak effectively with all levels of the organization.
• Must have ability to handle sensitive and confidential situations and materials.
• Technical understanding of documentation, safety, and design applications required.

Compensation:

• $145,000 to $180,000 annually, depending upon qualifications
• Paid vacation and sick leave; paid holidays
• Partial payment by company of Group Health Insurance
• 401(K) retirement plan with limited company matching

If you are interested, please send your application to our HR department.