Medical Device - Operations Manager - Burlington, MA

Our client is seeking a Senior Operations Manager to lead day-to-day manufacturing operations and support the continued growth of a medical technology organization. Reporting directly to the Vice President of Operations, this individual will be responsible for ensuring operational execution, production readiness, schedule attainment, quality performance, and customer delivery commitments across both internal manufacturing and external manufacturing partners.

Client Details

Our client is an innovative medical device organization focused on developing and delivering advanced healthcare solutions. The company is experiencing continued growth and is investing in operational infrastructure, manufacturing scalability, and process excellence to support expanding commercial demand.

Description

Responsibilities:

• Lead daily manufacturing operations across production, testing, repair, logistics, and facilities.
• Manage relationships and performance of external contract manufacturing partners.
• Establish and monitor KPIs to drive operational performance and accountability.
• Ensure production schedules, quality standards, and customer delivery requirements are consistently achieved.
• Partner closely with Supply Chain, Quality, Regulatory, Engineering, Service, and R&D teams.
• Support new product introductions, manufacturing transfers, and sustaining operations.
• Drive Lean Manufacturing and continuous improvement initiatives to improve efficiency and productivity.
• Maintain compliance with ISO 13485, FDA Quality System Regulations, MDSAP, and applicable regulatory requirements.
• Lead operational problem-solving efforts and drive timely resolution of production-related issues.
• Develop scalable operational systems, processes, and governance to support business growth.

Profile

Ideal Candidate:

• Bachelor's degree in Engineering, Life Sciences, Operations, or a related technical field.
• 5+ years of leadership experience within medical device manufacturing.
• Strong understanding of ISO 13485, FDA QSR, CAPA, DHF, DMR, and DHR requirements.
• Experience managing both internal manufacturing operations and contract manufacturers.
• Demonstrated success implementing Lean Manufacturing and continuous improvement programs.
• Experience utilizing ERP systems and operational reporting tools.
• Proven ability to lead cross-functional teams in a fast-paced, highly regulated environment.
• Strong analytical, communication, and project management skills.

Job Offer

What's To Offer:

• Competitive base salary and bonus opportunity.
• Opportunity to influence operational strategy and organizational growth.
• Highly visible leadership position reporting directly to executive leadership.
• Collaborative and mission-driven culture.
• Exposure to product launches, manufacturing scale-up initiatives, and strategic operational improvements.
• Comprehensive benefits package and long-term career advancement opportunities.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.