Senior Operations Manager - Medical Device - Burlington, MA

Michael Page International

Burlington, Massachusetts

JOB DETAILS
SALARY
$150,000–$185,000 Per Year
JOB TYPE
Full-time
SKILLS
Alliance/Partner Management, Analysis Skills, Asset Management, Budgeting, Business Growth, Business Operations, Business Support, Compensation and Benefits, Continuous Improvement, Contract Management, Contract Manufacturing, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, ERP (Enterprise Resource Planning), Energy Efficiency, FDA Requirements, Facilities Management, ISO (International Organization for Standardization), Leadership, Lean Manufacturing, MPI, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Manufacturing Requirements, Manufacturing/Industrial Processes, Manufacturing/Production Testing, Matrix Management, Medical Equipment, Medical Organizations, Metrics, NetSuite, Operational Audit, Operational Improvement, Operational Strategy, Operational Support, Operations, Operations Management, Operations Planning, Organizational Skills, Performance Metrics, Problem Solving Skills, Product Support, Product/Service Launch, Production Schedule, Production Support, Project/Program Management, Quality System Requirements (QSR), Regulations, Research & Development (R&D), Resource Utilization, Safety/Work Safety, State Laws and Regulations, Strategic Planning, Supply Chain, Systems Scalability, Team Lead/Manager, Team Player, Trend Analysis, Vendor/Supplier Management
LOCATION
Burlington, Massachusetts
POSTED
4 days ago
Senior Operations ManagerMy client is an innovative medical device company focused on delivering high-quality products within a regulated manufacturing environment. The organization is experiencing growth and seeks a hands-on operational leader to drive manufacturing excellence, strengthen contract manufacturing partnerships, and support commercial expansion.Job DescriptionLead daily manufacturing operations across internal production, contract manufacturing, production testing, depot repair, field asset management, and facilities. Manage contract manufacturing relationships, ensuring schedule attainment, product quality, responsiveness, and delivery performance. Develop and monitor KPIs related to safety, quality, delivery, productivity, inventory, and operational performance. Drive operational excellence, continuous improvement, and Lean Manufacturing initiatives across the organization. Establish scalable systems, processes, and governance to support business growth and operational efficiency. Partner with Supply Chain, Engineering, Quality, Regulatory, Service, and R&D teams to support product launches, manufacturing transfers, and sustaining operations. Ensure compliance with ISO 13485, FDA Quality System Regulations, MDSAP, EU MDR, and company quality system requirements. Lead daily operational reviews, GEMBA walks, and cross-functional communication activities. Support production readiness, material availability, customer requirements, and production schedule adherence. Drive issue resolution and corrective actions related to manufacturing, quality, supplier, and operational challenges. Analyze operational data and business metrics to support data-driven decision-making. Develop and improve operational workflows, manufacturing efficiency, and resource utilization. Support budget objectives, operational planning, and strategic initiatives in partnership with senior leadership. Assist with product complaint investigations, trend analysis, and operational support activities when needed. Provide hands-on leadership and support on the manufacturing floor to meet customer and business commitments.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.The Successful ApplicantA successful Senior Operations Manager should have:Bachelor's degree in a technical, scientific, engineering, or related discipline.5+ years of medical device manufacturing leadership experience.Experience managing operations within an ISO 13485-regulated environment.Strong knowledge of FDA Quality System Regulations, MDSAP, and medical device manufacturing requirements.Working knowledge of Design Controls, DHF, DMR, DHR, and CAPA processes.Experience leading contract manufacturing and supplier management activities.Strong background in Lean Manufacturing and continuous improvement methodologies.Experience with ERP systems such as NetSuite or similar platforms.Strong project management, communication, and leadership skills.Proven ability to drive results in fast-paced, highly regulated environments.Excellent analytical, organizational, and problem-solving abilities.Ability to lead cross-functional teams within a matrixed organization.What's on OfferHigh-impact leadership role within a growing medical device company.Opportunity to shape operational strategy and scalable manufacturing processes.Exposure to new product introductions, manufacturing transfers, and commercial growth initiatives.Collaborative leadership team and mission-driven culture.Strong career advancement potential.Competitive compensation and benefits package.If you are looking to take the next step in your career with an innovative medical device manufacturing organization, apply today for immediate consideration!

About the Company

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Michael Page International

Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job. In Canada, we focus on recruiting for the following areas: Banking and financial services Digital and e-commerce Engineering and manufacturing Finance and accounting Human resources Information technology Marketing Oil and gas Procurement and supply chain Property and construction Sales An Established Brand The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry. A Market Leader The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world. Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.michaelpage.ca/