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Manager Medical Device Operations Jobs in Massachusetts

... operational readiness. * Mentor and support engineering staff development while fostering a high ... Medical Device or related industry. * 6+years' experience in Project/Program Management in a ...

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Medical Device Assembler

Westford, MA · On-site

$21.51/hr

  • Medical

  • Dental

  • Vision

MEDICAL DEVICE ASSEMBLER Westford, MA | $21.50/Hour | 1st Shift | Monday-Thursday * $21.50 per hour ... Perform casting and coating operations as required. Use microscopes and precision hand tools to ...

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Territory Sales Manager Medical Device Boston

Boston, MA · On-site

$120 - $160/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Overview AngioSafe is a Bay Area medical device company focusing on improving healthcare delivery ... We seek Territory Field Managers to drive and support the commercialization of our innovative ...

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Manager Medical Device Operations information

What is a manager medical device operations?

A Manager Medical Device Operations oversees the daily activities and processes involved in manufacturing, distributing, and maintaining medical devices. They ensure that operations comply with regulatory standards, manage teams, and work to optimize efficiency, quality, and safety. This role often involves coordinating with other departments, handling audits, and implementing process improvements to meet organizational goals. They play a critical role in ensuring that medical devices reach healthcare providers and patients safely and on time.

What are some common challenges faced by a manager medical device operations, and how can they be addressed?

Managers in Medical Device Operations often face challenges such as ensuring compliance with strict regulatory standards, coordinating cross-functional teams, and managing supply chain complexities. Staying proactive with regulatory updates, fostering open communication among departments, and implementing robust quality management systems can help address these issues. Additionally, investing in staff training and process improvement initiatives can streamline operations and minimize delays or compliance risks.

What are the key skills and qualifications needed to thrive as a manager medical device operations?

To excel as a Manager Medical Device Operations, you need expertise in supply chain management, regulatory compliance (such as FDA and ISO standards), and operational leadership, typically supported by a bachelor’s degree in engineering, life sciences, or business. Familiarity with ERP systems, quality management software, and relevant certifications like Six Sigma or PMP are commonly required. Strong communication, problem-solving, and team leadership skills help drive cross-functional collaboration and continuous improvement. These competencies are essential for ensuring product quality, regulatory adherence, and efficient operations in a highly regulated industry.

What are popular job titles related to Manager Medical Device Operations jobs in Massachusetts?

For Manager Medical Device Operations jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Operations jobs in Massachusetts look for?

The top searched job categories for Manager Medical Device Operations jobs in Massachusetts are:

Medical Device - Operations Manager - Burlington, MA

Michael Page USA

Burlington, MA • On-site

Other

Posted 4 days ago


Job description

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.