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Medical Device Operations Jobs in Massachusetts (NOW HIRING)

GSK

Associate Director, Device Lead

Waltham, MA · On-site

FDA 21 CFR 820, (EU) 2017/745, Medical Device Regulation (MDR), ISO 13485, ISO 14971, and ISO 10993 ... engineering and operational disciplines. * Strong verbal and written communication skills.

Instylla

Vice President of Operations

Bedford, MA

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on ... Operational Leadership * Build scalable operational frameworks that support rapid growth and ...

Instylla

Vice President of Operations

Bedford, MA · On-site

$200K - $260K/yr

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on ... Operational Leadership * Build scalable operational frameworks that support rapid growth and ...

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Medical Device Operations information

What is medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in medical device operations?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.

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

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are the most commonly searched types of Medical Device Operations jobs in Massachusetts?

The most popular types of Medical Device Operations jobs in Massachusetts are:

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

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

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

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

What cities in Massachusetts are hiring for Medical Device Operations jobs?

Cities in Massachusetts with the most Medical Device Operations job openings:

Medical Device Operations jobs near you
Infographic showing various Medical Device Operations job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 16% Part Time, 1% Temporary, 6% Contract, and 1% Nights. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution.

Senior Software Project Manager - Medical Device #3065- Marlborough, MA

Theuniversityunion

Marlborough, MA • On-site

$120 - $150/hr

Other

Posted 18 days ago

Key responsibilities

  • Manage Manufacturing Software and Sourced Finished Medical Device software-related workstreams within a medical device integration program.

  • Coordinate requirements, validation, release planning, and production readiness activities across internal teams and external suppliers.

  • Track project milestones, risks, dependencies, and ensure software activities comply with medical device quality system requirements and software lifecycle standards.

Job description

  • Location Marlborough, MA,Marlborough, MA, 01752,United States
  • Employee Type Contractor or FT Employee
  • Required Degree 4 Year Degree
  • Travel 20%
About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role

The ideal candidate will manage Manufacturing Software and Sourced Finished Medical Device software-related workstreams within a medical device integration program. The role will support internal manufacturing software, supplier-managed software activities, software distribution, validation, release planning, production readiness, and transition-to-sustainment activities. This individual will work directly with internal cross-functional teams and SFMD supplier partners to align deliverables, dependencies, risks, documentation, and execution plans. The contractor will partner with Software Engineering, Manufacturing Engineering, Quality, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, Cybersecurity, IT, and external supplier organizations to ensure software activities are completed in accordance with applicable medical device quality system requirements and software lifecycle standards. The successful candidate must bring strong project management discipline, hands‑on Jira proficiency, Agile/Scrum operating experience, and practical experience delivering software projects in regulated medical device environments.

What You’ll Do
  • Lead planning and execution of the Non‑Product Software workstream across Manufacturing Software and SFMD software activities to support product integration and new product development efforts.
  • Develop and maintain integrated project plans, milestone schedules, and project risks, and release plans.
  • Prepare concise status updates, leadership summaries, decision logs, and escalation materials for risk and issue resolution.
  • Coordinate internal and supplier‑facing activities across software, manufacturing, quality, regulatory, operations, cybersecurity, IT, and supply chain stakeholders.
  • Coordinate requirements, design inputs, validation planning, test evidence, release readiness, deployment planning, and production support handoffs.
  • Partner with Manufacturing Engineering, Operations, Quality, Regulatory, and R&D to ensure internal software solutions meet business, production, and compliance needs.
  • Facilitate alignment between supplier deliverables and internal expectations for design controls, change control, validation, cybersecurity, risk management, and regulatory readiness.
  • Identify, track, and escalate dependencies between internal manufacturing systems, supplier‑owned software solutions, product configuration, software distribution, and production release activities.
  • Ensure software project activities are planned and executed in alignment with regulated medical device software lifecycle expectations.
  • Support software planning, requirements management, verification, validation, traceability, risk management, change management, and release processes.
  • Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and audit‑readiness discussions.
  • Track objective evidence and documentation deliverables required for software release, manufacturing implementation, medical device manufacturing integration, and sustainment transition.
  • Participate in agile planning activities, including backlog refinement, sprint planning, daily/weekly team synchronization, sprint reviews, retrospectives, and release planning.
  • Maintain Jira metrics and dashboard for program‑level reporting.
  • Partner with other project managers, leads, and functional stakeholders to clarify priorities and remove blockers.
  • Drive continuous improvement in Agile operating cadence, team accountability, and delivery predictability
What you will bring
  • Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
  • 5 or more years of project or program management experience in the regulated medical device industry.
  • Demonstrated experience managing software development, manufacturing software, non‑product software, or supplier‑managed software projects in compliance‑driven environments.
  • Experience working with internal cross‑functional teams and external suppliers, including SFMD suppliers, contract manufacturers, or supplier software development organizations.
  • Strong working knowledge of medical device software lifecycle processes, design controls, validation, release management, risk management, and change control.
  • Required proficiency with Jira, Confluence, Agile/Scrum planning practices, backlog management, sprint execution, dashboards, and metrics reporting.
  • Strong facilitation, dependency management, risk management, communication, and stakeholder management skills.
  • Ability to operate independently, drive clarity in ambiguous environments, and escalate risks with clear options and recommendations.
  • Certified Scrum Master or equivalent Scrum Master training or experience.
  • Experience supporting acquisitions, product integrations, supplier transitions, or quality system harmonization activities.
  • Experience with manufacturing systems, software distribution, configuration management.
  • Experience with Jira Advanced Roadmaps, portfolio reporting, Agile metrics, and executive‑level dashboarding.
  • Familiarity with cybersecurity requirements for connected medical devices, manufacturing software, or supplier‑managed software environments.
ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.

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