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Manager Medical Device Software Engineer Jobs in Massachusetts

Inherent Technologies

Project Engineer

Danvers, MA · On-site

Minimum of 1 year experience in the medical device industry as well as Medical Device Software ... Project Management Professional (PMP) Certification * Experience working with Agile development ...

Jj

Staff Software Engineer - Navigation

Boston, MA · On-site

Experience in developing regulated medical device software (SaMD) under standards like IEC 62304 ... Management, Software Engineering Practices, Software Quality Assurance (SQA), Systems Development ...

EdgeBeam Wireless, LLC

Senior Software Engineer

Boston, MA · On-site

$130 - $180/hr

Develop scalable device fleet configuration and lifecycle management systems Integrate agentic AI ... Engage with network and device software engineers to build APIs and SDKs above ATSC 3.0 and hybrid ...

New

Philips

Software Design Quality Engineer

Bedford, MA

$102K - $163K/yr

Job TitleSoftware Design Quality Engineer The Software Design Quality Engineer is responsible for ... management. * Track and risk assess software Anomalies for pre- and post-market medical device ...

Philips

Software Design Quality Engineer

Bedford, MA · On-site

$102K - $163K/yr

Job Title Software Design Quality Engineer The Software Design Quality Engineer is responsible for ... management. * Track and risk assess software Anomalies for pre- and post-market medical device ...

SharkNinja

Compliance Engineer

Needham, MA

... Management for Medical Devices ISO 13485 - Quality Management Systems IEC 62366-1 - Usability Engineering IEC 62304 - Medical Device Software Lifecycle (where applicable) ISO 10993 series ...

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Manager Medical Device Software Engineer information

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.
What are the most commonly searched types of Medical Device Software Engineer jobs in Massachusetts? The most popular types of Medical Device Software Engineer jobs in Massachusetts are:
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What cities in Massachusetts are hiring for Manager Medical Device Software Engineer jobs? Cities in Massachusetts with the most Manager Medical Device Software Engineer job openings:
Manager Medical Device Software Engineer jobs near you

Project Engineer

Inherent Technologies

Danvers, MA • On-site

Other

Re-posted 15 days ago

Job description

Position: Project Engineer

Location: Danvers, MA ***Day 1 Onsite***

Duration: 1 Years


Key Responsibilities

  • Collaborates with the agile team to translate the business vision into language that can be consumed by development resources.
  • Develop and manage the software design history file
  • Support Project Documentation and Materials needs via SAP
  • Maintain JAMA tool and produce required documentation for the design history file
  • Track project performance, specifically to analyze the successful completion of short- and long-term goals
  • Meet budgetary objectives and make adjustments to project constraints based on financial analysis
  • Develop comprehensive project plans to be shared with management as well as other staff members
  • Collaborates with team in identifying workflow and process gaps and issues
  • Assists in backlog grooming and maintenance
  • Organize and conduct reviews with stakeholders and development teams
  • Coordinate cross-functional reporting across teams - ensuring inter-dependencies are documented, understood, and communicated.
  • Use and continually develop leadership skills


Job Qualifications

  • Bachelor's Degree in Engineering/Technology
  • Self-reliant; takes initiative; results-oriented; collaborative
  • Capable of managing time and project assignments with minimal oversight
  • Ability to meet tight deadlines in an environment of competing priorities
  • Proven commitment to proactive planning, thoroughness, and excellent execution
  • Well organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project success
  • Excellent team-work and coordination, professionalism and discipline
  • Limited travel might be required.
  • Minimum of 1 year experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)
  • Demonstrates knowledge of quality policies, principles and best practices and FDA/ISO requirements

A strong candidate will also have

  • Experience supporting FDA regulated products
  • Project Management Professional (PMP) Certification
  • Experience working with Agile development with a Continuous Discovery/Delivery mindset
  • Experience delivering SaaS
  • Experience working directly with software engineers