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Manager Medical Device Software Engineer Jobs in Wisconsin

... medical devices, including operating system configuration, board support packages, device drivers ... management, deterministic system performance, and hardware-software integration. * Strong ...

Embedded Software Engineer

Wauwatosa, WI

$127K - $168K/yr

... Management Tool, Rally, embedded Linux tool chain Demonstrated experience with development of medical device software Qualifications Requirements: Bachelor's Degree in Electrical Engineering ...

... medical device compliance requirements (IEC32604) * Senior Management/Stakeholders - Provides ... Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related ...

... medical device compliance requirements (IEC32604) * Senior Management/Stakeholders - Provides ... Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related ...

Job Title: Medical Device Assembler Location: Madison, WI (Onsite) Pay Rate: $23-24/hr on W2 ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

This role oversees CAPA, Change Management, investigations, deviations, Quality Management Reviews ... Experience with statistical analysis software (e.g., Minitab preferred) Organizational Relationship ...

Hi - My direct client is looking for a Software Engineer. If you're interested, please email me ... Experience in medical device or FDA‑regulated industries. * Knowledge of data integrity rules ...

... medical device. Our work has a daily impact on patients worldwide, and we hold a high bar for quality and rigor. REPORTING TO/DEPARTMENT: Reports to the Manager, Software Engineering in the Software ...

... medical device. Our work has a daily impact on patients worldwide, and we hold a high bar for quality and rigor. REPORTING TO/DEPARTMENT: Reports to the Manager, Software Engineering in the Software ...

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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 Wisconsin? The most popular types of Medical Device Software Engineer jobs in Wisconsin are:
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What cities in Wisconsin are hiring for Manager Medical Device Software Engineer jobs? Cities in Wisconsin with the most Manager Medical Device Software Engineer job openings:

Leo Cancer Care: Senior Software Engineer - Interoperability

Leo Cancer Care

Middleton, WI • Hybrid

$125K - $165K/yr

Full-time

Posted 14 days ago


Job description

Position Title: Senior Software Engineer - Interoperability

Reports to: Senior Manager Global Software Engineering

FT/PT : Full-time

Location: US Office, Hybrid- Office 3 days a week

Position Summary: Join our dynamic engineering team to help develop our revolutionary radiotherapy products for upright therapy. This role sits at the intersection of medical device software engineering and clinical systems integration, with a primary focus on DICOM-RT interoperability between our treatment system and the broader clinical ecosystem - including Oncology Information Systems (OIS), PACS servers, and other networked medical devices.

The ideal candidate brings deep hands-on experience with DICOM-RT standards, network-level system integration, and medical device software development under IEC 62304. You will play a key technical leadership role in defining and implementing the interoperability architecture that connects our treatment delivery system to the clinical workflow, working closely with partners, clinical customers, and internal cross-functional teams.

The position requires flexibility in daily tasks with attention to detail and a self-motivated work ethic. The successful candidate will havedemonstratedexperience working in cross-functional and cross-disciplinary teams and providing technical leadership in the development of novel products.

Key responsibilities:

  • Lead the design, specification, and implementation of DICOM-RT interoperability features, including RT Plan, RT Dose, RT Structure Set, RT Image, and RT Ion Plan objects.
  • Architect and develop network API interfaces enabling communication between the treatment delivery system, OIS (e.g.ARIA,Mosaiq), and PACS servers.
  • Define andmaintainthe system's DICOM Conformance Statement and related integration documentation.
  • Drive end-to-end integration testing with clinical systems, including HL7/FHIR messaging where applicable.
  • Perform as a technical lead on significant software development projects spanning interoperability and clinical connectivity.
  • Write specifications, requirements, design documents, and test protocols for software projectsin accordance withIEC 62304 and thecompanydesign control process.
  • Develop safety-critical software for imaging and treatment delivery systems.
  • Work with external partners and clinical customers to develop,validate, and support system interfaces and integrations.
  • Contribute to the design and development of service and validation tools for DICOM interoperability.
  • Provide engineering support to partners, customers, and field service teams.
  • Support regulatory submissions (e.g.510(k)) as they relate to interoperability and software.
  • Contribute to system architecture and software development process improvements.
  • Mentor less experienced engineers in interoperability standards and medical device software practices.
  • Manage contractors relating to softwarecomponentdevelopment where applicable.

Relevant Knowledge and Skill requirements:

DICOM-RT and Clinical Interoperability

  • Deep working knowledge of DICOM-RT standards: RT Plan, RT Dose, RT Structure Set, RT Image, RT Ion Plan, and related SOP classes.
  • Practical experience integrating radiotherapy treatment systems with Oncology Information Systems (OIS) such as Varian ARIA or ElektaMosaiq, and PACS servers.
  • Proficiencywith DICOM networking protocols: C-STORE, C-FIND, C-MOVE, C-GET, DICOM TLS, Storage Commitment, and Worklist services.
  • Experience developing ormaintaininga DICOM Conformance Statement.
  • Familiarity with HL7 v2 and/or FHIR messaging as used in oncology workflows isadvantageous.
  • Understanding of IHE Radiation Oncology profiles (e.g.RO-PIR, IHE-RO) is a plus.

Medical Device Software Engineering

  • Proven experience developing medical device software in compliance with IEC 62304, including software lifecycle planning, classification, architecture, unit testing, and maintenance.
  • Familiarity with associated standards and guidance: ISO 14971 (risk management), IEC 62443 (cybersecurity), and applicable FDA/CE regulatory requirements for software.
  • Experience supporting regulatory submissions (510(k), CE Technical File) for software-intensive medical devices.
  • Experience with design and specification of software systems using UML.

Networking and Software Engineering

  • Solid understanding of TCP/IP networking: routing, firewalls, VLANs, TLS/SSL, and network security as it applies to connected medical devices.
  • Experience with REST and/orgRPCAPI design and integration in a clinical or embedded systems context.
  • Strong programming skills in Python and at least one of C++, C#, or Java.
  • Experience with Linux, shell scripting, and systems-level debugging.
  • Proficiencywith version control (Git), CI/CD pipelines, and software testing frameworks.

Experience

  • Minimum 5 years of domain-specific experience in medical device software engineering within radiotherapy, radiation oncology, or a closely related imaging/treatment modality.
  • 10+ years of total software engineering experience, withdemonstratedseniority in at least one prior role, is strongly preferred.
  • Experience working in cross-functional teams including clinical physics, systems engineering, quality, and regulatory affairs.
  • Ability to mentor and provide technical leadership to less experienced engineers.

About Leo Cancer Care

Leo Cancer Care is helping make changes in Radiation Therapy by shifting to upright patient positioning, imaging and treatment. We do what we do to find a better way, a better way to treat cancer and create a paradigm shift in radiation therapy to benefit all. We will do this by improving the accessibility and medicine in cancer care globally, making cancer treatment a more human experience for all.

Working in radiotherapy not only will you be driving change for the greater good, but you'll be working on products that span a large field of different disciplines.

Ways of Working

Leo Cancer Care is dedicated to fostering a diverse and inclusive workplace environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all.


Leo Cancer Care is an equal opportunity employer.