Manager Software Engineer

 

The Manager, Software Engineering (R&D) leads software and firmware development across the GENOSYL DS platform.  This leader owns end-to-end development of device software functions, including software as medical device where applicable, from user needs and intended use through architecture, software requirements, implementation, verification, release, design transfer, and post-market sustaining.

 

This is a working manager role. The successful candidate is expected to be technically credible in architecture reviews, firmware and code reviews, defect triage, and day to day product decisions, and to guide the team, review the work deeply, solve problems directly, and drive timelines and quality simultaneously. In addition, this role owns and drives the software and firmware roadmap, translating strategy into executable plans with clear milestones, priorities, and resource alignment; actively managing dependencies, risks, and tradeoffs; and ensuring on time, high quality delivery of committed roadmap objectives.

 

The ideal candidate can translate user and clinical needs into clear software requirements and product direction, and collaborate effectively with clinical teams, Quality/Regulatory, systems engineering, hardware R&D, manufacturing, and service to deliver best-in-class products to market.

 

Success in this role will be measured by:

• Gen 4 software architecture, requirements, review discipline, and cross-functional integration are established and advancing on plan. 
• Gen 3 sustaining needs are addressed, including investigations and life-cycle improvements, prioritized, and implemented with high-quality documentation, technical rigor, and execution discipline.
• Software requirements, traceability, code-review discipline, and documentation quality become materially stronger across the team.

 

Near-Term Priorities

• Lead Gen 4 software architecture, firmware strategy, requirements, interfaces, verification strategy, and design-history deliverables through design freeze and submission readiness.
• Own Gen 3 sustaining software work, including software-related complaint investigations, reliability improvements, disciplined change control, and support for FiO2 and other sustaining updates.
• Translate user and clinical needs into clear software requirements and align software direction with hardware, Quality/Regulatory, manufacturing, service, and broader R&D execution.

 

Technical Leadership & Product Delivery

• Lead day-to-day execution for software and firmware development, including planning, prioritization, technical decision-making, and direct problem solving.

• Own software architecture and interface definition for device behavior, user interface, alarms, sensors, controls, and other software-hardware interactions relevant to the product.
• Translate user needs, clinical workflows, intended use, system requirements, and risk controls into clear, testable software requirements and design outputs.
• Participate directly in architecture reviews, code reviews, debugging, design reviews, integration planning, and defect triage rather than managing only through status updates.
• Set software product direction, define release content, make sound technical tradeoffs, and escalate issues early enough to protect timelines and quality.

 

​​​​​​​Gen 4 Development

• Build and maintain the Gen 4 software development plan, milestone structure, backlog, review cadence, and technical execution model.
• Lead software contributions to system architecture, firmware, risk management, usability, cybersecurity, verification, and submission-ready documentation.
• Support prototype builds, design reviews, pre-submission planning, design freeze criteria, and cross-functional problem solving as the Gen 4 platform advances.
• Partner with hardware, systems, clinical, and manufacturing-development teams to ensure the product is usable, reliable, manufacturable, and serviceable.

 

Gen 3 Sustaining

• Own software-related complaint investigations, defect triage, root-cause analysis, CAPA inputs, and change assessments for released products.
• Prioritize sustaining work based on customer impact, regulatory commitments, and business priorities.
• Ensure software changes to released products are validated, documented, approved, and transferred cleanly to manufacturing and service teams.

Quality, Regulatory, and Design Controls

• Ensure software lifecycle activities and records comply with the company QMS and FDA expectations for device software functions, cybersecurity, verification and validation, and design controls.
• Drive traceability from user needs and design inputs through software requirements, implementation, risk controls, verification evidence, and release documentation.
• Lead or review software architecture documents, firmware specifications, software requirements, test protocols and reports, release notes, and design-history-file content.
• Partner with Quality and Regulatory on submissions, audits, inspection readiness, nonconformances, CAPA actions, and complaint investigations.

​​​​​​​Collaboration & People Leadership

• Build a strong, accountable software engineering team with clear priorities, practical development processes, and consistent review standards.
• Coach engineers in code quality and disciplined problem solving.
• Have productive, creative discussions with clinical teams, Quality/Regulatory, systems engineering, and hardware R&D to deliver best-in-class products to market.
• Communicate status, technical risks, decisions, handoffs, and resource needs clearly to leadership and cross-functional partners.

 

 

Required Qualifications

• Bachelor's or Master's degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or a related field.
• Eight or more years of experience in software development for medical devices, including embedded software, firmware, and/or software as a medical device.
• At least three years of technical leadership and/or people-management experience leading engineers through real product delivery.
• Demonstrated experience leading end-to-end development of regulated medical-device software, including requirements, architecture, risk management, implementation, code reviews, integration, verification, release, and sustaining.
• Strong working knowledge of FDA software guidance, medical-device design controls, complaint and CAPA processes, and submission-ready software documentation.
• Experience translating user needs, clinician feedback, and system requirements into software requirements and executable technical plans.
• Strong debugging and problem-solving skills, with the ability to go deep technically and make sound decisions under timeline pressure.
• Excellent cross-functional collaboration skills with clinical, hardware, Quality/Regulatory, manufacturing, and service teams.

Preferred Qualifications

• Experience working within IEC 62304, ISO 14971, IEC 62366, software cybersecurity practices, and ISO 13485 / QMSR-driven quality environments.

• Experience supporting FDA submissions or major software-related regulatory filings for new products or significant design changes.

• Experience with design transfer and field-performance feedback loops for device software and firmware.  

 

Competencies

• Technical Depth--Gets into architecture, firmware, requirements, code review, and integration details when the team needs help or decisions are stuck.

• Problem Solving--Debugs effectively, makes sound tradeoffs under schedule pressure, and closes issues with rigor.

• Quality & Design Controls--Maintains traceability, documentation rigor, risk control, verification discipline, and regulatory readiness in a medical-device environment.

• Cross-functional Collaboration--Translates user and clinical needs into software requirements and works effectively across clinical, hardware, Quality/Regulatory, manufacturing, and service teams.

• Accountability & Leadership--Pushes timelines and quality simultaneously, creates ownership and clarity, and builds an accountable engineering culture.