Senior Manager, Software Engineering (R&D)

Senior Manager, Software Engineering (R&D)

Our client is seeking a Senior Manager, Software Engineering (R&D) to lead software and firmware development across its medical device platform, including Software as a Medical Device (SaMD) initiatives where applicable. This role is responsible for guiding software development from early requirements and system architecture through implementation, verification, release, and sustaining support.

This is a hands-on engineering leadership position requiring both technical depth and strong execution skills. The successful candidate will contribute directly to architecture discussions, code and firmware reviews, defect resolution, and technical decision-making while leading development priorities, timelines, and team execution.

The role also oversees software roadmap planning, balancing technical strategy, product priorities, resource allocation, and cross-functional dependencies to support timely, high-quality product delivery. The ideal candidate will collaborate closely with Clinical, Systems, Hardware, Quality/Regulatory, Manufacturing, and Service teams to translate user and business needs into practical software solutions.

Responsibilities:

Software & Firmware Leadership

• Lead software and firmware development activities across new product development and sustaining programs.
• Define technical direction for software architecture, interfaces, device behavior, alarms, controls, sensors, and software-hardware integration.
• Convert user needs, clinical workflows, system requirements, and risk controls into actionable software requirements and development plans.
• Provide hands-on technical leadership through architecture reviews, code reviews, debugging support, integration planning, and defect triage.
• Drive execution priorities, release planning, technical tradeoff decisions, and issue escalation as needed.

New Product Development (Gen 4)

• Lead Gen 4 software architecture, firmware strategy, requirements development, verification planning, and DHF deliverables through design freeze and submission readiness.
• Establish development plans, milestones, review cadence, backlog priorities, and execution tracking.
• Support software-related activities tied to risk management, usability, cybersecurity, verification, and regulatory documentation.
• Partner with hardware, systems, manufacturing, and clinical teams to support product reliability, usability, manufacturability, and serviceability.
• Support prototype builds, design reviews, and pre-submission activities.

Sustaining Engineering (Gen 3)

• Lead sustaining engineering activities for released products, including complaint investigations, root-cause analysis, defect management, CAPA support, and change assessments.
• Prioritize sustaining efforts based on customer impact, product reliability, regulatory obligations, and business needs.
• Ensure updates and software changes are appropriately validated, documented, approved, and transferred to downstream teams.

Quality & Regulatory Support

• Ensure software development activities align with company quality system requirements and FDA expectations related to device software, cybersecurity, verification and validation, and design controls.
• Maintain traceability across user needs, requirements, implementation, risk controls, verification activities, and release documentation.
• Review or approve software lifecycle documentation including architecture documents, firmware specifications, test protocols, reports, release records, and DHF content.
• Support regulatory submissions, audits, inspection readiness, nonconformance activities, and CAPA investigations in partnership with Quality and Regulatory teams.

Team & Cross-Functional Leadership

• Lead and mentor a software engineering team with clear priorities, accountability, and consistent engineering practices.
• Coach engineers on software quality, technical problem solving, and development best practices.
• Foster strong collaboration across R&D, Clinical, Quality/Regulatory, Manufacturing, and Service organizations.
• Communicate project progress, risks, timelines, and resource needs to leadership and stakeholders.

Qualifications:

Required

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
• 8+ years of experience developing software for regulated medical devices, including embedded software, firmware, and/or SaMD.
• 3+ years of engineering leadership or people management experience.
• Experience leading regulated software development activities across requirements, architecture, implementation, verification, release, and sustaining support.
• Strong understanding of FDA software guidance, design controls, complaint handling, CAPA processes, and software documentation expectations.
• Experience translating customer, clinician, or user needs into executable engineering requirements and technical plans.
• Strong troubleshooting, analytical, and decision-making skills in fast-paced development environments.
• Excellent communication and cross-functional collaboration skills.

Preferred

• Experience working within IEC 62304, ISO 14971, IEC 62366, ISO 13485, or QMSR-regulated environments.
• Experience supporting FDA submissions or software-related regulatory filings.
• Familiarity with software cybersecurity practices and post-market product support processes.