At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.
The Digital Firmware Scrum Master will drive predictable firmware delivery within a structured product development environment. In this role, you will facilitate team‐level scrum execution while coordinating project activities using traditional (waterfall) project management practices. You will ensure alignment between firmware development plans and device‐level program schedules, maintain adherence to internal engineering and product development processes, and support the documentation and compliance needs of an FDA 510(k) regulated environment.
You will work cross‐functionally with engineering, quality, regulatory, and program teams to track progress, manage dependencies, resolve issues, and ensure that documentation and change‐control requirements are fully met for each release. This is a hands-on coordination and delivery role for someone who thrives in changing environments, can adapt to shifting priorities, and enjoys balancing process with practical problem-solving.
Accountabilities & Responsibilities
- Facilitate Scrum ceremonies (daily stand‐ups, sprint planning, sprint reviews, retrospectives, and backlog refinement) to maintain cadence, visibility, and consistent Scrum/Scrumban practices.
- Use Azure DevOps (ADO) boards, queries, and dashboards to track team progress, maintain data quality, and surface blockers while ensuring alignment to traditional project plans.
- Identify and remove impediments promptly; manage dependencies across engineering, QA, integration, and program teams.
- Build and maintain integrated project and release plans, ensuring alignment to device‐level program schedules, milestones, and phase gates.
- Coordinate release‐readiness activities (entry/exit criteria, checklists, sign‐offs) and drive on‐time firmware delivery aligned to the device program plan.
- Track delivery commitments against milestones; forecast based on throughput and scope changes; escalate risks and decision needs early with clear options, impacts, and proposed mitigations.
- Provide clear, concise status on schedule, scope, risks, and dependencies to engineering leadership and program stakeholders; maintain a RAID/decision log and drive items to closure.
- Ensure adherence to internal development processes (PDP/SOPs, design controls) and consistent use of required templates and checklists for regulated medical device software/firmware.
- Maintain bidirectional traceability across requirements, risks, and verification/validation; verify mandated reviews and approvals are performed and recorded.
- Identify all documentation updates required for each firmware release (e.g., requirements/specs, design descriptions, risk files, V&V plans/protocols/results, traceability matrices, release notes).
- Plan, coordinate, and track document revisions; route formal reviews, collect and follow up on review comments to resolution; maintain correct version control.
- Manage document change‐control activities (e.g., initiating and progressing document change requests); ensure proper approval routing; publish final artifacts in the document change‐control system prior to release; maintain an audit‐ready release package aligned to FDA 510(k) expectations.
Qualifications
Education & Experience
Required:
- 3+ years as a Scrum Master, Project Coordinator, Release Coordinator or similar role in software or firmware development.
- Demonstrated ability to manage multiple concurrent projects at different SDLC/phase‐gate stages (from concept through maintenance), balancing Scrum cadence with device‐level milestones and dependencies.
- Experience operating within highly structured internal processes (e.g., PDP) and maintaining documentation/checklists to ensure compliance with regulatory guidelines.
- Willingness to become an expert in FDA 510(k) regulations and documentation requirements for a regulated medical device.
- Proficiency in Azure DevOps (ADO) or similar tools.
- Ability to communicate clearly with both technical and non-technical stakeholders.
Preferred:
- Experience with embedded software or firmware development in a regulated environment (e.g., HIPAA, FDA).
- Familiarity with FDA expectations for medical‐device cybersecurity.
- Experience implementing IEC 62304 software life‐cycle processes and integrating ISO 14971 risk management in a medical‐device firmware context.
- Familiarity with formal quality assurance activities within software, firmware, or hardware engineering.
- Knowledge of modern software development practices (CI/CD, test automation, cybersecurity, observability).
- Some formal Agile or Project Management training or certification (e.g., PMP, CSM, SAFe) is a plus.
Knowledge & Skills
- Adaptability & Flexibility — thrives in changing environments; adjusts contributions to evolving priorities.
- Organization & Prioritization — manages multiple initiatives with clarity and precision.
- Communication — conveys complex status, risks, and trade-offs to executives and teams.
- Problem Solving & Ownership — anticipates issues, proposes solutions, and drives results.
Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.
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Top Skills
What We Do
Tactile Medical is one of the fastest growing companies in medical devices. As a leader in treatment options for lymphedema and venous ulcer therapies, Tactile Medical develops advanced home therapy devices to improve health and quality of life for patients with chronic swelling . Headquartered in Minneapolis, Minnesota, we advocate for patient access and serve tens of thousands of patients through a direct national network of product specialists and trainers, reimbursement experts, patient advocates, and clinical staff.
