Job Description:TransMedics is transforming organ transplant therapy with the Organ Care System (OCS)-the first portable warm-perfusion platform that keeps donor organs functioning outside the body. Its technology built to give more patients a chance at a transplant, and more transplant teams the confidence to say yes to an organ they'd otherwise have to turn away.
The Sr. Director of Software Engineering owns the embedded and digital software architecture, requirements, and validation strategy behind that technology-software that must work correctly every time, with an organ depending on it. This is a senior leadership role with a seat on the R&D leadership staff, driving the long-range software strategy across next-generation Organ Care Systems.
This is a build role, not a maintain role. As the OCS platform grows more capable and TransMedics scales, the software organization needs a leader who can set the multi-year architecture and capability strategy-while staying close enough to drive requirements definition and design translation personally when a program is under pressure. We're looking for someone equally comfortable owning the technical roadmap and driving detailed execution when it counts.
Key Responsibilities- Set department strategy - define the strategy for Software Development within R&D, including the capabilities needed for TransMedics' future.
- Own software architecture - lead the overall embedded and digital architecture, requirements definition, design, and testing for next-generation Organ Care Systems, ensuring compliance with regulatory standards. This includes working cross-functionally to translate system-level performance requirements into software systems and subsystems.
- Lead design partners - provide leadership, oversight, and guidance to internal and external design partners for new products.
- Stay hands-on - bring a hands-on approach to software strategy, driving detailed execution of requirements definition and design translation through verification and validation.
- Lead validation - own the software validation strategy for new product development, facilitating protocol and report generation across internal and external test labs.
- Own goals & planning - set and monitor department goals to achieve corporate and project objectives, and own project planning, budgeting, and scheduling.
- Partner cross-functionally - work closely with Quality Assurance, Supply Chain, Regulatory, and Clinical to keep programs moving.
Strategic Focus Areas- Embedded & Digital Architecture - own the software architecture and capability roadmap across embedded and digital systems.
- Design Excellence & Compliance - ensure software meets FDA and international regulatory standards the first time.
- Hands-On Technical Leadership - stay close enough to the work to personally drive requirements translation and validation when a program needs it.
- Team Building & Development - grow a high-performing software organization built to scale with the company.
- Cross-Functional Partnership - work seamlessly with Quality, Supply Chain, Regulatory, and Clinical to bring products to market.
Management Responsibilities- Direct management of the Software Development department, including performance reviews and professional development planning.
- Oversight of external design partners is a critical part of this role.
Minimum Qualifications- MS in Computer Science or a related field, plus 10+ years of software development experience, including experience leading software development teams.
Preferred Qualifications- Advanced degree (MS/PhD) in Computer Science or a related field.
- Direct knowledge of regulatory requirements and industry standards in the medical device industry.
- Strong leadership skills with experience leading teams through complex research projects from concept to completion.
- Deep knowledge of the state of the art for embedded and digital software development, including architecture development, requirements management, Agile methodologies, test/test automation, and software release management.
- Proven ability to lead a team (internal and external) to deliver high-quality, robust, complex software solutions compliant with US and international requirements.
- Class II or III medical device experience.
- Hands-on experience designing, testing, and formally verifying software systems with remote monitoring capability.
- Clear, confident communicator, written and verbal.
- Comfortable exercising independent judgment and driving results autonomously.
Work Environment- General office environment.
- Ability to lift up to 25 lbs.
- May travel up to 10% domestically.
Employee Benefit:Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
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