Job Description: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
