Director of Software EngineeringOur client, a privately held medical device start-up company on-track to have an approved 510(k) within 2023 is looking for a Director of Software Engineering to be responsible for defining and optimizing process, driving innovation, leading teams, establishing and executing on software development goals and establishing a culture of quality. The Director of Software Engineering will lead a direct Software team including: Firmware, UI Development and SW Verification of about 12 -15 employees currently, with a plan to add some additional headcount next year. In addition, the Director of Software Engineering will manage external vendors and contractors for CyberSecurity, Embedded Operating System Design and Development, a Development Testing team and the Mobile App Team.

Although the Director of Software Development will lead the design, development, testing and maintenance of Software (Qt, Linux, Cloud, Mobile) and Embedded Firmware for our medical devices, as well as manage the engineering support and sustaining engineering activities of released products, The Director will need to have more technical expertise within embedded Software and Firmware with excellent Leadership Change management skills. This role is critical in leading our mission of developing solutions that improve lives impacted by kidney disease.Perks and Benefits: Excellent Medtech Start-up Work Culture and Team
Competitive Pay + bonus + equity in the company
Great Benefits and 401k plan
Flexible Work Schedule
Work strategically to build and develop a Successful Team and see your decisions make a difference
Director of Software Engineering Responsibilities: Meet software development objectives on time and with a level of quality performance
Recruit, train, mentor, lead and retain best in class software engineering team that includes both employees, contractors and third party development partners
Own software resource strategy and planning, including strategic working relationships with external partners
Develop and continuously improve efficient and compliant medical product development processes ensuring quality output, complying to ISO 13485 and IEC 62304 standards.
Collaborate with product owners, architects, users and cross-functional groups and to translate corporate needs into high quality implementations
Work with project managers, product owners, and technical leads to influence scope and priorities for product development
Be accountable to the timely execution of project schedules
Inspire and motivate the development teams to deliver innovative and exciting solutions with an appropriate sense of urgency
Ensure a culture of design excellence, maturity, quality, collaboration, planning, and responsiveness in the software development team.
Ensure department budgets, schedules, and performance requirements are met.
Develop a strong relationship and shared vision with senior management. Help establish a common vision of development plans and priorities that align with corporate goals.
Contribute to design reviews and other key meetings to drive technical solutions for product improvement
Provide effective employee performance management utilizing goals, constructive feedback and coaching for improvement
Director of Software Engineering - Medical Device - Experience and Required Skills: Bachelor’s degree in computer engineering or computer science (Masters preferred)
Minimum of 10 years of R&D experience, at least 5 of which should include managing both direct reports and outsourced development partners or vendors and technical product should include complex electro-mechanical systems with fluidics, pumps, software, hardware, firmware or similar within the medical device industry.
Demonstrate specific examples actioning change and influencing culture within an engineering organization
History of growing a technical team and experience with organizational design
A track record of launching software for complex electromechanical medical devices
In-depth knowledge of the product development process and medical device design control requirements is required (21 CFR 820, ISO 13485). Working knowledge of GMP's and ISO standards
In-depth knowledge of the software product development lifecycle (IEC 62304) is required
Excellent communication skills with the ability to convey technical and business information clearly and effectively through informal and formal documents, reports, and presentations to senior management

Job Type: Full-time

Pay: $190,000.00 - $217,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Irvine, CA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Medical Device IEC 62304: 5 years (Required)
• people leadership: 6 years (Required)

Work Location: One location

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