The Software Manager is a member of the team that specifies, designs, develops, tests, and supports complex energy-based (Laser/ RF / HIFU) medical aesthetic devices. This role requires strong software technical experience, proficiency in problem solving, and a strong passion for delivering high quality products. The candidate will be able to help guide and grow the team's careers and long-term goals as they take on everything from embedded development to cloud services.
In this role, you will be hands-on and manage a Team of Software Development Engineers and lead the development activities regarding new product development and sustaining products. Working with other R&D functions, this role manages and maintains the software development processes and delivery strategies for software systems. The candidate will interact with various groups across the organization from Quality, NPI, LCE (Life Cycle Engineering), Systems, UX/UI, Service and Regulatory in the specification, design, development, integration, test, and support of integrated laser and software systems.
Essential Job Functions
- Manage day-to-day activities of the Software Development Engineering team by setting priorities according to the department and corporate overall strategic plans.
- Ensure that software development lifecycle processes meet global medical regulatory requirements, internal Quality requirements, and regulatory standards for Class II medical devices (FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 60601)
- Actively participate in the planning, managing, and reporting regarding software development schedules, communicate changes due to risk or scope increases, prepare mitigation plans, and execute plans as prescribed
- Work with software technical leads, system architects and program managers to ensure software engineering tasks are identified and managed appropriately
- Make project execution decisions either solely or in conjunction with project and product teams
- Ensure projects adhere to the Candela software development lifecycle process (SDLC)
- Create, update, and maintain development SOPs and best practices for the software engineering group to continue compliance with applicable regulations and standards
- Actively participate in software technology and software architectural decisions
- Provide software technical leadership inclusive of individual contributions on projects
- Provide guidance regarding software design reviews to software technical leads and software engineers
- Maintain and manage the software development environment and associated software tools
- Manage software engineering resources, development plans and growth, coach and counsel, recognize performance issues and drive improvement
- Recruit software engineering resources
- Provide recommendations on external development partners, hiring of temporary resources, and the procurement of equipment
- Continual improvement of software departmental operations
- Degree in Software / Computer / Electrical Engineering or related Engineering discipline
- Minimum of 5 years of related experience in software engineering of complex medical devices, preferably medical capital equipment, through multiple complete product development life cycles from concept through manufacturing transfer
- Minimum 5 years leading software development teams through multiple complete product development life cycles
- Minimum 5 years of experience in a leadership role with demonstrated ability to hire, coach, mentor, and develop team members
- Experience with FDA Quality System Regulations (820.30 design controls), Risk Management (ISO 14791), Medical Electrical Equipment (IEC 60601), and Medical Device Software (IEC 62304) for Class II medical devices (Certifications a plus)
- In-depth understanding of software engineering within the regulated medical environment, including embedded systems, hardware interface protocols and communication, and the specification of software requirements
- Experience in Software project management (Agile, Scrum, Kanban experience a plus).
- Experience with C|C++|C#, embedded design tools, Windows, Linux, SBC platforms, PIC processors, and methods to automate tests
- Minimum 5 years of experience in C#/.NET for Windows multi-threaded desktop application development with WinForms/WPF/HTML
Additional Bonus Skills
- Minimum 5 years of experience with relational databases such as SQL Server
- Experience with source code and application security
- Experience using web services, or IoT related applications.
- Experience with development tools relating to requirements management, defect tracking, build & release management, and version control under a Windows environment
- Excellent interpersonal, organizational as well as verbal and written communication skills
- Familiarity with high power laser products is a plus
- Experience managing global/offshore team is a plus
Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.