Required Knowledge and Experience
- Bachelor's or Master's degree required with Minimum of 15+ years of relevant experience
- Manage a cross functional engineering technical team size of 15+.
- Provide a blend of people management and technical savviness. Should have worked in matrix reporting structures with accountability on successful delivery of solutions.
- Demonstrated expertise in software Verification & validation, Embedded systems, including strategy, design, and implementation.
- Proficiency in an object-oriented language Advanced C++/C#.
- Experience in gtest/gmock
- Experience in CMake ,Git
- Strong proficiency in Python programming for test automation, scripting, and tool development.
- Experience with one or more: TDD, Unit Test, continuous integration and delivery.
- Experience with distributed real-time software.
- Experience performing risk management analysis of software (e.g. SW FMEA).
- Familiarity with real-time operating systems such as QNX.
- Deep understanding in product development processes & regulations (ex: ISO 13485, ISO 14971) Design controls for medical device development to coach and guide the technical leads is expected.
- Identify the needs and prepare capabilities in the cross functional areas, SW development and verification and validation areas to foster full turnkey solution to the business.
- Provide a deep understanding of the embedded and application SW development processes (Agile, waterfall methodology) and help establish SW metrics & recommend the processes for the team.
- Experience with validation of test methods, hard and software, test fixtures.
- Knowledge of principles and applications of biomechanics, physics, mechatronics, and electrical, mechanical and software development.
- Solid understanding of Design Controls, Medical Device Design Verification, and GDP (Good Documentation Practices)
- Knowledge of how to manage teams in a large organization, especially at multiple locations and remotely.
- Great communication skills: Strong ability to coordinate people and teams around unstructured challenges and moving project priorities.
- Fluency in English
- Medical robotics, medical capital equipment, or highly regulated industry experience
- Software architecture and model-based development best practices
- Reports to Associate Engineering Director / Engineering Director
- Accountable to Project Manager(s) for project-related responsibilities
- Frequent interaction with team members from other disciplines, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors, and other users.
- Possible interaction with clinicians, third-party vendors, manufacturers, and subcontractors.
- Oversees activities of the company's development and design requirements for software systems, applications and software quality assurance for enhancements and new products, including cloud-based or internet-related tools, to meet the current and future Software needs.
- Manages activities to assure programs are appropriately resourced and ensure continuous improvement in technical capability, process, and compliance.
- Manages scope, cost, and schedule within a cross-functional development team.