The Sr. Systems Engineer is responsible for leading system level product design and development activities for direct-to-consumer hearing aids and sound amplification products. S/He must have the technical expertise in hardware and software domains and the planning and execution skills to realize complex designs with appropriate engineering rigor. S/He is critical member of an interdisciplinary cross-functional team leading system-level design, test planning, verification, validation and technical risks and issues resolution. S/He should relish the challenges of getting technology to work and demonstrate unwavering tenacity, creativity, and problem-solving skills to create and deliver products that improve people’s lives and provide the best user experience imaginable.
- Own and create system level product requirements/design inputs
- Own and lead dFMEAs and system level design risk mitigation and technical tradeoffs
- Own and drive system level troubleshooting and ensure timely and effective solutions
- Lead system level design reviews and documentation
- Own, manage and support V&V test methods, test execution and reporting
- Oversee and support technical design and process discipline and rigor
- Drive and support continuous improvement of system verification capabilities, tests and tools and related documentation
Minimum education, certification and experience requirements:
- MSME/MSEE or related degree with 4 years of experience or BSME/BSEE or related degree with 6 years of experience designing and manufacturing Class II medical devices required.
- Experience managing requirements, technical tradeoffs, V&V, technical issues, and technical risk for class II medical devices required
- Experience executing projects within an established Quality Management System required
- Experience designing and manufacturing Class II wireless hearing aids and accessories or related body-worn, low-voltage products or rechargeable battery-powered wireless consumer electronics highly desired.
Job Knowledge and Skills
- Intermediate to advanced knowledge of Systems Engineering practices and tools, including hardware and software architecture, requirements, tradeoff analysis and V&V
- Intermediate to advanced knowledge of Waterfall and Agile product development processes and tools highly desired
- Intermediate knowledge of requirements management best practices
- Intermediate to advanced knowledge of mechanical, electrical and environmental test equipment highly desired.
- Intermediate to advanced knowledge of IEC 60601-x Medical Device Safety standards highly desired
- Intermediate to advanced knowledge of MS Office tools.
- Resourceful self-starter, able to work with minimal supervision.
- Excellent organizational and problem-solving skills.
- Excellent verbal and written communication skills.
Normal office and lab conditions with mobile work flexibility.
Some US or international travel may be required.