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.
The Supplier Quality Engineer is responsible for supporting supplier quality processes within Novidan’s R&D process, manufacturing facility and supply chain. She or he will be responsible for product quality from suppliers through to the field. The engineer will be responsible for improving Novidan systems in the areas of supplier quality, responding quickly to determine root cause and communicating clearly on any issues therein.
- Responsible for product quality from suppliers to Novidan and in the field.
- Own and enhance supplier qualification process
- Implement supplier quality metrics and scorecard
- Support and improve supplier change notification process
- Troubleshoot supplier related product failures in production and the field
- Determine root cause analysis on supplier failures quickly
- Clearly communicate issues to supplier and Novidan employees
- Drive product improvements with suppliers
- Manage supplier relationships and act as an internal liaison with the supply chain
- Support R&D and continuation engineering projects as the supplier quality representative
- Continually improve Novidan’s and supplier’s processes and production material flow
- Actively participate in the Material Review Board
- Interface with key suppliers on Quality subjects and issues
- Initiate supplier investigations and manage Supplier Corrective Action Requests
- Conduct quality audits internally and externally at suppliers domestically and overseas
- Write excellent test reports, inspection procedures, and process documents
- Capture, manage, and report on production and field data, using statistical analysis tools
- Support and assist other areas of Quality, as needed
- Minimum B.S. in a related Engineering field
- Must have 3+ years of experience in a regulated product field
- Experience with medical devices and ISO 13485:2016, a significant plus
- Six Sigma Green Belt or Black Belt a plus
- Must have excellent writing skills
- Must be able to clearly present data to a group of technical staff.
- Advanced user of Excel and Minitab
- Intermediate to advanced knowledge of statistical analysis methods and tools
- Self-starter, resourceful and able to achieve results with minimal supervision
Normal office and light manufacturing conditions. Mobile work flexibility available.
Less than 10%. Some US or international travel may be required to visit suppliers.
Novidan is growing! We need to add to our critical manufacturing team to continue to meet demand for our products. Join our team today!
The Production Technician is responsible for assembling, testing, and troubleshooting hearing aids and related electronic products. The Production Technician must follow work instructions consistently, troubleshoot complex electronic devices, and perform work independently, with minimal supervision.
- Follow all relevant work instructions to assemble, test, and troubleshoot products.
- Assist in the building of prototype products.
- Build high quality devices that pass all specifications
- Conduct incoming inspection on purchased components and assemblies using the measurement microscope and other tools available.
- Follow shipping and receiving work instructions for incoming and outgoing product.
- Assist in verification and validation assembly and test for new products
- Provide input to continuous improvement ideas and work with engineering to support and implement continuous improvement projects
- Maintain a safe, clean, and efficient work area
Associate in Applied Science (AAS) of Electronics Technology degree or equivalent preferred. 5+ years relevant experience without the degree, required.
Production Technician I: Previous hearing aid assembly and test experience preferred.
Production Technician II: 5+ years of hearing aid assembly required
Job Knowledge and Skills
- Advanced proficiency in electronics assembly using a microscope and solder iron required.
- Advanced proficiency in troubleshooting complex systems required
- Intermediate proficiency in Microsoft Office required.
- Intermediate understanding of acoustics desired.
Electronic production line in normal office conditions. Occasionally lifting up to 50 lbs. required.
Less than 5%. Some US or international travel may be required.
- Comprehensive Medical Plan
- Flexible Spending Account
- Health Savings Account
- Generous Paid Time Off
- 401k Program
- Casual Dress Code
Apply Now! Please email your resume to us at email@example.com.
Novidan is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.