Director, Project Management & Design Assurance - United States
|Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Always focused on innovations that improve quality of life, AB has consistently made the industry’s leading advancements in hearing technology. In fact, with six sound coding programs, we offer more ways to hear than any other cochlear implant company. |
Our company is part of the Sonova Group, the leading provider of hearing healthcare solutions and parent company of Phonak, the leading hearing instrument brand.
As an AB employee, you will contribute to advancing biomedical technology worldwide and work on challenging projects with smart, driven, friendly people.
AB provides thriving work environments around the globe; each fosters creativity, teamwork, global competitiveness, and professional growth.
Experience the professional and personal fulfillment that comes with making a difference in people’s lives. Apply to Advanced Bionics today.
|Advanced Bionics / USA / Valencia (CA)|
|Director, Project Management & Design Assurance|
| Tasks & Responsibilities |
Purpose of the job: As a senior member of the R&D Management team, the Director is responsible for execution and delivery of the product roadmap. The Director, Project Management & Design Assurance oversees all product development projects and manages the team of Project Leaders that lead the product development teams. This position has responsibility for the timeline, budgeting, and quality of the product development projects. Strategic management of the product development portfolio includes key engineering decisions, resource allocation, risk management, and project schedule management. Close collaboration with the line managers (Directors, Senior Managers) of the engineering functions is essential.
The role also includes responsibility for the Design Assurance function which is responsible for Requirements Engineering, Risk Management, and standards compliance.
Main Tasks & Responsibilities:
1.Line Management: Responsible for staffing the Project Leader and Design Assurance teams with high caliber personnel and maintaining the skill levels of the team. Provide coaching, mentoring and consistent personnel development.2. Product Development: Provide input and insights into ongoing product development projects to help steer the projects. Resolve key engineering and product development decisions.
3. Product Development: Work with key engineering stakeholders to mitigate risk, manage schedule, and guide development of Class III Active Implantable Medical Devices. Budgeting: Responsible for overseeing the production development budgets
4. Product Development: Responsible for executing the Standard Development Process and related Design Controls. Represent the development process and projects to external regulatory auditors.
5. Product Development: Provide guidance on resource allocation and overall R&D group development, skillsets, etc. in the context of the product development roadmap.
6. Design Assurance: Oversee all product development risk management activities. Lead strategy to reduce product and project risk.
7. Design Assurance: Oversee DA related project tasks: Hazards analysis, risk analysis, FMEA, Fault Tree Analysis, and related risk management processes.
8.) Management: Report project progress and risks to executive management.
| Basic Education |
Need to have: Engineering DegreeNice to have: MSEE or PhD
Need to have:
1.) 10+ years experience leading product development teams in highly complex environments (complicated development projects & matrix environments)
2.) 15+ years project management experience3.) Experience with risk management processes and design controls.
4.) Engineering and product development experience with micro-electronics, mechanical engineering, embedded code and software engineering.
Nice to have:
1.Experience in Class 3 medical devices (Active Implantable products)2 Experience with regulatory audits and Class III product approval processes
|Advanced Bionics is committed to creating a diverse environment and is proud to be an affirmative action/ equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.|
|Advanced Bionics LLC |
28515 Westinghouse Place
Valencia, CA 91355
+1 661 362 4747