Auris is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.
The R&D Manager, Flexible Instruments, will guide and lead the development of flexible instruments and catheter-related product development efforts across all endoscopic platforms at Auris. This individual will manage technical team that is responsible for designing and testing these products, as well as leading the process development efforts for all internal and external manufacturing of assigned projects. Data-focused, this person will require proven engineering problem-solving skills and structured analytical abilities, and shall apply engineering, scientific, and clinical knowledge to lead his or her team in design control, new product development, and improvements to existing products.
The critical position requires a wide application of principles, theories, and concepts in the functional engineering field plus knowledge of all related manufacturing processes. This individual must have a strong technical background in the design of medical devices and the ability to guide the process of creative design from input requirements and sound experimental design.
- Functional management of catheter engineering group. Initiate and run flexible instrument development projects from concept to mfg. transfer. Generate hiring plans, budgets, and track spending.
- Develop and implement improvements to device designs and manufacturing processes and provide engineering support in the maintenance of company’s commercial product lines.
- Define requirements and specifications, plan and execute projects including budget, schedule and resources.
- Oversee the hiring, training, motivation, and development of staff. Mentor, challenge, and develop employees. Implement appropriate practices, structure and norms for the team.
- Ensure that intellectual property position of Company is enhanced by department activities.
- Prioritize project execution consistent with business needs.
- Work with each Program Manager to define program content and associated timelines and resource plans. Build, manage, track and communicate detailed project plans to achieve company goals. Communicate project status to senior management and other partners as needed.
- Organize design reviews across disciplines to ensure sound and coherent design.
- Maintain design history files to ensure compliance with FDA and international regulatory agencies design control regulations and to support the Regulatory team with necessary submissions and files.
- Review and approve test protocols according to external and internal standards and coordinate activities required to fabricate test parts and complete testing at Auris and/or outside testing laboratories.
- Analyze new technologies pertaining to endoscopes and other flexible instruments.
- 10+ years of experience and consistent demonstration of accomplishments in a dynamically more senior engineering and management positions. Leadership experience in catheter technology and medical device product development and launch of a disposable medical product.
- Bachelor’s degree in Mechanical Engineering, Materials Engineering, or a related Science. An advanced degree (M.S. or Ph.D.) in any of these fields is highly desired.
- Experience working in a multidisciplinary team setting for commercially available products and effectively communicate technical content to a broad audience.
- Demonstrated experience in effectively and clearly leading complex development programs from inception to commercial launch.
- Process development, IQ/OQ/PQ, and statistical analysis knowledge. Knowledge of six-sigma methodologies and design for manufacturability is desirable.
- Strong analytical and problems solving skills as well as demonstrated working knowledge of product development process.
- Experience working with ISO requirements, GMP guidelines, FDA regulations, specifically design control and manufacturing scale up.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Redwood City-
Auris Health, Inc. (6267)