Auris Health, Inc., part of the Johnson & Johnson family of companies, is transforming 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. Learn more about Auris Health at https://www.aurishealth.com/.
The Risk Management Manager, Robotics will be responsible for overseeing a team of risk management engineers to provide risk management support. The ideal candidate should have experience in managing a team of Risk Management Engineer supporting new product development and/or Sustaining Engineering of complex electro-mechanical, software-controlled systems for medical applications to ensure robust product design that enable delivery of compliant, high-quality product to the customers. This individual will work with various other functions in the company like Quality System (Complaint handling, Change control, and CAPA), Clinical/Medical, Regulatory Affairs, and others.
In this role you will:
- Provide guidance and leadership to the entire company for the application of risk management activities within the framework of regulatory and applicable international standard requirements.
- Ensure that RMF (Risk Management File) is established and maintained whenever there is any update required on the Risk Management deliverable items within the RMF generated from various sources.
- Provide guidance and mentoring to Quality Engineers, and other product development team members in the area of Risk Management application in product and process development
- Interact and form constructive working relationships with all levels of leadership within Quality, Research & Development, Regulatory, and Operations organization.
- Utilize coaching and facilitating skills with program/project shareholders to provide training across the entire company on the proper risk management application based on Risk Management SOPs.
- Implement complaint handling group RM assessment on the complaint and perform updates on the risk management file as appropriate.
- Support the Risk Management Process per ISO 14971 and provide leadership in utilizing ISO14971 Hazard Analysis as a Design for Quality tool
- Provide guidance/direction on the FMEA application based on IEC 60812 standards as they relate to the new product development and sustaining engineering activities of electromechanical medical devices.
- Assist in various projects and other duties as assigned.
- A minimum of a Bachelor’s degree in Science, Engineering, or a related technical field required.
- A minimum of 8 years of relevant Quality Engineering or R&D Engineering experience including Risk Management experience required.
- This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485).
- Experience in Medical Device Risk Management standard of ISO14971 and IEC60812 required.
- Preferred experience with complex electro-mechanical device with embedded software, capital equipment, and consumable devices.
- Experience with engineering management is preferred.
- Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member as well as in leadership role.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Advanced analytical and problem-solving skills required.
- Ability to guide and mentor on Risk Management in Product Development required.
- This position will be based in Redwood City, CA and may require up to 15% travel.
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
The physical demands described
here are representative of those that must be met by an employee to
successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to attend meetings, observe in labs or the manufacturing area. The employee frequently is required to sit, stand or walk.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.
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)