Staff R&D Instruments Engineer (1 of 2)
- Redwood City, CA
Robotics & Digital Solutions , part of the Johnson & Johnson family of companies, is recruiting for a Staff R&D Instruments Engineer (1 of 2) , located Redwood City, CA
Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
The Staff R&D Instruments Engineer shall lead the design, development and manufacturability of robotic medical devices in accordance with the company's Quality System. This position will ensure that assigned products are designed to meet customer requirements as well as manufacturability and cost targets. The position requires a wide application of principles, theories, and concepts in the functional engineering field plus a deep understanding of other related subject areas. This individual's strong technical background in the design of medical device technology will drive the generation of creative design concepts from design inputs, to prototype those concepts, and evaluate those designs through sound experimental design. He or she shall have the capacity to prioritize project activities, technically lead a multi-functional design team, and empower others to reach objectives. This person will also provide technical mentorship to less experienced colleagues in the R&D group. This position shall be familiar with a broad array of engineering materials, manufacturing methods, and design standard methodologies.
Core Job Responsibilities:
- Collaborate cross-functionally on the innovation, technology development, and the creation of novel medical Instruments and systems, from feasibility prototype through product commercialization.
- Provide technical leadership and maintain the engineering staff's knowledge on technology and engineering areas associated with instrument and mechanism design.
- Lead conceptualization and assist in the preparation and review of patent applications.
- Act as liaison between R&D Team and external Industrial Design Groups
- Collaborate with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to assist in debugging and optimizing device performance.
- Drive definition of requirements for new products, creation of engineering specifications, and for verification and validation efforts.
- Develop project plans, schedules, and specifications for new product development.
- Estimate project costs and help create department budgets and records.
- Bachelor's degree in Mechanical Engineering is required; an advance degree is preferred.
- Minimum of 6 years of proven success in an engineering design role is required, experience in the medical device industry is preferred.
- Experience working in a multidisciplinary team setting bringing products from concept through market release and beyond is required.
- Balance multiple projects and have excellent time management skills
- Ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams is required.
- Strong analytical and problem-solving skills, as well as in-depth experience with product development processes.
- Expertise performing statistical and data analyses is highly preferred, experience using Minitab preferred.
- Sophisticated CAD experience is required, such as creating complex surface and solid models, assemblies, and detailed drawings is preferred. SolidWorks is highly preferred.
- A thorough understanding of engineering documentation standards and GD&T is required.
- Extensive experience specifying engineering materials for specific functional, performance, and/or aesthetic requirements (both polymer and metals) is required
- Extensive knowledge of mechanical design and experience with rapid product development and its application to single-use disposable medical devices with a record of commercialized products for high volume production. Experience with hand-held instruments is highly desirable.
- Comfortable collaborating and seeking optimum solutions with other engineering team members, as well as team members in adjacent subject areas such as UI/UX Design and Manufacturing Engineering.
- Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes. Familiarity with ISO 10991 standards and test methods, along with sterilization methodologies is preferred.
- A sound knowledge and understanding of DfX, DFM, or related principles is required.
- Ability to travel up to 10%, international and domestic, is required
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-150 Shoreline Dr
Auris Health, Inc. (6267)
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