The Principal Mechanical Engineer, Instruments is directly responsible for the design and development of innovative instruments for minimally invasive procedures. This person must capable of designing complex and precision mechanisms, extruded and injection molded components, and other components and assemblies related to medical devices, as well as understanding materials selection to optimize mechanical performance and reprocessing durability. The engineer will provide technical leadership to the Instruments Engineering Department such as creating flexible catheter design solutions and failure analysis strategies.
Core Job Responsibilities:
The position requires a wide application of principles, theories, and concepts in the functional engineering field plus a working knowledge of other related disciplines. This individual must have a strong technical background in the design of medical device technology and the ability to generate creative design concepts from design inputs, prototype those concepts, and evaluate those designs through sound experimental design. The candidate must have the capacity to prioritize project activity, work effectively in a cross-functional team environment, and motivate others to reach objectives.
- Lead innovation, technology development, and the creation of novel medical Instruments and systems, from feasibility prototype through product commercialization.
- Generate concepts and solutions for new products as well as provide engineering support for existing products.
- Lead ideation and assist in the preparation and review of patent applications.
- Execute product development processes following governing standards to implement programmed-use and single-use devices and tools.
- Collaborate with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to assist in debugging and optimizing system 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 contribute to creating department budgets and records.
- Develop and improve manufacturing processes to pilot production level.
- Interface with external suppliers for component and process design, and assist the Instrument Team in maintaining adequate inventory of engineering and prototype materials.
- Provide technical leadership and maintain the engineering staff's knowledge on technology and engineering areas associated with instrument and mechanism design.
- Minimum fifteen years of experience in an engineering role in the medical device industry, with at least five of these in a senior or principal role.
- 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 preferred.
- Experience working in a multidisciplinary team setting bringing products from concept through market release and beyond.
- Proven ability to develop product development strategy, manage project goals and estimate deliverable timelines.
- Must have a demonstrated ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
- Must have strong analytical and problem solving skills, as well as in-depth experience with product development processes.
- Expertise using SolidWorks as a design tool, including creating models, assemblies, and detailed drawings.
- Extensive knowledge and proven track record of mechanical design and rapid product development and its application to reusable or reprocessable medical devices with a record of commercialized products for volume production.
- Comfortable collaborating and seeking optimum solutions with other engineering team members, as well as team members in adjacent disciplines of hardware and software engineering.
- Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Knowledge of six-sigma methodologies and design for manufacturability is desirable.
- Strong creative ability (as demonstrated by a number of patents) as well as IP knowledge.
- Previous start-up experience is a plus.