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Principal Mechanical Engineer, R&D
1 month ago
We are seeking a highly skilled and experienced R&D Principal Engineer specializing in Mechanical Design for ophthalmic surgical instrumentation at J&J Surgical Vision located in Irvine, CA.
Key Responsibilities- Lead the mechanical design and development of advanced ophthalmic surgical instruments, from conceptualization to final product realization.
- Collaborate closely with surgeons and their staff, product managers, industrial designers, and engineers from various disciplines to define project requirements, specifications, and objectives.
- Utilize CAD software and other relevant tools to create and evaluate detailed mechanical designs, 3D models, and engineering drawings.
- Provide expertise in relevant engineering standards and practices, such as GD&T and tolerance analysis.
- Conduct feasibility studies, engineering calculations, simulations, and analysis to evaluate the performance, reliability, and safety of initial designs and prototypes.
- Guide and mentor other engineers, providing technical direction and ensuring adherence to project timelines and budget constraints.
- Drive innovation and research efforts to identify and incorporate new technologies, materials, and design concepts that enhance product performance and usability.
- Collaborate with cross-functional teams to conduct design reviews, risk assessments, and regulatory compliance activities in accordance with industry standards and regulations.
- Bachelor's Degree in Mechanical Engineering or a related engineering/science field with 10 years of directly related experience or equivalent.
- Advanced degree preferred.
- Proven track record of successfully leading and delivering complex mechanical design projects from concept to commercialization.
- Understanding of surgical system equipment architecture and the design of critical subsystems and single-use consumable and reusable instrumentation to flawlessly interface with the system.
- Ophthalmic surgical procedure knowledge (Cataract, Vit-Ret, etc.).
- Proficiency in using CAD software (SolidWorks) to create and evaluate intricate mechanical designs.
- Strong knowledge of relevant industry standards, regulations, and quality management systems (ISO 13485, FDA regulations, etc.).
- Excellent problem-solving skills, with the ability to apply engineering principles to overcome technical challenges.
- Strong leadership and communication skills to effectively collaborate with cross-functional teams and guide a team of other engineers.
- Knowledge of materials, manufacturing processes, and machining techniques relevant to medical device design, including injection molding.
- Familiarity with design for manufacturability (DFM), design for assembly (DFA), and design for reliability (DFR) principles.
- Experience with risk management processes (ISO) and demonstrated attention to detail in ensuring safety and compliance in designs.
- Strong analytical skills and ability to conduct feasibility studies, perform engineering calculations and simulations, and conduct analysis to evaluate design performance.
- Experience and proficiency using six-sigma statistical tools to solve problems.
- Proficient in Failure Mode Effects Analysis and Risk Management application to medical devices.
- Experience with supplier selection and development.
