Senior Product Development Engineer Surgical Robotics - OTTAVA
$109k - $174.8k6267-Auris Health Inc. Legal Entity
Job Location: Santa Clara, California, United States of America. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. We are seeking a Senior Product Development Engineer – Surgical Robotics (OTTAVA) within our Robotics and Digital (RAD) team. This role focuses on New Product Development (NPD) and New Product Introduction (NPI) of advanced surgical robotic systems. Key Responsibilities Collaborate with internal teams and external suppliers to plan, develop, qualify, and stabilize component, equipment, and manufacturing processes for NPD projects. Partner with R&D, Manufacturing, and Suppliers to implement robust manufacturing solutions using DFM, DFA, and Design‑to‑Cost principles. Conduct tolerance stack‑up, GD&T and FEA analysis to ensure designs are robust and manufacturable at volume. Drive cost‑effective technical solutions through design simplification, material optimization, and process improvements while maintaining quality and performance. Support formal design reviews by assessing technical feasibility, manufacturability, and cost trade‑offs to inform early decisions. Serve as liaison among R&D, Product Management, Quality, Manufacturing, and suppliers to embed manufacturing voice in design. Support Design Transfer activities for smooth and compliant transition into manufacturing. Apply engineering fundamentals, advanced manufacturing techniques, and statistical analysis to solve complex technical problems and establish new methods and standards. Lead or support PFMEAs, process characterization, and control strategies in compliance with GMP requirements. Oversee engineering builds and pilot runs, performing root cause analysis and driving corrective actions. Manage project deliverables and track component and design changes to minimize impact on assembly and manufacturing operations. Qualifications Education: Bachelor’s degree in Mechanical or Electrical Engineering (or related field) required; Master’s degree preferred. Experience: Minimum four (4) years in mechanical, electro‑mechanical, or opto‑mechanical engineering; experience with DFM/A for injection molding, machining, and optical equipment. Proficiency in 3D CAD (SolidWorks or Creo) and GD&T per ASME Y14.5. Strong understanding of cost implications on design requirements and manufacturing processes that meet product requirements. Experience with regulated medical device development processes and guidelines (21CFR820, ISO13485, ISO14971, IEC60601). Measurement systems analysis (e.g., GR&R) and statistical analysis (DOE, process capability) knowledge. Knowledge of equipment concept creation, review approval, build, runoff, FAT, software validation, IQ, OQ, and PQ road maps. Experience with PFMEA and SixSigma, plus preference for regulatory experience worldwide. Experience with cost engineering initiatives and managing complex design projects with financial focus. Knowledge of medical‑specific assembly technologies and supplier equipment base. Experience with manufacturing techniques such as laser welding, riveting, laser etching, soldering, pressing, joining, extrusion, over‑molding, coating. Ability to travel up to 30percent domestically or internationally; attendance required on-site. Preferred Skills Business Requirements Analysis, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Design Thinking, Feasibility Studies, Financial Competence, HSE Management, Lean Supply Chain Management, Mechanical Engineering, Problem Solving, Process Oriented, Product Design, Product Development, Project Management, STEM application, Technical Credibility, Technologically Savvy. EEO Statement: Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, veteran status or other protected characteristic. Benefits: Competitive salary of $109,000.00 – $174,800.00, eligibility for retirement and long‑term incentive programs, and standard company benefits as per company policy. #J-18808-Ljbffr 6267-Auris Health Inc. Legal Entity
$109k - $174.8k
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