Senior Product Development Engineer Surgical Robotics – OTTAVA

Johnson & Johnson RAD (Robotics and Digital) is seeking for a Senior Product Development Engineer Surgical Robotics OTTAVA for our Santa Clara Location.

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. Learn more at ( MedTechSurgery

Fueled by innovation at the intersection of biology and technologyweredeveloping the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a teamthatsreimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovasculardiseaseand cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at team of engineers designers and technical specialists is at the forefront of innovation in the medical device industry. As a Senior Product Development Engineer you will play a critical role in the New Product Development (NPD) and New Product Introduction (NPI) pipelinedriving solutions that translate cuttingedge technology into meaningful improvements in patient care. The Development Engineering team works closely with crossfunctional partners and suppliers to deliver robust component designs and manufacturable processes that meet or exceed all product and regulatory requirements.

In this role you will serve as a key technical contributor collaborating with multidisciplinary engineering teams to develop complex highly regulated medical devices. Seniorlevel expectations include taking ownership of design elements leading technical problemsolving efforts and influencing design decisions across functions. You are expected to apply advanced electrical and mechanical engineering expertise independently resolve complex technical challenges and proactively identify risks and opportunities throughout the development lifecycle. Strong communication skills are essential as this role requires effective collaboration across engineering teams suppliers and associated management to drive alignment and execution in a fastpaced dynamic environment.

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 DesigntoCost principles.
• Conduct tolerance stack-up GD&T and FEA analysis to ensure designs are robust and manufacturable at volume
• Drive costeffective technical solutions through design simplification material optimization and process improvementswithout compromising quality or performance.
• Support formal design reviews by assessing technical feasibility manufacturability and cost tradeoffs to inform design decisions early.
• Serve as the liaison between R&D Product Management Quality Manufacturing and suppliers ensuring the voice of manufacturing is embedded in product design.
• Support Design Transfer activities to enable a 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 to assembly and manufacturing operations.

Qualifications:

Education: A minimum of a Bachelors degree and/or equivalent University degree is required; a focused degree in Mechanical or Electrical Engineering field or a related field is preferred. An advanced degree Masters is preferred.

Required

• Minimum four (4) years of relevant professional work experience
• Engineering experience in either mechanical electro-mechanical or opto-mechanical and components or equipment.
• Experience in Design for Manufacturing or Assembly (DFM/A) around injection molding machining and optical equipment.
• Proficiency in 3D CAD (SolidWorks or Creo) and GD&T per ASME Y14.5
• Technical Knowledge: Strong understanding of cost implications on design requirements alongside broad engineering knowledge in developing and implementing manufacturing processes that meet or exceed product requirements.
• Experience working closely with external or third-party suppliers.
• Knowledge and demonstrated application of regulated medical device development processes standards and guidelines including but not limited to 21 CFR 820 ISO 13485 ISO 14971 and IEC 60601.
• Measurement Systems Analysis experience (e.g. GR&R).
• Statistical Analysis knowledge (e.g. Design of Experiments (DOE) Process Stability/Control/Capability) and PFMEA.
• Understand equipment concept creation review approval build runoff FAT software validation IQ OQ and PQ road map requirements.
• Proven interpersonal and communication skills with the ability to work successfully in a team environment.
• Strong technical communication skills and proven ability to work independently.

Preferred:

• Understanding of regulatory requirements regarding the design build and release of medical devices worldwide
• Experience designing developing and testing the manufacturing of electromechanical fiber or laser equipment and systems including test and process development.
• Experience in Cost Engineering: Demonstrated experience in leading cost engineering initiatives along with a solid track record of managing complex design projects with a focus on financial performance and strategic cost reductions.
• Knowledgeable about medical-specific assembly technologies the supplier equipment base and the capabilities of the suppliers.
• Process Excellence Six Sigma knowledge or certification.
• Test methods development (TMD) & Test methods validation (TMV) experience.
• Experience with one or more of the following: laser welding riveting laser etching soldering pressing joining extrusion over molding coating and/or design for assembly experiences.

Other:

• May require up to 30% of domestic and/or international travel to other sites and locations
• The attendance policy required for this role is fully onsite.