Principal Development Engineer

Principal Development Engineer Location Santa Clara, CA :

Ethicon Endo Surgery Inc., a member of Johnson & Johnson's Companies, is recruiting for a Principal Development Engineer, Advance Visualization; the preferred location is Santa Clara, CA, and alternate locations of Cincinnati, OH, or Raritan, NJ, will be considered.

Ethicon, part of J&J Medical Devices Companies, has made substantial contributions to surgery for more than 60 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 sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit .

Overview:

Our team of engineers, designers, and technical specialists are in the forefront of technology in the medical device industry. As the Principal Development Engineer, you will make vital contributions to the New Product Development (NPD) and NPI (New Product Introduction) pipeline and transform patient care through innovation. Our Development Engineering staff works with NPD teams and Suppliers to develop robust component designs and manufacturing processes that meet or exceed all product requirements.

The Principal Product Development Engineer is a key team member for our Advanced Visualization product pipeline will work closely with multi-disciplinary engineering teams to develop sophisticated medical devices. Candidates must be self-motivated, independent and have an eagerness to learn and work as a team, and a desire to thrive in a dynamic environment. In this position, you are expected to demonstrate sophisticated electrical and mechanical engineering knowledge, be able to independently resolve approaches to difficult technical problems and communicate broadly across engineering teams and associated management.

Key Responsibilities:

• Responsible for working with and supporting internal and external partners to plan, design, develop, qualify, validate, and stabilize component and equipment development process solutions for New Product Development (NPD) projects.
• Apply engineering principles, world-class manufacturing techniques, statistics, and judgment to resolve complex technical challenges and establish new methods, controls, and procedures.
• Lead discussions between the Design and Supplier to select and develop a robust manufacturing process using Design for Manufacturing (DFM), Design for Assembly (DFA), Design to Cost (DTC), Design for Metrology tools and associated documentation, including specifications, PFMEA, and Control Plans.
• Act as the liaison between the R&D, Product Management, and Quality as well as component & equipment suppliers and provide "voice of manufacturing" to ensure product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge.
• Lead and support Design Transfer to manufacturing activities.
• Implement development engineering standards to support continuous improvement initiatives.
• Promote a high level of effective communication across the working team as well as with stakeholders and leadership.
• Other duties as assigned.

Qualifications

Required:

• Minimum B.S. (Mechanical, Electrical, or other related Engineering field equivalent) and 10 years industry experience.
• Engineering experience in either electrical, electro-mechanical, opto-mechanical, or electro-optical products and components or equipment.
• Experience in Design for Manufacturing or Assembly (DFM/A) around injection molding, machining, and optical equipment.
• 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:

• Advanced Degree.
• Experience designing, developing, and testing the manufacturing of electro-mechanical, fiber, or laser equipment and systems, including test and process development.
• Knowledgeable about medical-specific assembly technologies, the equipment supplier 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.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .

This position's anticipated base pay range is $113,000.00 to $195,500.

For candidates in the San Francisco Bay area, $166,000.00 to $267,145.

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