Ethicon Endo Surgery Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Capital Equipment Engineer for our R&D Capital Life Cycle team located in Cincinnati, OH.
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 www.ethicon.com.
The R&D Capital Life Cycle team is responsible for Ethicon and Megadyne capital equipment - which deliver power and communication for our Energy devices. We support production, cybersecurity, design control, product obsolescence, and cost improvement opportunities within our Energy business. Our team focuses on a variety of topics from component development, system verification, software validation, external manufacturing/supplier support, as well as requirements management to meet the planned and unplanned needs of our business.
This position places an emphasis on working closely with multi-disciplinary engineering teams to develop sophisticated hardware and software designs. 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.
We are searching for a versatile, enthusiastic engineer who is ready to learn and grow in their career. After initial onboarding and with continued mentorship, the candidate will be responsible for:
- Act as a liaison between R&D, Product Management, Quality and Contract Manufacturing (CM) to ensure design changes for commercial product are executed appropriately for a manufacturing environment and sustaining corporate initiatives.
- Ensuring product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge within a matrixed organization partnering with new product development teams as well as external manufacturing.
- Leading and/or assisting in the development through the design, validation, and qualification of complex capital medical devices.
- Partnering with our supply base to provide electro-mechanical components and subassemblies that meet established cost, quality, and performance requirements.
- Collaborating with external manufacturing partners on processes including, but not limited to: PCBA manufacturing, high level assembly, component obsolescence, cable manufacturing, micro-electronics, wire harnesses, power supplies, LCD displays, rigid/flex circuits, and/or electrical test equipment.
- Managing project timelines and/or associated requirements in product development, sustainability, and/or continuous improvement efforts.
- Conducting and/or collaborating in technical design reviews of requirements, specifications, designs, etc.
- Minimum bachelor’s degree in engineering or science with at least (4) years of working experience with electro-mechanical equipment/systems.
Required Skills & Experience:
- Experience in one of more of the following areas:
- component development/qualification with experience in process characterization and measurement system analysis.
- manufacturing programming, equipment and fixturing design, and/or software validations.
- design for manufacturability in electro-mechanical systems.
- demonstrated experience of design, test and solving for medical safety and IEC EMC standards, such as IEC60601-1, IEC60601-1-2, IEC61000-4-6 or equivalent, for complex medical systems.
- Strong proficiency with lab test equipment including multi meters, oscilloscopes, and power supplies.
- Must be intellectually curious with the ability work independently and in groups.
- Must be highly organized to lead multiple projects/tasks simultaneously and optimally prioritize projects and tasks.
- Excellent communication & presentation skills with internal and external partners and engineering leaders.
- Must have work authorization in the United States at the time of hire and maintain ongoing work authorization during employment.
Preferred Skills & Experience:
- Advanced electro-mechanical component/sub-assembly development and/or external manufacturing & supplier management of electro-mechanical components/sub-assemblies.
- Advanced Degree preferred.
- Leadership and Technical certifications (e.g., CSSBB, etc.).
- Experience working in a highly regulated industry
- Knowledgeable about medical-specific assembly technologies, the equipment supplier base, and the capabilities of the suppliers
- Process Excellence Six Sigma knowledge or certification
- Demonstrated experience with any of the following: electro-mechanical assembly process and manufacturing technologies: PCBA assembly, cable assembly, High-Level Assembly (HLA), automated assembly, test development, automated vision inspection and IC programming.
- Knowledge of development/characterization/qualification/investigational techniques (process DOE’s, GR&R, IQ/OQ/PQ, Fishbone, etc.).
- Medical Device experience and/or associated standard compliance (ISO13485, IEC 62304, IEC 60601, etc.).
- Ability to employ DFM/A techniques, Lean Six Sigma process knowledge, and FMEA tools to drive product design or design transfer.
- This position is located in Cincinnati, OH and requires up to 10% travel (within the United States and Mexico)
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.