Senior Engineer in R&D Programs Support ~CSS Medical Devices
Johnson & Johnson's Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Engineer in R&D Program Support for the Cardiovascular Specialty Solutions (CSS) companies based in Irvine, CA (preferred) or Irwindale, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Cerenovus, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
The Senior Engineer of CSS R&D Program Support serves as a key member in driving harmonization and efficiency in R&D operations of CSS business units. Providing leadership and technical supporting in R&D systems, design control process, project management and innovation.
- Execute ONE MD Harmonization objectives across the CSS business units.
- Working knowledge of design control process and ability to guide others through the process.
- Ensure compliance of design control with emerging standards.
- Ensure harmonization of R&D business practices with ONE MD.
- Change agent to drive change regarding enhancing practices such as Design to Value, moving to new Product Lifecycle Management Systems.
- Support NPD teams on enhanced project management framework for program success (Scorecards, risk registers, schedule contingency modeling, resourcing, lessons learned).
- Working knowledge of process excellence methodologies such as Six Sigma and Design Excellence, and Flawless Project Execution.
- Promote collaboration and innovation at cross company forums such as DTV summit or Innovation Summits.
- Accountable for efficient and compliant R&D operating processes to ensure portfolio milestones to reach more patients and restore more lives.
- Responsible for successfully migrating the CSS business to new systems for portfolio, project
- management and product lifecycle.
- Working knowledge of R&D Systems utilized for New Product Development process
- A minimum of a Bachelor's Degree and a minimum of four (4) years of related experience is required.
- Experience in design control is required.
- Knowledge in one or more of the following is preferred: FDA QSR 21 CFR 820 / ISO13485 quality system, Standard engineering principles/processes, Project Management, Process Management in Six Sigma or Design Excellence, Communication skills, Cross-functional partnership, Technical Writing.
- Experience launching new products to market from concept to launch preferred
- Experience within the Medical Device industry preferred .
- Subject Matter Expert in Design Control procedures and compliance with relevant regulations in Class II /III Medical Devices is highly preferred .
- PMP certification, Green Belt or Black Belt certification in Six Sigma or Design Excellence is preferred.
- This position is located in Irvine, CA (preferred) or Irwindale, CA and may require up 10% travel both internationally and domestically.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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