HireDiversity

Irvine, CA, US

STAFF SUSTAINING ENGINEER (CAPA)-4861120920

Description

Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Operations Engineer, Systems located in Irvine, CA.

ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.

The Staff Operations Engineer uses knowledge of scientific techniques and process excellence to support capital product sustainability through CAPA related efforts. The position will be responsible for conducting effective (e.g. timely, accurate, complete, etc.) investigations of identified issues with product components/materials, methods, processes, etc. in order to prevent, or eliminate/significantly reduce the probability of the problem from reoccurring. The position leads or participates in moderately complex projects requiring cross-functional support and participation. It will apply broad scientific and engineering knowledge independently and within a team to all phases of CAPA projects. These phases shall include, but are not limited to, root-cause analysis, risk assessment, designing and conducting investigative studies, analysis, formulation of business-effective solutions for the issue based on the analysis (including cross-functional impact of change), and implementation plans for achieving the desired long-term outcome.

The Staff Operations Engineer will have a strong background with standard engineering principles, theories, processes, concepts and techniques as well as the possible requirement of working knowledge of other product-related disciplines such as chemistry, microbiology, etc. Product focus is typically on complex, electro-mechanical capital equipment and related accessories, thus familiarity with systems engineering and reliability/maintainability is desired. The position exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, generally operates with latitude, and has demonstrated leadership abilities, is strongly process / documentation oriented, and has highly-effective communication skills (both written and oral).

The Staff Operations Engineer ensures effective CAPA investigations through the application of applicable techniques (e.g. Ishikawa diagrams, FTA, DoE, FEA, etc.), principles (e.g. statics & dynamics, stress & strain, thermodynamics, etc.), and methodologies (e.g. Design Excellence, etc.). Additionally, the position will take cross-functional input into consideration throughout the CAPA process including VOC, FMEA/SHUMAs, design review meetings, regulatory assessments, etc. During the course of the CAPA the position will evaluate progress and results and provide on-going updates to management and recommendations based on gathered technical expertise. The position maintains accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales. The Senior Operations Engineer, Systems will act as the intermediary between ASP and outside vendors and/or consultants as required to support the CAPA activity. Additionally, it also provides guidance and work direction to lower level engineers and related project team members. This position is located in Irvine, CA and requires up to 10% domestic travel.

Qualifications


The Staff Operations Engineer requires a BS Engineering degree with 7 years related experience or MS Engineering degree with 5 years related experience or a PhD with 2 years related experience. It is preferred that the successful candidate have a degree in Mechanical or Electrical Engineering. Regulated work environment industry experience is required (Medical device industry experience is preferred). Electro-mechanical equipment experience, strong documentation, strong root-cause analysis and CAPA experience required. The strong ability to direct other staff's activity in an indirect leadership role is highly preferred. The position is located in Irvine, CA and requires up to 10% domestic travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Relocation: Eligible
No
Travel:Yes, 10% of the time