Johnson & Johnson Careers

Principal Operations Engineer

Irvine, California
Engineering (Generalist)

Job Description

Requisition ID: 4304181010

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 or follow us at

Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.

Position Description:

Advanced Sterilization Products, is recruiting for a Principal Operations Engineer for the Operations Engineering, Life Cycle Management Group, located in Irvine, California.

The Principal Operations Engineer to support existing products for sustaining engineering and life cycle management purposes will use multidisciplinary engineering knowledge to design and develop innovative products or components/subsystems in support of the company’s strategic plan. Uses knowledge of scientific techniques and process excellence to design and develop safe, effective and efficient processes in support of the company’s strategies, goals, objectives and product portfolio. Provides technical support and oversight to ensure continuity of supply. Leads and participates in complex projects requiring cross-functional support for successful execution. This position will also support the transition of newly design products to production for operations engineering support.

Key Responsibilities:

• Works under consultative direction to toward predetermined long-range goals.
• Works on unusually complex problems and provides solutions which are highly innovative and ingenious.
• Apply broad scientific and engineering knowledge to the development and improvement of existing products, associated processes, and manufacturing equipment. Ability to use and apply standard principles, theories and concepts in their field is required. A working knowledge of other related disciplines is also strongly desired.
• Work independently and lead cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for processes and manufacturing related issues. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Generally, operates with latitude and has demonstrated leadership abilities.
• Evaluate manufacturing processes / products and collaborates with R&D, NPI, LCM, QA, MFG RA, and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs. Utilize the application of six sigma and lean tools and methodologies.
• Design and develop troubleshooting guides, labeling (in collaboration with Labeling Group) and decision-making matrices to ensure the standard application of methods in the resolution of process/ manufacturing technical issues.
• Working with external suppliers and manufacturers for transition and support of products in production from a sustaining engineering standpoint.
• Provide technical training and guidance to manufacturing and engineering personnel.
• Ensure quality conduct of projects including design, data summary and interpretation, report and manuscript preparation and review compliance to applicable regulations. Evaluate progress and results against goals and objectives. Recommend major changes in procedures or objectives.
• Generate written reports and provide technical expertise to related projects.
• Maintain accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
• Provide technical support for outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
• Work out proposals and cost estimates of project/process related costs or cost improvements.
• Provide guidance and work direction to lower level engineers and related project team members.



Bachelor Degree or equivalent required, Engineering discipline preferred. Advanced degree preferred.

Experiences & Skills:

• Minimum 8 years of experience in engineering, operations or supply chain required
• Thorough knowledge of FDA and other regulatory guidance required
• Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems is required
• Ability lead cross-functional project teams required
• Demonstrated experience leading project teams preferred
• Experience supporting manufacturing improvements for consumable products as it relates to design and form preferred
• Injection molding, blow-fill-seal process experience preferred
• Injection molding mold design knowledge (i.e., mold flow analysis, gate and sprue location design) preferred
• Mechanical design and design control experience (i.e., 3D modeling, FEA, DFM/DFA, tolerance stack up analysis) preferred
• Experience in the Medical Device industry preferred
• Process Excellence/Six Sigma skills preferred
• Demonstrated skills in developing, writing, and executing cGMP-based process and equipment validations preferred
• Previous project management, six sigma training and tech transfer preferred
• Lean Manufacturing experience preferred
• Automated packaging and assembly equipment experience preferred
• Demonstrated written and verbal communications skills are required
• The ability to communicate technical objectives and content to a varied audience is required

Computer Skills:

• Proficiency in SolidWorks required
• Proficiency in Microsoft MS Office required
• Proficiency in MS Project preferred
• Proficiency in Statistical Analytical Software (i.e., MINITAB or Statistica) preferred
• Proficiency in AutoDesk Moldflow preferred


• Ability to travel up to 10% domestic and international required

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.

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
United States-California-Irvine-33 Technology Drive
Advanced Sterilization Products (ASP)
Job Function
Engineering (Generalist)
Requisition ID