Process Engineer 2, JJMT - Electrophysiology

Process Engineer 2

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Process Engineer 2 to join our R&D team in Irvine, California. This role is fully on-site at the Irvine location.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness.

Overview

Works on most assignments with instructions about the general results expected. May receive technical guidance on the most unusual or complex problems but independently determines and develops approaches to solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Makes an effort to analyze and solve areas that would reduce the cost of the product for financial benefits through materials and techniques of engineering. Engineer will exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Project tasks can include process development and equipment design, design for manufacturing, test method development, process validation, and creation of engineering documentation.

Key Responsibilities

Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Performs assignments designed to continue the development of professional knowledge and abilities requiring application of standard engineering techniques, procedures, and criteria in carrying out a sequence of related engineering tasks.
• Assignments have clear and specified objectives and require the investigation of a limited number of variables.
• Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
• Write or update work instructions, part specifications, validation protocols, test reports, routine reports and correspondence, develop, proofread and update technical documents as needed.
• Equipment design may incorporate concepts from mechanical, electrical, or controls engineering with assistance from cross-functional teams
• Assignments usually include one or more of the following:
  • Equipment design and development using Solidworks
  • Test of materials
  • Preparation of specifications
  • Process studies
  • Research investigations
  • Report preparations
  • Other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow areas of assignments
• May be assisted by a draftsperson or technician.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations/policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Practices company safety and quality policies and procedures. Actively requires conformance.
• Performs other duties assigned as needed.

Qualifications

• A Bachelor of Science Degree and generally requires 2-4 years of related experience and/or training; or MS Degree; or equivalent combination of education and experience.
• Good leadership and interpersonal skills
• Ability to travel as needed or requested.
• Experience with 3D CAD software systems such as SolidWorks.
• Ability to effectively work at all levels of management and to clearly present information and respond to questions groups of managers, peers, and customers.
• Technical knowledge of equipment and facilities maintenance systems as well as calibration standards, tooling processes and documentation control systems in a regulated manufacturing environment.
• Ability to use PC's and associated software (Microsoft Office/Microsoft 365)
• Ability to lead at least one major project.
• Knowledge of the principles, methods, tools and techniques of project management.
• Must possess an understanding of theoretical and practical fundamentals and applicable experimental engineering techniques.
• Must be able to successfully complete company/department training courses in manufacturing techniques.
• Ability to learn regulatory GMP requirements.
• Must be able to work with minimum supervision.
• Must have excellent reading, writing and communication skills in the English language.

Preferred Skills & Experience

• Knowledge of PLC, HMI, and other process control equipment
• Knowledge of Lean and Six Sigma tools and methodology
• Experience with embedded systems or microcontrollers
• Experience in the medical device or automotive/aerospace industry

Other

• This position will be located in Irvine, CA and may require up to 10% domestic travel.
• Weekend, overtime and/or off-site work may be required.
• The employee is required to wear special garments when working in a clean room environment.
• Position required to work with a variety of manufacturing equipment.
• While performing the duties of this job, the employee may work near moving parts and may be exposed to fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.
• The noise level may be loud.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $74,000 - $119,600. Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs.