Staff Consumables Engineer

Johnson & Johnson Innovative Medicine•Irvine, CA

3d•$109,000 - $174,800•Hybrid

About The Position

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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. We are searching for the best talent for a Staff Consumables Engineer in the R&D Consumables group based in Irvine, CA. The Staff Engineer in the R&D Consumables group contributes to development of innovative consumable technologies and products to solve customer problems and satisfy unmet patient needs. Works with minimal supervision to provide mechanical engineering and design services in the R&D engineering group. Develops concepts, designs and details for machines, tools, fixtures, and products. Assures successful execution of new product and process design, development, and transfer activities. Champions functional excellence in development and leads the implementation of the latest/best design technologies such as simulation, and rapid prototyping. May work on projects involving more than one engineering field and involving engineering teams from other functional areas. Leads small to medium sized projects.

Requirements

Bachelor’s Degree in Mechanical engineering, Biomedical, or a related subject area
6 years of related R&D engineering experience or equivalents (M.S.+5 yrs; PhD+4 yrs)
Has demonstrated Mechanical Engineering competency with full knowledge of industry practices and standards.
Possesses a strong technical knowledge and application of concepts, practices, and procedures, and experience preferably in Medical Devices.
Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
Reviews and authors technical reports for regulatory submission for product submissions.
Helps draft patent applications with innovative ideas, technical market support literature, industry presentations, and publications.
Works well with other engineers in a collaborative, fast-paced results-oriented environment.
Knowledge of CAD software for modeling and for reviewing and updating drawings is essential.
Must have experience in leading projects.

Nice To Haves

Graduate degree in Mechanical Engineering, Biomedical Engineering, or related subject area.
Experience in one or more of the following: Injection Molding, manufacturing, R&D in development of Ophthalmic Consumables and Accessories
Has a technical background in health care, medical devices, pharmaceutical, or similar industries.
Technical team leadership capability with strong self-motivation, project management skills, and demonstrated ability to lead a multi-functional team while optimizing resources to deliver project results.
Possess a successful track record of medical device product development from concept through launch.
Effective verbal/written communication and interpersonal skills including relationship management.
Experience leading root-cause and corrective actions utilizing the appropriate tools
Six Sigma Black Belt certification is preferred.
Microsoft Project knowledge & experience
Experience in supporting external innovation activities by providing technical guidance, and evaluation as required for potential acquisition or licensing.

Responsibilities

Implements sophisticated design concepts and ideas into working blueprints and drawings
Inspects and leads all aspects of testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.
Generates prototypes, evaluates and provides positive feedback on concepts and design modifications based on key stakeholder input.
Performs hands-on and simulated testing for design verification and test method development.
Conducts functional and performance testing of products to identify and define CTQs and ensure that the product and its components meet the required specifications.
Works with R&D, operations, marketing, regulatory and supply chain stakeholders to design for manufacturability and cost improvement strategies.
Designs and reviews components for plastic injection molding, extrusion, stamping, machining as required.
Experienced with 5 Whys, Fishbone (Ishikawa) diagrams, and Fault Tree Analysis to decompose failures to root causes.
Identifies issues and communicates status to peers and managers.
Able to analyze data using statistical tools and derive conclusions.
Leads efforts to generate, review, and approve drawings and design control documentation.
Leads efforts to generate, review and approve documentation for Test Systems and Validations of Test Equipments
Applies sound engineering principles and practices to the design and testing of medical devices.
Works with and provides oversight to suppliers on the design and procurement of components, tooling and fixtures for the design, testing, inspection or assembly of products.
Supports design control review meetings to ensure completion of required project goals, and coordinate activities with multi- functional team members on action items.
May receive technical guidance on the most unusual or complex problems but independently resolves and develops approaches to solutions.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year