Job Function: R&D Product Development
Job Sub Function: Biomedical Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Anasco, Puerto Rico, United States of America
Job Description:Johnson & Johnson Vision, Inc. is currently hiring a Materials Engineer, to join its dynamic team located in Anasco, PR.
The Engineer is directly responsible for leading multiple raw material and molding related projects for the manufacture of inter-ocular lenses (IOL) at our site. They will lead multi-functional project teams and ensure that projects are completed on time and within budget. The Engineer will be an integral member of the Materials Engineering team in Anasco, PR and be fully accountable for Business Continuity, Validations, Cost Improvement and Supplier Enabled Innovation/Process Changes. The candidate should be able to possess an ability to work with peers and collaborators to enable the delivery of strong results.
The candidate will possess a technical understanding of injection molding, polymer materials, validations and mold fabrication.
The role collaborates with key business partners including Procurement, R&D, Supplier Quality, Engineering, Operations, Quality Assurance, and Regulatory Affairs to deliver on objectives. This role entails working in a medical device environment and applying Materials and Engineering knowledge to deliver innovative solutions to the business, both internally and at external supplier manufacturing sites through feasibility and scale-up. They will act as an advocate for continuous improvement of technology and processes, minimizing lifecycle costs, and adhering to environmental policies and procedures.
Key Responsibilities:Accountable for molding/resin characterizations/qualifications, developing/updating the appropriate specifications and supporting regulatory submission documentation/inquires. This includes:
- Conducting risk assessments and leading detailed product / process design reviews
- Develop project and qualification plans to lead projects to meet timelines and budgets
- Apply appropriate statistical and validation techniques based on overall risk
Responsible for identifying, coordinating, planning, executing, and evaluating value improvement projects at key, strategic materials suppliers to ensure quality, and on-time delivery. This entails:
- Implementation of cost-effective manufacturing solutions to drive end-to-end manufacturing efficiencies in collaboration with procurement and strategic suppliers
- Responsible for technical direction of supplier changes in partnership with Supplier Quality
- Conduct feasibility studies to assess new technologies or process improvements
Qualifications:- Minimum of a Bachelor's degree in Plastics Engineering, Mechanical Engineering, Materials Science or equivalent engineering is required. Advanced degree (MS, PhD, MBA) is preferred.
- Relevant work experience is required.
- Ability to use and navigate AutoCad/Inventor is highly desirable.
- Candidate must speak fluent English
- Excellent written and oral communication skills required.
- Excellent interpersonal skills required.
- This position requires candidate to be onsite and is located Anasco, PR.
- Must have the ability to work on own initiative and be able to lead multiple priorities simultaneously requiring excellent organizational skills.
- Must be flexible, occasionally different work schedules are needed to support project needs.
- Achievement of Six Sigma/Green Belt/Black Belt accreditation is preferred.
- Experience/familiarity with an FDA-regulated medical device or pharmaceuticals industry is preferred.
- Experience with troubleshooting, non-conformances, validations is preferred.
- Occasionally, a project may require travel for support. This position may require up to 15% travel.
- Experience qualifying (Validation & Risk Assessments) materials or processes in automated manufacturing environment is desirable
- Experience with micro-molding, mold design or overall injection molding is preferred
- Working experience with external suppliers to include partnering internationally is preferred
Required Skills: Preferred Skills:Bioinformatics, Biological Engineering, Biological Sciences, Biostatistics, Data Reporting, Data Savvy, Design of Experiments (DOE), Detail-Oriented, Execution Focus, Feasibility Studies, Preclinical Research, Problem Solving, Process Oriented, Prototyping, Report Writing, Research and Development, Researching, SAP Product Lifecycle Management, Technologically Savvy
