US +1-619-427-2310 - MX +52-554-172-5801 barbachano@bipsearch.com

Process Engineer Plastics

Job ID: 7380

THE COMPANY

Our client is a global leader in medical device manufacturing who seeks an R&D Process Engineer (Plastics) responsible for leading and coordinating the process development activities to support new product developments, sustaining engineering efforts and design/manufacturing; other assignments may include work for other products within the company portfolio. The company has a positive work environment that promotes teamwork resulting in low turnover. 

If you have experience and knowledge of requirements on disposable medical device products, preferably invasive products, this is an opportunity for you. Project Engineer will organize projects and ensures completion in a timely manner. Position reports to Director of R&D Engineer based in the USA.

THE POSITION

  • Plans and leads process development activities including design, prototyping, testing (verification and validation) risk management/process FMEA, process characterization, and documentation.  Participate in the redesign of existing processes to improve quality, utilize automated production techniques, optimize process capabilities, and product improvements in a more cost-effective manner.
  • Provide technical expertise in developing new tooling, guidance in processing and troubleshooting.
  • Interface with product development and manufacturing to understand product requirements and establish design criteria for manufacturing processes.
  • Interact with suppliers to define an evaluate materials and processes needed for effective execution of process development activities. 
  • Interact with suppliers to debug problems with production parts processes and equipment.
  • Interface with procurement to obtain quotations, purchase components.
  • Advise other engineering personnel on technical aspects of product/process design, molding techniques and the validation of processes.
  • Interface with engineers, manufacturing, and lab technicians to design and develop new fixtures and tooling.
  • Support product related technical problems in engineering and manufacturing areas.
  • Develop comprehensive manufacturing strategy for all projects that will include alternate methods for component acquisition including timelines, costs, capital, expense, risk and recommendations
  • Responsible for validations, IQ/OQ/PQ, product production within agreed upon scope, budget, timeline and quality
  • Interface with suppliers and manufacturing when implementing new processes
  • Coordinate with SBU planning for initial and ongoing supply, safety stock, distribution management including shelf life, and alternate suppliers for critical components
  • In conjunction with Quality establish AQL levels for each component and incoming inspection criteria including location, method of measurement, consistent data recording, disposition

Coordinate Manufacturing at Manufacturing Plant(s) or Partner’s Site:

  • Coordinate all product transference into manufacturing plants and/or alternate manufacturing sites
  • Utilizes metrics to improve new production, introduction process and product quality, at launch and throughout life of the program.
  • Working with project management, ensure all components/documents are properly placed into SAP and Agile
  • Drives quality improvements by risk assessment/mitigation eliminating sources of defects in the design, new product introduction and manufacturing processes.
  • Drives continuous improvement in manufacturing process, product manufacturability and flexibility, and operations cycle time and quality.
  • Remain current with all internal and appropriate external developments and policies in related areas of activity
  • Establish SOP(s) where appropriate and initiate training, adherence to:
    • TMV(s) (Test Method Validation)
    • Real Time Aging retention, testing
    • V&V testing , including IQ/OQ/PQ and PPQ Documentation, lab notebooks
    • Support Engineering Evaluation of returned product when required.
  • Support D and D plans and Change Orders, technical reviews and implementation
  • Provide other department support as requested by immediate supervisor

THE CANDIDATE

  • Will have a Bachelor in Engineering
  • At least 5 years minimum preferably within a medical device company
  • Fluent in English and Spanish
  • Experience with introducing new products within the medical device field
  • Experience working with manufacturing suppliers, contractors, assembly personnel
  • Excellent communication, presentation and multi-functional departmental leadership
  • An understanding of ISO, GMP and FDA regulations
  • Must be a well-organized self-starter with attention to detail, and ability to follow written & verbal instruction, take initiative
  • Strong sense of urgency; takes initiative to drive work forward
  • Manage assigned projects and related activities, propose changes and effectively participate on cross-functional teams
  • Proficient in Microsoft Office Suite
  • Strong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs.
  • Willing to work varied hours to accommodate manufacturing plant business hours
  • Effective verbal, presentation and written communication skills.
  • Excellent interpersonal skills with demonstrated leadership, organizational influence and decision-making competencies.
  • Adept at CAD ideally Solidworks
  • Working knowledge of medical device development, medical device regulations.
  • Large company experience working with mulitple departments and locations
  • Some light travel may be required.

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