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

Project Engineer

Job ID: 7381

THE COMPANY

Our client is a global leader in medical device manufacturing with constant growth, a positive work environment and very low turnover. Due to product transfers to their operation in Baja California, they are seeking a Project Engineer responsible for the new product introduction into manufacturing and maintenance of Surgical products. If you have experience in disposable medical device products, preferably invasive products, this is the right opportunity for you. 

THE POSITION

Incumbent organizes and manages projects and ensures projects are completed in a timely manner. Position reports to Director of R&D Engineer based in the USA.

The Project Engineering position will provide all aspects of Product Introduction into manufacturing and maintenance of the line until transfer to Sustaining Engineering. The candidate is a facilitator; is dynamic, driven, organized and meticulous; excels in project management; communicates with ease at all levels; thrives in an ambiguous environment and is adept at facilitating actions and resolving conflicts. Understands and is knowledgeable in key aspects of supply chain, planning, purchasing, manufacturing and inspection requirements as these relate to Product Introduction.

Apply Manufacturing Expertise to R&D Product Design:

  • As an integral part of the project team, provides design, manufacturing, supply, component reduction, timing and assembly expertise to projects
  • Required participation in DFMEA, User FMEA and responsible for PFMEA in coordination with suppliers or manufacturing plants
  • Ensure assembly instructions at manufacturing location are consistent with design intent, have all required inspections identified from FMEA or observation are implemented and validated
  • Train and assist new individual in process development, documentation, and process control related processes
  • Provide support to project management for sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples, other
  • Coordinate and provide packaging alternatives, samples and current plant options to Project Management
  • Apply DFM (Design for Manufacturing) principles to all new product designs, including cost analysis and manufacturing optimization activities as required
  • Managing operations-related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team

Develop and Implement Comprehensive Manufacturing and Sourcing Plan:

  • 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
  • Ensure all suppliers are established within approved supplier system including NDA(s), audit schedules, pricing structure and MSA’s are in place where required

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

  • Coordinate all product transference into pilot line and/or alternate manufacturing site including manufacturing plants
  • Work with manufacturing, and sustaining engineering to provide for pilot line acceptance, training, transference, validation and ongoing support
  • 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

The candidate is a facilitator; is dynamic, driven, organized and meticulous; excels in project management; communicates with ease at all levels; thrives in an ambiguous environment and is adept at facilitating actions and resolving conflicts. Understands and is knowledgeable in key aspects of supply chain, planning, purchasing, manufacturing and inspection requirements as these relate to Product Introduction.

  • Prefer Bachelor level degree in Engineering / Technology or equivalent experience in medical device operation, planning and new product introduction
  • At least 3 years minimum experience leading manufacturing within a medical device environment
  • Experience with introducing new products within the medical device field
  • Experience working with manufacturing suppliers, contractors, assembly personnel, MRP/ERP
  • Excellent communication, presentation and multi-functional departmental leadership
  • A comprehensive understanding of ISO, GMP and FDA regulations
  • Experience in the commercialization of surgical medical devices in U.S., globally is preferred.

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

  • Strong analytical and critical thinking 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 people skills with demonstrated leadership, organizational influence and decision-making competencies.
  • Proven ability to direct, lead and influence dotted line and shared service personnel.
  • Proficient in Microsoft Office, and MS project.
  • Adept at CAD  ideally Solidworks
  • Working knowledge of medical device development, sterilization requirements and techniques, medical device regulations, and implantable medical device design requirements
  • Large company experience working with mulitple departments and locations
  • Willingness to travel out of country as required 25-40%

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