Manufacturing Process Development Engineer

hace 4 semanas


Gasteiz Vitoria, Álava, España Te Connectivity Corporation A tiempo completo
Job Overview

The Process Development and Manufacturing Engineer plays a key role in driving the development and implementation of manufacturing processes for medical device products. This involves scaling up fabrication processes from prototype to high-volume manufacturing, ensuring Design for Manufacturability (DFM) and collaborating with global cross-functional teams to define a competitive manufacturing strategy.

Responsibilities
  • Drive the generation, implementation, qualification, and optimization of fabrication processes for complex polymer consumables.
  • Develop and own product requirement documents, test plans, validation and verification reports, PFMEAs, and Engineering Change Orders.
  • Utilize statistical process control for product development, validation, and manufacturing optimization.
  • Plan and implement measures to address technical gaps, risks, or failures within the organization.
  • Specify and implement new manufacturing equipment.
  • Maintain collaborative relationships with clients and ensure expected deliverables are met or exceeded within agreed-upon timelines and budget.
  • Ensure technological and manufacturing strategy alignment between R&D, PD, and Operations.
  • Collaborate with Manufacturing sites to proactively plan for and support product transfer.
  • Leverage lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows.
  • Obtain components, supplies, and equipment to support prototype assembly and conduct preliminary OEM vendor assessment and selection.
Requirements
  • Bachelor's Degree in Engineering, Manufacturing, or equivalent.
  • 5 or more years of industry experience in process development and manufacturing, preferably in Life Science or related industries.
  • Experience working within an ISO 13485 regulated cleanroom environment.
  • Advanced knowledge of general engineering tools, such as DoE, FMEA, QFD, etc.
Preferred Experience
  • Scaling up fabrication processes from R&D to manufacturing.
  • Experience in photolithography for mold generation, electroplating for nickel shim generation, DRIE on silicon, wet silicon and glass etching, sputtering, evaporation, soft-lithography, machining processes, metrology, and injection molding.
Skills
  • Strong team player.
  • Strong understanding of manufacturing transfer and process validation & scale-up.
  • Excellent experimental design, data analysis, problem-solving, and decision-making skills.


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