Process Engineer

12 hours ago

Tel Aviv NA Israel Inspire MD Full time ₪100,000 - ₪120,000 per year

A medical device company developing and manufacturing mechanical devices is seeking a talented Process Engineer to join our R&D and Engineering team. As a Process Engineer you will work collaboratively with cross-functional team to ensure our medical devices meet all functional, performance, and safety requirements.

Essential Duties and Responsibilities

  • Lead and support cross-functional teams through the product development lifecycle, with a focus on design transfer, documentation, and production readiness.
  • Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to ensure design for manufacturability (DFM) and design for assembly (DFA).
  • Develop and execute validation and verification protocols (IQ/OQ/PQ) in compliance with FDA and ISO 13485 standards.
  • Drive process development, including equipment selection, process flow design, and work instructions.
  • Manage and support change control processes including the creation and revision of engineering change orders (ECOs) and related documentation.
  • Support risk management activities (pFMEA, hazard analysis).
  • Coordinate with suppliers and contract manufacturers to ensure readiness for production ramp-up.
  • Identify and implement continuous improvement initiatives to optimize product quality, reduce costs, and improve manufacturing efficiency
  • Investigate complaints from the field

Requirements (Relevant Education/ Languages, Skills)

  • Bachelor's degree in mechanical or Biomedical engineering.
  • Minimum of 5 years of experience in process engineering, preferably within the medical device industry.
  • Strong knowledge of FDA regulations, ISO 13485, and GMP requirements.
  • Hands-on experience with process validation (IQ/OQ/PQ), statistical tools, and quality systems.
  • Proficiency in technical writing, with the ability to clearly document complex processes and procedures.
  • Certification in Six Sigma, Lean Manufacturing, or equivalent methodologies is a plus.
  • Strong communication and organizational skills, with attention to detail and a proactive approach.

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