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Sr Process Engineer - Exempt
Sr Process Engineer - ExemptLanceSoft • Irvine, CA, United States
Sr Process Engineer - Exempt

Sr Process Engineer - Exempt

LanceSoft • Irvine, CA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

We are seeking a highly skilled and experienced professional to join our team with a focus on medical device manufacturing. The ideal candidate will have a strong background in process engineering, particularly within the medical device industry, and will play a critical role in enhancing our manufacturing processes.

HM's Top Needs :

  • Previous medical device experience
  • Hands-on experience in manufacturing (preferably medical device)
  • Process validation experience

Education Required :

Science / Engineering Degree : Sr (BS, MS)

Years' Experience Required :

Sr (minimum 3-4 years)

Work Schedule :

40 hours a week, onsite 3-5 days / week in Irvine (two different buildings)

Responsibilities :

  • Provide technical and sustaining engineering support in a manufacturing area.
  • Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies.
  • Integrate equipment and material capabilities to meet process module target specifications.
  • Review product development requirements for compatibility with processing methods.
  • Lead the innovation, development, and optimization of new manufacturing concepts, processes, and procedures.
  • Develop manufacturing processes applicable to statistical process control.
  • Ensure processes and procedures are in compliance with regulations.
  • Formulate, deliver, and manage projects, working with stakeholders to achieve desired results.
  • Primary Responsibilities :

  • Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions.
  • Develop fixtures, tooling, and equipment.
  • Develop process specifications to ensure user needs are met.
  • Perform equipment and process characterizations and qualifications (IQ / OQ / PQ).
  • Manage required builds for new product development in a pilot or production setting.
  • Comply with applicable FDA and international regulatory laws / standards.
  • Preferred Qualifications :

  • Knowledge of processing materials associated with medical devices such as Polymers and Metals.
  • Hands-on experience with processes associated with medical manufacturing such as laser bonding and thermal bonding.
  • Experience with manufacturing line layout, capacity analysis, and line balancing.
  • Proficient with development and qualification of fixtures / tooling / equipment.
  • Experience working with outside OEM Suppliers in component development.
  • Experience with design and process FMECA, process validation, and process control.
  • Knowledge of design for manufacturability and lean methodologies.
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