LanceSoft
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
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.
- 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.
- 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.