What are the responsibilities and job description for the Senior Process Engineer position at Katalyst Healthcares & Life Sciences?
Oversee/facilitate the change management process and ensure all applicable deliverables are captured/documented to release injection molded components.
Update BOM, drawings, and manufacturing assembly procedures accordingly.
May facilitate the design or updates to existing production assembly fixtures.
Author protocols, facilitate/execute qualification activities, and report documentation.
Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.
Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
Interact with product design and development personnel to ensure that processes and designs are compatible.
May develop and conduct statistical analysis or recommend additions to document work.
Requirements:
Bachelor's degree with a minimum of 4 years of experience in a regulated environment, OR an advanced degree with a minimum of 2 years of experience.
Develop manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems.
Must be open to travel domestically or internationally to perform duties as required.
Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
This can include scouting and feasibility work, material selection, process and equipment selection, tooling/fixture and equipment installation, and assessment of inputs, outputs, and alignment to requirements.
Salary : $108,600 - $140,400
