Senior Process Engineer - 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.