Senior Process Engineer

Katalyst HealthCares and Life Sciences; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in health and life sciences seeks an experienced professional to oversee change management and optimize manufacturing processes. The role involves collaboration with design teams and requires a strong background in regulated environments. Candidates must be willing to travel domestically and internationally.

Qualifications

• Minimum 4 years experience in a regulated environment or 2 years with advanced degree.

Responsibilities

• Oversee change management process and document deliverables.
• Update BOM, drawings, and manufacturing assembly procedures.
• Lead innovation and optimization of new manufacturing processes.

Skills

Change Management

Statistical Analysis

Process Optimization

Education

Bachelor's degree

Advanced degree

Job description

Job Responsibilities

1. 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.
2. Oversee / facilitate the change management process and ensure all applicable deliverables are captured / documented to release injection moulded components.
3. Update BOM, drawings, and manufacturing assembly procedures accordingly.
4. May facilitate the design or updates to existing production assembly fixtures.
5. Author protocols, facilitate / execute qualification activities, and report documentation.
6. 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.
7. Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
8. Interact with product design and development personnel to ensure that processes and designs are compatible.
9. May develop and conduct statistical analysis or recommend additions to document work.
10. Lead the innovation, development, and / or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.
11. 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.
12. Develop manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems.
13. Must be open to travel domestically or internationally to perform duties as required.