Senior Process Engineer

Job Purpose

Leads clinical build line, owns process development deliverables such as process validation documentation, characterizes process, supports commercialization activity.

Key Responsibilities

• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Consistently generates innovative and unique solutions to meet department goals.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports and communicates results to the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Completes and manages complex Capital Equipment Request Authorizations (Client's).
• Leads cross-functional project teams.
• Leads in the identification, implementation, and management of production goals.
• Trains, develops, and/or provides work direction to operators, technicians, and engineers.
  
  

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

5+ years of experience

BS in engineering (Mechanical, Chemical, BioMed)

Additional Job Specific Requirements:

Knowledge of electropolishing

Experience with Keyance and Sensofar measurement technology