Senior Process Engineer I

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Think differently and challenge what’s possible. We’re looking for a Sr. Process Engineer to join our team.

Responsibilities

• Develop a cross-functional network with Environmental, Health, & Safety (EHS), product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, trial changes, and lifecycle and sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
• Initiate, develop, and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
• Leverage statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Perform timely technical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Ensure value stream(s) BOMs, routers, and work instructions to align with process and ensure cost accuracy from product transfer through product lifecycle.
• Complete process improvements actions to ensure performance metrics attain targeted performance.

Skills & Competencies

• A Bachelor’s degree in engineering or equivalent with 5+ years of experience; Master’s degree with 3+ years of experience.
• Experience with statistical process control tools required (SPC, Minitab, other software).
• Lean Six Sigma experience required.
• Demonstrate excellent organizational and English communication skills (oral & written).
• Sound interpersonal, and employee development skills.
• Project management and process improvement experience, PMP desired.
• Knowledge in enterprise resource planning, material resource planning, and MS Office skills.

Tools & Equipment Used

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

Physical Requirements

• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

Adverse Working Conditions

• Handling hazardous and biohazardous materials such as: Flammable and corrosive liquids, Compressed gases, Sharps, Medical waste.

Pay Range

$71,000.00 - $98,000.00 USD