Process Engineer II

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 innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Work cross-functionally with EHS, product development, process technology, CoEs, facilities, quality, regulatory, planning, procurement to address process challenges, material 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.
• Lead & execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, ECR/ECO, and Engineering Drawings for equipment and processes.
• Conduct statistical process control (as necessary) analysis and trending of existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
• Develop hands-on product/process/equipment training programs.
• Respond to immediate escalations from manufacturing floor and escalate to leadership, as needed.

Requirements

• Bachelor’s degree in engineering or equivalent with 2-6 years of experience.
• Statistical process control tools desired (SPC, Minitab, other software).
• Leverage lean six-sigma tools and methodologies.
• Excellent organizational and English communication skills (oral & written).
• Positive, sound interpersonal, and employee development skills.
• Project management and process improvement experience desired.
• Validation and requalification experience desired.
• Cleaning validation experience is a plus.
• Knowledge in MS Office skills.
• Tools and equipment used: General office equipment, computers, printers, copiers, fax machines, telephone communication systems, ERP systems, CRM platforms, statistical analysis tools, project management software, QMS platforms.

Skills

• Statistical process control tools desired (SPC, Minitab, other software).
• Leverage lean six-sigma tools and methodologies.
• Excellent organizational and English communication skills (oral & written).
• Positive, sound interpersonal, and employee development skills.
• Project management and process improvement experience desired.
• Validation and requalification experience desired.
• Cleaning validation experience is a plus.
• Knowledge in MS Office skills.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

Pay Range: $71,300.00 - $97,750.00 USD

Schedule

Not specified

Qualifications

• Bachelor’s degree in engineering or equivalent with 2-6 years of experience.
• Statistical process control tools desired (SPC, Minitab, other software).
• Leverage lean six-sigma tools and methodologies.
• Excellent organizational and English communication skills (oral & written).
• Positive, sound interpersonal, and employee development skills.
• Project management and process improvement experience desired.
• Validation and requalification experience desired.
• Cleaning validation experience is a plus.
• Knowledge in MS Office skills.