Engineer II, Process Engineering

About the role

The Process Engineer is responsible for understanding, optimizing, and sustaining manufacturing processes within a value stream. They leverage lean and six sigma tools and methodologies to improve processing, layout, workflow, assets, assembly methods, and workforce usage to enhance process efficiency. This role involves developing end-to-end process and product understanding, addressing lifecycle management, and sustaining engineering changes while ensuring compliance with corporate policies, FDA regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, and Canadian Medical Device Regulations (CMDR).

Responsibilities

• Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, and procurement to address process challenges, material changes, and lifecycle/sustaining changes.
• Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management, new product introductions, and more.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
• Conduct statistical process control analysis and trending of existing process parameters, inputs, and outputs to improve manufacturing yields, reduce scrap, and error-proof processes.
• Perform timely technical investigations, non-conformance reviews, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
• Complete projects to drive process, quality, reliability, and cost improvements using advanced technologies, lean six-sigma tools, and methodologies.
• Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with processes to ensure cost accuracy.
• Monitor performance metrics for value stream(s) and develop improvement actions to attain targeted Key Performance Indicators (KPIs).
• Develop hands-on product/process/equipment training programs.
• Participate in cross-functional process and product project teams, including product development, quality assurance, facilities, regulatory, and manufacturing.
• Complete other job-related duties as assigned.

Requirements

• Bachelor’s degree in engineering or equivalent with 0-2 years of experience.
• Experience with statistical process control tools (SPC, Minitab, or other software) is desired.
• Lean Six Sigma experience is desired.
• Excellent organizational and English communication skills (oral & written).
• Positive interpersonal skills and a focus on employee development.
• Project management and process improvement experience is desired.
• Proficiency in MS Office tools.

Tools and 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), and QMS platforms.

Pay

Salary range: $71,300.00 - $97,750.00 USD. Individual pay is determined by job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity, or other variable compensation.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, and business accident insurance.
• Group legal insurance.
• Savings plan (401(k)).