Senior Process Engineer

NATURE & SCOPE OF POSITION

• Reporting to the Director of Engineering the primary responsibility of the Senior Process Engineer is to provide engineering expertise to optimize existing products and their manufacturing processes, including injection molding and extrusion.

GENERAL RESPONSIBILITIES & AUTHORITY

Sustaining Product Engineering

• Maintain products within Change Management system by initiating Change Request and Change Orders for existing products and maintaining the Device Master Records
• Modify and maintain existing Bill of Materials and production assembly instructions
• Maintain Bill of Materials and drawings for products.
• Review and approve injection molds (and other tooling) and plastic production parts
• Maintain labels for to ensure accuracy and completeness.
• Implement component changes across multiple products due to component design changes or supply constraints; assess and evaluate proposed change via change request and execute via change order, managing by work order requirements
• Prepare and manage Temporary Deviations, providing commercial notification for lots affected as required
• Work directly with Production personnel to improve assembly processes, tools and methods

Sustaining Process Engineering

• Lead Process Engineering activities for injection molding and extrusion manufacturing lines, including process design, operation, automation and statistical process control (SPC)
• Provide provide second level troubleshooting and line support to address day-to-day Production issues and implement robust permanent fixes
• Identify opportunities to improve productivity, quality, yield and reduce waste from manufacturing operations and drive associated improvements
• Manage, analyze and interpret data spanning materials characteristics, processing parameters, and production metrics to make insightful conclusions
• Specify optimal equipment process parameters and raw material specs to ensure ongoing process capability (Cpk) and final product spec conformance requirements are met
• Ensure SOPs, process and quality controls are clear and effective for Production
• Create assembly drawings for products as required according to SOP.

Product Quality Support

• Develop and maintain required QMS documents including work instructions and test protocols.
• Work with Purchasing and Quality to support quality remediation effects
• Investigate product recalls, complaints and non-conformances through appropriate engineering analysis/evaluations to reach accurate problem root cause(s) and provide effective corrective actions
• Support the Quality Management System through developing and maintaining procedures, records, forms etc. as required
• Participate in quality improvement projects as required

Value Engineering

• Support changes requested by Production and Supply Chain
• Identify and execute product-related cost savings projects through applying Value Engineering techniques, e.g. part or packaging materials equivalent substitutions or optimizing standard hours by moving products to more automated or efficient production lines
• Evaluate and implement outsource opportunities; develop specification packages for RFQs, interface with vendors for materials and quality requirements, evaluate samples, and create inspection documents
• Evaluate samples and prepare reports, liaising with Purchasing and Supply Chain
• Manage changes via change request/change order

Change Control

• Maintain the Change Control System for products by initiating Change Request and Change Orders for new and existing products
• Review BOMs
• Review assembly instructions for new products and maintain existing assembly instructions.
• Review extrusion set-up data for accuracy
• Review BOMs and drawings for all Extension Sets
• Review labels for Med-Rx and OEM products to ensure accuracy and completeness
• Liaise between Critical Suppliers and CHS to implement new product design and modifications to existing products

Miscellaneous

• Engages with team in a style that supports excellence, personal growth and mutual respect through communications and practices that promote employee involvement at all levels
• Oversee co-op students as required
• Ensure compliance to all company policies/practices including ISO, Health and Safety etc.
• Perform any other duties as required

KNOWLEDGE, EXPERIENCE & EDUCATION

• Post Secondary Degree/Diploma in science or engineering required
• Minimum three (3-5) years of Process, Manufacturing or Sustaining Engineering work experience in a regulated industry environment (e.g. pharma, medical, food, automotive or aerospace) required.
• Hands-on experience with injection molding and/or extrusion production lines preferred; hands-on experience maintaining and/or programming automated equipment is an asset
• Hands-on plastic component design and review
• Familiarity with ISO 13485 Quality systems and P. Eng designation are assets
• Must have good interpersonal skills to keep all lines of communication open within production level and management level and the ability to work as a team player
• Ability to work in a fast-paced environment

LANGUAGE SKILLS

• Must be proficient in written & spoken English.

TECHNICAL SKILLS

• Superior computer skills and familiarity with MS Office, ERP/MRP knowledge
• Strong Solidworks skills, particularly for plastic part design, are an asset.
• Excellent writing, communication, and organizational skills.
• Ability to work with lab equipment and other automated equipment used in production.