Job Title

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 EngineeringMaintain products within Change Management system by initiating Change Request and Change Orders for existing products and maintaining the Device Master RecordsModify and maintain existing Bill of Materials and production assembly instructionsMaintain Bill of Materials and drawings for products.Review and approve injection molds (and other tooling) and plastic production partsMaintain 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 requiredWork directly with Production personnel to improve assembly processes, tools and methods Sustaining Process EngineeringLead 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 fixesIdentify opportunities to improve productivity, quality, yield and reduce waste from manufacturing operations and drive associated improvementsManage, analyze and interpret data spanning materials characteristics, processing parameters, and production metrics to make insightful conclusionsSpecify 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 SupportDevelop and maintain required QMS documents including work instructions and test protocols.Work with Purchasing and Quality to support quality remediation effectsInvestigate product recalls, complaints and non-conformances through appropriate engineering analysis/evaluations to reach accurate problem root cause(s) and provide effective corrective actionsSupport the Quality Management System through developing and maintaining procedures, records, forms etc. as requiredParticipate in quality improvement projects as required Value EngineeringSupport changes requested by Production and Supply ChainIdentify 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 linesEvaluate and implement outsource opportunities; develop specification packages for RFQs, interface with vendors for materials and quality requirements, evaluate samples, and create inspection documentsEvaluate samples and prepare reports, liaising with Purchasing and Supply ChainManage changes via change request/change order Change ControlMaintain the Change Control System for products by initiating Change Request and Change Orders for new and existing productsReview BOMs Review assembly instructions for new products and maintain existing assembly instructions.Review extrusion set-up data for accuracyReview BOMs and drawings for all Extension SetsReview labels for Med-Rx and OEM products to ensure accuracy and completenessLiaise 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 levelsOversee co-op students as requiredEnsure compliance to all company policies/practices including ISO, Health and Safety etc.Perform any other duties as requiredKNOWLEDGE, EXPERIENCE & EDUCATION Post Secondary Degree/Diploma in science or engineering requiredMinimum 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 assetHands-on plastic component design and reviewFamiliarity with ISO 13485 Quality systems and P. Eng designation are assetsMust 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 playerAbility to work in a fast-paced environmentLANGUAGE SKILLS Must be proficient in written & spoken English.TECHNICAL SKILLS Superior computer skills and familiarity with MS Office, ERP/MRP knowledgeStrong 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.