JOB DESCRIPTION:The OpportunityThis position works out of our Ottawa, Ontario location in the Point of Care, Diagnostics division. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including Chemistry, Electrolytes, Hematology, Blood Gases, Coagulation, Endocrinology, Cardiac Markers, Neurology, and Informatics. As the Intermediate Engineer for Assembly Line 10, you'll have the chance to be a key contributor in ensuring manufacturing output, quality, and compliance of i-STAT cartridges. In this role you will be responsible for achieving all key performance indicators (KPI) for the Assembly Line, including Safety, Quality, Line Output, Line Yield, Material Use Variance, Overall Equipment Effectiveness (OEE), and Productivity.
What You'll Do - Monitor and action Line KPI's such as Cartridges per Hour (CPH), Overall Equipment Effectiveness (OEE), Line Yield, Output, Faults, and Downtime through collaboration with Operational, Technician, and Engineering stakeholders to resolve issues and ensure that daily / weekly / monthly performance targets are being achieved.
- Represent your line's performance at Tier 1 (Line Team) and Tier 2 (Cross Functional Assembly Team) Performance Huddles, escalating support requests.
- Work with Line Machine Operators to develop best practices for Line Operation to achieve KPI targets and standardize performance across the shifts.
- Support Line Operation and Maintenance through certification to develop subject matter expertise, guide improvement prioritization, and ensure achievement of production targets.
- Utilize Structured Problem Solving to drive to root cause on ongoing Performance and Quality issues and identify, develop, and implement robust and pragmatic solutions to avoid recurrence.
- Track and Trend Critical Process Parameters (CPP), Critical to Quality Attributions (CQA), Finished Goods performance, and Customer Complaints to ensure that Cartridge Assembly quality issues are adequately mitigated to limit bracketing and containment of outgoing cartridge lots.
- Drive stable and predictable quality through the establishment and maintenance of PFMEAs, Control Plans, Process Monitoring, and Error detection, proofing, and containment.
- Ensure the compliant state of Line through development/sustaining of systems for Good Record Keeping practices for all manufacturing data and sustaining of Validations, verifications, calibrations, and design changes associated with the Line.
- Ensure timely resolution of quality events (QRs, holds, complaints), driving for determination of root cause (investigation) and implementation of robust corrective actions or mitigations (CAPAs). Ensure process and equipment changes are validated or verified according to current quality standards.
- Lead projects of medium complexity. Support projects of high complexity.
- Lead resolution of medium and high impact QRs with support.
- Provide guidance, mentoring training to more junior staff.
Required Qualifications - The minimum level of education to perform this job competently is completion of a University (bachelor's or master's Degree) program in the Engineering or Science (Mechanical / Electrical preference).
- A minimum of 2 years of experience, preferably in high-speed automated manufacturing process engineering.
- Proven technical, creative, and implementation skills to contribute to continuous improvement of equipment / process design, quality, cost, and reliability.
- Ability to balance day-to-day production needs with completing longer term projects.
- Strong interpersonal, organizational, written, and verbal communication skills are mandatory.
- Analytical skills, creativity and innovative approach to problem solving.
- Ability to determine required analysis to make practical, objective decisions about the best solutions to problems.
- Effective at planning and coordinating, with excellent time-management skills.
- Ability to build and use an effective network of people inside and/or outside the organization to give and receive information and to accomplish work objectives.
- Strong interpersonal, communication and presentation skills; able to deal effectively with people on all organizational levels and work in a team environment across departments.
- Enthusiasm and propensity to continuous learning and experimentation.
Preferred Qualifications- Automated assembly processes, machine vision, seal and adhesion technology, product packaging, injection molded components, or laser cutting.
- ISO/FDA regulations, Current Good Manufacturing Practice 21 CFR Part 820, user requirements specification, process qualification, risk management/PFMEA methods, Quality / CAPA systems.
- Experimental design, data analysis, process control, statistical analysis, root cause analysis (6M's/ 5 Why's), six sigma.
- Software packages such as Solidworks, SQL, Minitab, SAS JMP, PLC/HMI Programming.
The annual base salary for this position ranges from $62,250.00 to $100,100.00 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.
The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Engineering
DIVISION:APOC Point of Care
LOCATION:Canada > Ottawa : 185 Corkstown Road
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
