Senior Engineer, Manufacturing

Description:

Position Summary

• Works with Engineering leaders to deliver business objectives
• Responsible for assisting in the development of a world class-manufacturing group that is proficient in process improvement and problem-solving manufacturing issues using Six-Sigma tools.
• Application of a prioritized approach in Value Centred Engineering toward achieving key opportunities in quality, service, and cost.
• Providing technical leadership on all product and process issues.
• Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Development and implementation of appropriate supporting documentation, SOPs, and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Leading technical improvements under the business’s Continuous Improvement Program (CIP).
• Transferring and implementing processes, either from development, or from another manufacturing facility.
• Provision of technical leadership/guidance for the Process / maintenance Technicians and other Manufacturing / Equipment Engineers on the team.
• Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented in accordance with Stryker New product Development Process.
• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
• Conduct Gauge R&R studies for products and new processes.
• Carry out structured problem solving.
• Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification, and operational handover as appropriate.
• Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day-to-day operating requirements, and in pursuit of achieving the business targets
• Fostering a work environment of continuous improvement that supports SYK’s Quality Policy, Quality System, and the appropriate regulations for the area they support, ensuring that employees are trained to do their work and their training is documented.
• Observing the Quality Management Systems requirements on site at all times
• Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers
• Undertaking, where appropriate, a Subject Matter Expert’s role for Regulatory Audit purposes
• Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• All other duties as assigned.

Qualifications Knowledge Skills

• B.S in Engineering, Science or business discipline required as minimum
• 3+ years’ experience of demonstrated engineering experience, ideally in medical devices
• Demonstrated engineering experience in new product / technology introduction in a regulated environment preferred.
• Flexibility essential with strong project management, Presentation, and written / verbal communication skills.
• Excellent PC skills (MS Excel, Access, PowerPoint, Project).
• Excellent attention to detail.
• Confident and effective decision maker, with a proven technical ability to deliver results.
• A spirit for driving the business forward – relentless drive to deliver results on projects, programs, and initiatives
• Quick learner that can understand manufacturing processes quickly, with a passion for automation and automated solution
• Accountability, Focus and Courage.
• Passionate about employee engagement, professional development, and delivery of business results