Senior Project Engineer Role
We are seeking a highly motivated and experienced Project Engineer to join our team at Stryker Instruments.
About the Role:
The successful candidate will be adept at working under pressure and in collaboration with cross-functional teams, applying innovative engineering approaches to streamline product development while maintaining compliance with regulatory standards and cost objectives.
* Application of a prioritised approach in Value Centred Engineering toward achieving key opportunities in quality, service and cost.
* 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.
* 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.
Your Key Responsibilities:
* B.S in Mechanical Engineering or related engineering discipline with up to 2 years' experience
* Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
* The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
* Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
* Innovative thinker - should be able to envisage new and better ways of doing things.
* Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
* Good knowledge of manufacturing processes, materials, product and process design.
* Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
* Experience in an FDA regulated or regulated industry beneficial.
About Us:
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Requirements:
This role requires a B.S in Mechanical Engineering or related engineering discipline with up to 2 years' experience. The ideal candidate will be a self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
The individual should enjoy working in a fast paced, dynamic and results orientated team environment. Excellent interpersonal skills are essential, with the ability to express ideas and collaborate effectively with multidisciplinary teams.
An innovative thinker who can envision new and better ways of doing things is also essential. Excellent analytical skills, with the ability to plan, organise and implement concurrent tasks are required.
A good knowledge of manufacturing processes, materials, product and process design is necessary. The ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing is also required.
Experience in an FDA regulated or regulated industry is beneficial.