Opportunity to join a progressive Engineering team focused on Additive Process Optimization to facilitate future growth and world class performance. RESPONSIBILITIES : • Plant Product Engineering Lead for critical engineering studies that impact operational performance. • Develop sustainable Engineering initiatives to that facilitate operational KPI performance. • Creation, Development and implementation of plant wide initiatives that reduce cost and improve KPI performance. • Application of a prioritised approach in Lean Engineering toward achieving key opportunities in quality, service and cost. • Works with Engineering & SLT leaders to deliver of Operational KPIs. • 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) • Provision of technical leadership/guidance for the Process / maintenance Technicians and 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 handover as appropriate. • Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets • 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 • All other duties as assigned. QUALIFICATIONS/EXPERIENCE REQUIRED:
S enior Sourcing Manager, Global Metal Category Stryker are hiring a Senior Sourcing Manager, Global Metal Category to join our team in a permanent role. We are flexible regarding location as you will be part of a diverse global team, yet proximity to a global Stryker facility would be advantageous. Stryker is continuing to show unprecedented growth and we are looking for a candidate that aspires to set our future direction. This is a fantastic opportunity for a candidate with recognized Category Management experience to join our high-performing Metals Global Category Management Team where you can grow & develop your career. To support career growth, we have some flexibility regarding role grade/title based on securing the right candidate. The successful candidate for this position will be able to reap the benefits as you grow & prosper within the Stryker family. Who We Want:
Position Summary The Label & IFU Administrator will be responsible for the creation, approval and release of Product Labels as well as the content modifications and all necessary documentation associated with our Product Labels & Instructions for Use (IFU). Key Areas of Responsibility
Position Summary Verifies compliance to the European Union Medical Device Regulations (EU MDR) for Stryker products, ensuring fulfilment of regulatory obligations and timely market access in EU countries. Develops and applies basic knowledge and understanding of the RA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Key Activities & Accountabilities • Reviews technical documentation including labelling and instructions for use against EU MDR requirements and works with international manufacturing sites to resolve issues • Post finalised technical documentation and review checklists to a central repository • Facilitates RA flag release for EU MDR compliant products in relevant ERP systems • Reports compliance metrics and works with the EMEA RAQA team to plan and deliver documentation reviews to specified timeframes • Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the management and international manufacturing sites in a timely manner • Provide administrative support to the EMEA product registration team where required • Develop close collaboration with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product release in EU countries • Executes RA activities in line with defined procedures and processes • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation • Identifies opportunities for continuous improvement and supports those activities across RAQA • Performs based on established targets, KPIs and objectives for RAQA • Provides support to EMEA / Country RAQA teams as appropriate Education University degree in relevant field Experience 0-2 years’ experience Knowledge/Competencies • Project management and time management skills, writing, coordination, and execution of RA items • Support technical and scientific RA activities • With minimal supervision, performs work that is varied and that may be somewhat difficult in character, conferring with superiors on unusual matters • Undertake assignments that are broad in nature, requiring originality and ingenuity • Ability to take limited unreviewed action or decisions • Clearly convey information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors • Assists in the preparation of briefings and other information documents • Communicates information and advises on RA requirements to other departments and business units • Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organisation • Seeks out diverse ideas, opinions, and insights, and applies them in the workplace • Connects and relates well with people who think and act differently than oneself • Embraces scrutiny and accepts feedback as opportunity to learn and improve • Preparation of RA metrics for reporting purposes • High attention to detail and process consciousness • Strong IT skills, including Microsoft Office • Fluent in English
Competent Level Systems Professional Role focusing on Level 1, 2, 3 and 4 support items associated with an Applications Portfolio across the Ireland Campus. Acting as a Subject Matter Expert (SME) on related Systems and Architecture, this role will mentor and support less experienced colleagues in order to ensure delivery of solutions that meet business needs Provide the following levels of support associated with the system elements of Applications i.e. Database Training Certifications desirable Strong Knowledge is major scripting languages like .Net, C++, SQL, SQL Plus Knowledge of Microsoft Azure Cloud Environment desirable Understanding of Data Analytics and Analytics Tools preferred Strong understanding of FDA and Regulatory Quality and Software Validation Requirements e.g. GAMP. Relevant professional body qualification or accreditations (for example MCSE, CCNA, ISO/IEC 15288-2015) desirable but not essential. Executes tactically under direction and competently performs day to day activities and elevates more complex activities. High level of problem solving skills and a logical thinker. Very good written and verbal communication skills. Very good customer handling skills. Ability to remain calm under pressure. Team player with highly developed interpersonal skills. Self-motivated with excellent initiative and attention to detail. Excellent time management skills and ability to prioritise workload.
Senior Project Manager - Design to Value Role Summary:
Manager, NPI Additive (Patient Specific Solutions) This position is to manage the Patient Specific Solutions team that is to be put in place in 2021 to develop a Global Additive offering for PSS across the divisions. This individual will have responsibility for managing engineers tasked with the effective introduction of New products & technologies in line with divisional product portfolios. The individual will have ultimate responsibility for project & stakeholder management, people management and technical assessment of all assigned projects. They will successfully lead the team to deliver key programs or projects per associated timelines, quality requirements within budgetary constraints. Talents we are looking for: • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams. • Accuracy-oriented team leaders . Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting. • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed. • Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members. • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration. Responsibilities will include: If you are interested in this excellent opportunity please apply in confidence.
Will work within the QA Shared Services Manufacturing Transfer Team, responsible for quality related activities as it applies to Manufacturing Transfer, these include but not limited to the following:
Senior Product Design Engineer Stryker Cork Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Taking great pride in developing and engaging our employees, Stryker was named to Fortune’s “Top 100 Companies to Work For” for the fourth straight year in 2014 and a Gallup Great Workplace in 2013. We are currently seeking a Senior Product Development Engineer to join our Orthopedics division. This role will be based in Cork. Talents we are looking for: • User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives. • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision. • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to be ready for what’s next. • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions. Responsibilities: The Product Development Engineer will contribute and lead complex teams to advance assigned projects through the development process to market launch. Detailed responsibilities of the Product Development Engineer will include, but are not limited to the following: #LI-EN
As a Senior Scientist Biocompatibility/Toxicology you will be a Subject Matter Expert in a senior scientific role with ultimate authority to determine biological safety for T&E products. You will collaborate with Manufacturing, Quality, R&D, Regulatory Affairs as well as external regulatory bodies to drive state of the art in T&E products and processes. Your key responsibilities