Stryker Carrigtwohill, County Cork, Ireland
Overview
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Stryker Carrigtwohill, County Cork, Ireland
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Responsibilities
Ensure quality of process and product as defined in appropriate OS and material specifications.
Ensure GMPs and system safety.
Participate in FMEA, Control Plan, SOP and PPAP generation associated with product transfers and scale ups.
Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
Provide training for manufacturing team members.
Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
Validation, appraisal and support of coating suppliers, machining suppliers and raw material suppliers (e.g., Forgings, titanium).
Communicate and participate in system and process troubleshooting with support team members and external agents.
Lead and participate in cross-functional and cross-divisional process improvement initiatives.
Provide engineering support for new product and new process introduction, ensuring 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 and application and development of statistical tools for continuous improvement projects.
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
Level 8 Degree in Engineering, Science or related discipline or equivalent technical experience.
0-2 years' experience in an Engineering role, ideally production, R&D, biomedical.
Business understanding of operations and their impacts essential.
High level of PC and analytical skills required.
Flexibility essential.
Strong communication skills with both internal and external stakeholders.
Self-starter with demonstrated efficient work methods, analytical and problem solving skills and ability to handle multiple tasks in a fast paced environment.
The individual should enjoy working in a dynamic and results motivated team environment.
Experience in an FDA regulated or regulated industry is beneficial.
Experience in a Six Sigma and Lean Manufacturing environment with proven improvement results is beneficial.
Green or Black Belt Six Sigma qualifications are beneficial.
Seniority level
Associate
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Appliances, Electrical, and Electronics Manufacturing
Industrial Machinery Manufacturing
Medical Equipment Manufacturing
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