Job Title:
Senior Project Engineer, NPI
----------------------------------- Job Description:
We are seeking a highly skilled Senior Project Engineer to join our team. As a key member of the Trauma & Extremities team based in Cork, you will be responsible for executing New Product Introductions (NPIs) with external suppliers and our Stryker China facilities.
Your primary focus will be on executing assigned project elements with an emphasis on manufacturing systems and procedures. You will employ project management best practices to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Key responsibilities include providing engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures. You will also ensure quality of process and product as defined in the appropriate operation and material specifications.
Additionally, you will assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements. You will work with quality engineers to develop component-specific testing and inspection protocols.
Other key responsibilities include supporting capital acquisition activity from specifying equipment, contract negotiation, installation, and validation. You will analyze equipment to establish operating data, conduct experimental tests, and result analysis. You will lead and/or participate in process review meetings.
You will participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches. You will complete capability studies for in-process inspection and generate subsequent Inspection documentation. You will conduct MSA studies for new products and new processes.
A key aspect of this role is providing training for manufacturing team members and ensuring adherence to GMP and safety procedures. You will also review and approve validation documentation and perform other duties as assigned.
----------------------------------- Required Skills and Qualifications:
* 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
* Ability to express ideas and collaborate effectively with multidisciplinary teams
* Innovative thinker with good analytical skills, ability to plan, organize, 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
* High level of PC skills required
* Excellent attention to detail
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