Senior Project Engineer NPI
Division: Trauam & Extremities
Location: Stryker Anngrove, Cork
Hybrid working model
Role Summary
Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety.
Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability.
Utilizes CAD or CAE systems to model new designs and produce detailed engineering drawings.
Key Areas of Responsibility
Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker new product development procedures.
Project manage the introduction of new capital equipment and support the associated qualification and validation activities.
Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space, ensuring optimum process flow and ensuring quality of process and product as defined in the appropriate operation and material specifications.
Assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
Support capital acquisition activities.
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
Conduct MSA studies for new products and new processes.
Provide training for manufacturing team members.
Ensure adherence to GMP and safety procedures.
Review and approval of validation documentation.
All other duties as assigned.
Qualifications
B.S in Mechanical Engineering or related engineering discipline with 2 or more years of 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 oriented 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.
Excellent attention to detail.
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