Senior Engineer, Advanced Operations - Cork, Carrigtwohill IDA Business & Technology Park Innovation Centre

Work Flexibility: Hybrid or Onsite

Role: Senior Project Engineer

Location: Instruments R&D Innovation Centre, Cork

Role: Permanent

Work Style: Hybrid.

Position Summary:

This role sits in the Advanced Operations (AO) team within Stryker Instruments. AO play a critical role in process development and new product introduction within Stryker, interfacing between R&D activities and manufacturing. AO team responsibilities include translating design requirements into manufacturing and process requirements, and specifying and validating the manufacturing process for either internal manufacturing or external manufacturing partnership.

This role, within the AO team, will focus on the process design, development and validation of new products to the market. The successful candidate will execute the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products. They will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.

Talents we are looking for:

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

Responsibilities will include:

•  Provide 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.

• Ensure 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.

• Support capital acquisition activity including equipment selection, procurement, installation and validation.

• Analyze equipment to establish operating data, conduct experimental test and result analysis.

• Participate in process review meetings.

• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with new product introduction or transfer.

• Review and approval of validation and other process or project documentation.

• Complete capability studies for in-process inspection and generate subsequent inspection documentation.

• Conduct MSA studies for new products and processes.

• Provide training for manufacturing team members.

• Ensure adherence to GMP and safety procedures. 

What you need:

• B.S in Mechanical Engineering or related engineering discipline.

• 2+ years of professional experience.

Preferred Skills:

• Manufacturing experience and/or basic knowledge of manufacturing processes, materials, product and process design.

• Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.

• Experience in an FDA regulated environment or regulated industry beneficial, but not essential.

• Strong communication skills with the ability to work effectively cross-functionally and externally as required.

• High level of PC Skills required.

• Excellent attention to detail.

• Ability to travel domestically and internationally.

Travel Percentage: 20%