Staff Engineer, Advanced Operations

Executes 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.

Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.

The individual will be responsible for project & stakeholder management and will successfully lead an engineering team to deliver key programmes or projects per associated timelines, quality requirements and budget

Your key responsibilities

• 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.
• Will 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 activity from specifying equipment, contract negotiation, Installation and validation.
• Will analyse equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.   
• 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.
• Assume overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling and closure of a project
• Lead  New Product, Process and Technology implementation initiatives while tightly managing project spend on capital & expense budgets
• Define and clarify project scope while developing and maintaining the project schedule. Ownership for managing and reporting project progress
• Responsible for identifying, monitoring, and appropriately managing project risk and liaise with broader AO team on common NPI issues and resolutions
• All other duties as assigned.

What are we looking for?

• B.S in Mechanical Engineering or related engineering discipline with 2 or more years’ experience Knowledge of New Product Introduction is desirable
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment would prove beneficial
• The individual should enjoy working in a fast paced, dynamic and results orientated team 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.
• High level of PC Skills required.
• Excellent attention to detail.

This role will be posted for a minimum of 3 days.