Staff Engineer - Product Transfer

Work Flexibility: Hybrid

WHAT YOU WILL DO:

As a Staff Engineer you will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity. You will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. 

As the Staff Engineer, you will build productive internal and external working relationships and may periodically provide guidance and train other team members.

ADDITIONAL RESPONSIBILITIES INCLUDE:

• Provide engineering support for all transfers globally, (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker), ensuring that all activities are completed and documented in accordance with the Stryker procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
• Enable successful completion of Product transfer to achieve its quality, cost and time requirements
• Be able to identify Product Transfer quality risks/gaps and provide solutions to correct
• May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
• Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers.
• Complete capability studies & MSAs for in process inspection and generate subsequent Inspection documentation.   
• Provide training/ guidance for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.
• All other duties as assigned.

What will you need

• Based on a successfully completed engineering degree (automation technology, process engineering, electrical engineering, mechanical engineering, medical technology, industrial engineering or similar), you ideally have 8 or more years of professional experience in the field of process development and/or process optimization.
• While working with a wide range of interfaces, your good communication skills, your open and positive nature as well as your committed and independent way of working.
• 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.  
• Excellent 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. 
• Individual is willing to travel occasionally for business purposes.