This role is within the Product Transfer team

What you will do:

• Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures.  

• Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment. 

• Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures. 

• Analyse equipment to establish operating data, conduct experimental testing and result analysis.

• Mentor or be a mentee for/with others on functionally related topics. 

• Ensure quality of process and product as defined in the appropriate operation and material specifications. 

• Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific processes, testing and inspection protocols. 

• Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers. 

• Ensure adherence to GMP and safety procedures. 

• Review and approve of validation documentation. 

• All other duties as assigned. 

Minimum Qualifications, Knowledge, Skills (Required):

• Bachelor’s degree in an engineering discipline preferred with already gained experience in a manufacturing or project environment

• Proven track record of working in a team-based environment. 

• Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas. 

• Innovative thinker - should be able to envisage new and better ways of doing things. 

• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. 

• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design. 

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

Preferred Qualifications (Desired):

• Experience in Medical Device industry

• Experience in an FDA regulated or regulated industry

• Experience of process/ product validations, statistical methods, Process mapping,

• Continuous Improvement and Project / Process Improvement related experience

• Green or Black Belt 6 Sigma qualifications

• Experience in an FDA regulated or regulated industry beneficial. 

Additional info:

This is a fixed-term role for 18 months.