(Senior) Process Engineer (m/w/d) Product Transfers - befristet auf 24 Monate

Location:

This role is a hybrid position, based out of our site in Freiburg Germany

Who we want:

This role is within the Product Transfer Organisation. The role contributes to the delivery of high impact, cost transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary.

Talents we are looking for:

• Goal-oriented orchestrators. People who can effectively coordinate and focus the work of peers toward an important goal, prioritizing to the right activities that lead to success.
• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
• Network builders. People who build connections with other teams and divisions and coordinate cross-functional collaboration.

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.