Manufacturing Design Engineer

The Role   

We are seeking a Manufacturing Design Engineer to join our R&D team to take responsibility for design for manufacturing and assembly activities for new medical devices.  The ideal candidate should have 5+ years’ experience designing consumer and/or medical devices for high volume manufacturing.  Experience with ISO regulated quality management systems (9001 and/or 13485) and injection molding technologies would be an advantage.  

What You'll Do  

• Representing and enforcing DFM/A in design reviews and DFMEAs. 

• Leading PFMEA / Control Plan creation and updates (with supplier participation).  

• Creation of assembly flow charts or supervision of supplier assembly flow charts creation for manufacturing or rework activities.  

• Creation of Work Instructions or supervision of supplier Work Instruction creation for manufacturing or rework activities.  

• Creation of Control Plans or supervision of supplier Control Plan creation for manufacturing or rework activities.  

• Support the mechanical and industrial design process and lead the transition to manufacturing. 

• 3D CAD design experience with advanced surface modelling 

• Liaise with the in-house and external manufacturing teams and CMs. 

• Lead low-volume prototype assembly activities and device testing procedures. 

• Identification of DFM/A improvements to existing products to include a cost-benefit analysis to allow senior evaluation and approval.  

• Identification of manufacturing process improvements to existing processes at CM and tiered supplier base to include a cost-benefit analysis to allow senior evaluation and approval.  

• Supporting the qualification and selection of new suppliers by providing a thorough evaluation of the suppliers’ manufacturing capabilities.  

• Create Engineering Change Notices (ECN) as related to manufacturing process improvements.  

• Contribute documentation to the Quality Management System to support ISO 13485 requirements. 

Who You Are  

• Bachelor's degree in mechanical engineering.  

• Minimum of 5 years' experience as a manufacturing design engineer in a high-volume manufacturing environment.  

• Expertise in DFM/A and Lean Manufacturing techniques.  

• Experience of participation in a product development team from inception to manufacturing launch including evidence of the imposition of DFM/A into the design.  

• Knowledge of the requirements of TS16949 and ISO9000.  

• Knowledge and execution experience of APQP, PPAP, PFMEA, Control Plans, and Process Flow.  

• Strong working knowledge of SolidWorks CAD software. 

• Proven verbal and written communication skills.