Job Description

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

We are currently searching for a Junior Manufacturing Engineer (f/m/x)

Reporting to the R&D and QE Workstream site-lead Aarau for MDR, the role has the responsibility of working in the R&D/QE MDR Workstream to plan and execute R&D/QE activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain quality standards, comply with regulatory and compliance standards. Job responsibilities include addressing well defined problems of limited scope and following standard practices and procedures.

This workstream is responsible for ensuring all product related documentation submitted as part of a technical file is remediated to standards required by the MDR legislation. In addition new processes must be established for NPD projects to ensure future MDR compliance – including those within the current project pipeline and future project initiation.

What will you be doing?

• Identify and resolve complex technical and operational challenges related to the R&D/QE Workstream for Orthopedics
• Working with other stakeholders in Aarau to contribute to overall decision making, cross functional thinking and to progress the overall project
• Define and implement procedures and templates within the R&D/QE environment by keeping products compliant with legislation and allowing products to be maintained in the market place
• Update of all R&D/Quality documentation (e.g. Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings (6-8 activities which are important for the function)
• Ensure that all product testing data (e.g. Life-Cycle, MRI, biocompatibility) is remediated or developed to MDR standards
• Update existing R&D/Quality processes for maintenance/creation of design history files and other supporting documentation
• Establish new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under the MDR legislation
• Assess design relatated risks
• Prepares design drawings and acts as a consultant in the preparation of final or modified drawings in line with MDR requirements
• Support and advise other team-members in the R&D/QE Workstream enabling them to work efficient and autonomous
• Support elicitation and procurement of new manufacturing equipment
• Identify and drive continuous improvement initiatives, including cost reduction opportunities

Quality and Health & Safety (HSE) responsibilities:

• Knows and adheres to the quality policy of the company and the quality-related procedures and instructions
• Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department
• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)
• Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department
• Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function
• Completes all required HSE training

What will you need to be successful?

• Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field
• Ability to work effectively in a cross-functional team environment
• CAD (NX)
• High learning agility
• Strong written and verbal communication and technical writing skills (German and English)
• Analytical approach to problem solving
• Must have strong documentation skills with attention to detail.
• 3-5 years’ experience in Medical devices with project management experience

You. Unlimited.
We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.
Inclusion and Belonging:Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learnmore about our Employee Inclusion Groupson our website (www.smith-nephew.com)