R&D Engineer 3/ Sustaining Engineering Trauma/CMF

Solothurn

R&D Engineer 3/ Sustaining Engineering Trauma/CMF

For our client in Zuchwil we are looking for an R&D Engineer 3/ Sustaining Engineering Trauma/CMF for a 8-month contract.

Job title: R&D Engineer 3/ Sustaining Engineering Trauma/CMF

Duration: 01/05/2019 to 31/12/2019 (extension possible)

Location: Zuchwil 

Workload: 100%

Description:
The candidate will be responsible for global Design & Technical Documentation of Trauma/CMF implants and instruments following European (MDD/MDR), US (510k) and other regulations. 
The position is focused on Lifecycle management more than new prodict development. 

Position Duties and Responsibilities: 
• Designs and develops new implants and instruments and develops improvements and modifications to current products according to the DePuySynthes product development process 
• Responsible for the product design 
• Is primary contact person for technical questions/issues of existing products 
• Participates or leads development and/or product improvement projects 
• Interacts within cross-functional teams and supply chain and participates or leads process & product improvements 
• Works with surgeons, sales force and others for design requirements, design concept 
development, prototype and cadaver evaluation, and clinical follow-up 
• Responsible for initial patent review of designs for freedom to operate as well as for the protection of new concepts, techniques and products through proper patenting 
• In close collaboration with the technical engineering office, generates product models, concept layouts, and prints using CAD software ProE/CREO. 
• Responsible for the performance of the product and its mechanical stability, as well as the application of geometric dimensioning and tolerancing (GD&T) 
• Develops mechanical test set-ups (including derivation of benchmarks) according to national and international standards and coordinates the activities required to fabricate test parts and Plan/execute mechanical testing in collaboration with Swiss and US test labs. 
• Works with manufacturing during the design stages to incorporate manufacturability into the product designs and during the implementation phase to clarify design issues 
• Performs the required activities and generates the appropriate technical documents to ensure compliance with national and international regulations related to medical devices (in particular EU MDD, EU MDR, US FDA, Japanese PAL) 
• Responsible for implementing of new MDR requirements/documentation across Trauma/CMF products. Strong collaboration and interaction with Supply Chain – in EU as well as in US. 
• Supports surgeons with regards to handling of implants/instruments and engineering-specific questions 
• Performs other special projects and functions as assigned 
• Know and follow all laws and policies that apply to the job, and to maintain the highest levels of professionalism, ethics and compliance at all times 

Must haves: 
• A minimum of BS in a related scientific or engineering field. 
• A minimum of 3 years of experience in product development and/or life-cycle-management of medical devices. 
• Experience with documentation and Technical Files according to EU MDD and CFDA, MDR precognition preferred. 
• Manufacturing background or profound manufacturing process know-how, experience in manufacturing of medical devices preferred. 
• Good mechanical engineering skills combined with problem-solving and project management abilities. 
• Profound knowledge of applicable European (EN), US (ASTM, etc.) and international (ISO, etc.) standards for medical devices 
• Excellent communication and interaction skills. 

• German: Basic knowledge preferred
• English: Business fluent 

Soft skills:

- Some flexibility in working hours is required (May require up to 10% travel)

- Must be able to work on multiple simultaneous tasks with limited supervision;

- Quick learner, motivated self-starter;

- Excellent customer service, interpersonal, communication and team collaboration skills;

- Able to follow change management for internal guidelines

For further details please contact:
Anna Siemienkiewicz
Anna.Siemienkiewicz@HarveyNash.com
+41435081497

Solothurn
Negotiable
  1. Contract

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