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<p><span style="font-size: 24pt; color: #3598db;">Research & Development Medical Device Engineer (m/f/d)</span></p> <p>Working directly with the experienced Device R&D Managers, you will be an intrinsic part of the development team, helping to develop and shape the new generation of combination products for the US and EU territories. Taking direction from experienced engineers, you will be responsible for key deliverables including writing specifications, protocols and more importantly liaising with external partners and suppliers to influence fundamental device and product design & manufacturing decisions. This is your perfect opportunity to join a small dynamic team, whilst having the security, resources and stability provided by the Tiefenbacher Group.</p>
A challenging task
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<ul style="list-style-type: square;"> <li>Working on the development, integration & commercialisation of the device constituent part(s) of combination products / medicinal products under FDA and EMA regulations.</li> <li>Working alongside other engineers both internal and external to drive forward and solve complex engineering issues aligning to the overall product objectives.</li> <li>Developing and optimising product designs and industrial processes from inception through to transfer for manufacturing.</li> <li>Author and aid in the execution of equipment qualification procedures.</li> <li>Ensure the impact of design and process changes are fully assessed and necessary revisions to the technical file are made using appropriate change control procedures.</li> <li>Conduct risk management in compliance to ISO 14971, including the application of FMEA’s, FTA, Threshold Analysis and URRA preparation.</li> <li>Provide clear documentation to support design and process changes.</li> <li>Supporting external product development teams in the USA and Europe. </li> <li>Identify process problems and non-conformance’s in manufacturing processes and support the development of corrective actions.</li> <li>Support internal audits and work under ISO 13485.</li> <li>Developing individual solutions for the various product development processes in cooperation with both external partners and internal departments.</li> <li>Manage and execute Verification & Validation activities associated with design or process changes directly and via partners.</li> <li>Organise, execute and follow up on design reviews for the device and or device-constituent part of a combination product.</li> </ul>
A convincing background
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<ul style="list-style-type: square;"> <li>Successfully completed studies in Product Design, Electro-Mechanical, Mechanical Engineering or several years of established Medical Device / Combination Product or associated industrial experience.</li> <li>Experience or understanding of standards including: <ul style="list-style-type: square;"> <li>ISO 13485, ISO 20072, ISO 14971, ISO 62366</li> <li>21 CFR part 820, 21 CFR part 830</li> </ul> </li> <li>Understanding to advance complex projects and communicate openly and purposefully with internal and external teams</li> <li>Strengths to include the ability to analyse complex mechanisms, communicate your understanding to technical staff outside of your discipline, and utilise persuasive dialogue to further development.</li> <li>Experience in usability requirements and assisting in performing human factor studies for various intended patient populations</li> <li>Highest expectations of your work and pro-actively engage in multidisciplinary project teams</li> <li>Working knowledge covering the following areas would be advantageous: <ul style="list-style-type: square;"> <li>Injection moulding an advantage (an understanding of)</li> <li>Tolerance analyses</li> <li>Assembly Equipment Design & Validation</li> <li>Metrology</li> <li>An understanding of process validation, process control and statistics</li> <li>Product Validation and Verification</li> <li>Risk Management</li> <li>Use Related Risk Analyses</li> <li>Specification writing</li> </ul> </li> <li>Willingness to adapt and learn. </li> <li>Excellent communication in English</li> </ul>
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<p>You are interested in our company and the position we can offer you?</p> <p>Then apply online via the <em>Apply for this Job</em> button, we will be pleased to receive your application.</p> <p>The position will be filled by our HR Business Partner <span style="color: #3598db;">Marie-Theres Blumers</span>.</p> <p><img src="https://tiefenbacher-group-jobs.powerappsportals.com/Bild_MBL.jpg" alt="" width="380" height="263" /></p> <p>We look forward to hearing from you!</p>
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