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Innovative mechanical engineering solutions lead

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beBeeMechanical
Inserat online seit: 15 Juli
Beschreibung

Senior Design Engineer Role

This is a challenging opportunity for an experienced mechanical engineer to lead the design of our cutting-edge autoinjector product platform.

* The role involves sustaining engineering, driving continuous improvement initiatives, and ensuring our products remain reliable, compliant, and competitive in ever-evolving markets.

Main Responsibilities:

1. Developing device architecture refinement, engineering requirement establishment, 3D/2D modeling, Design for Functionality/Manufacturability/Sustainability/Cost, performance analysis and risk-based design assessment planning.
2. Providing technical leadership for the design of platform development projects.
3. Documenting and communicating results through authorship of technical memos, reports and presentations.
4. Evaluating market and further stakeholder feedback and identifying and mitigating risks and improvement possibilities associated with device functionality, reliability, safety, cost, sustainability and manufacturing scalability.
5. Leading strategy and execution of feasibility and engineering confidence tests to determine new device design viability and robustness, alongside with computation modelling and simulation.
6. Ensuring all activities comply with global regulatory requirements (FDA, CE, etc.) and relevant industry standards (e.g., ISO 13485).
7. Overseeing platform updates and changes through rigorous change control processes, conducting risk assessments and necessary verifications/validations.
8. Maintaining visibility as a sought-out internal subject matter expert and taking the lead in interaction with global stakeholders to find rational and consensus-driven design solutions.

Requirements:

* A Master's degree in mechanical engineering, biomedical engineering, or other similar discipline.
* A minimum of 5 years' experience as a Senior Design Engineer for injection molding-based products in the medical industry or strongly regulated industry.
* Excellent skills in CAD (Solidworks), simulation software, and statistical analysis.
* Experience in design toolkits/methodologies, such as 3D/2D modeling, Tolerance Analysis, Simulation (FEA) Analysis, Modulation design, Risk Analysis tools (FMEA, FTA), and Innovation methods (ex: TRIZ).
* Expertise with regulatory requirements for combination products (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366).
* A strong DFx experience (Design for Testing, Manufacturing, Assembly, Quality, Cost, Sustainability) and willingness to drive the design for optimum solutions in consideration of all stakeholder needs.

We Offer:

* Challenging assignments in a fast-growing and innovative industry.
* A multicultural team and modern working environment with state-of-the-art facilities and technologies.
* A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
* Various opportunities for personal and professional development within a global organization.
* Flexible hours and hybrid working policy.

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