Senior Design Engineer - Product Platforms(m/w/x)

Job Description Senior Design Engineer - Product Platforms Job Location: Zug **Job Overview** Leading the design aspects of one of our cutting-edge autoinjector product platforms. Your role will encompass sustaining engineering, driving continuous improvement initiatives, and ensuring our products remain reliable, compliant, and competitive in ever-evolving markets. **Main Responsibilities** 1. Platform Mechanical Design and Engineering Excellence * Plan, design and execution of device design tasks for one of SHL’s platforms including device architecture refinement, engineering requirement establishment, 3D/2D modeling, Design for Functionality/Manufacturability/Sustainability/Cost, performance analysis and risk-based design assessment planning, etc., to fulfill all product requirements * Provide technical leadership for the design of platform development projects * Thoroughly document and communicate results through authorship of technical memos, reports and presentations. 2. Sustaining Engineering & Continuous Improvement * Evaluate market and further stakeholder feedback and identify and mitigate risks and improvement possibilities associated with device functionality, reliability, safety, cost, sustainability and manufacturing scalability. * Technically lead the device technology and patent landscaping evaluations and provide accordingly design recommendations and design revision plans * Lead strategy and execution of feasibility and engineering confidence tests to determine new device design viability and robustness, alongside with computation modelling and simulation. 3. Quality & Regulatory Compliance * Ensure all activities comply with global regulatory requirements (FDA, CE, etc.) and relevant industry standards (e.g., ISO 13485). * Oversee platform updates and changes through rigorous change control processes, conducting risk assessments and necessary verifications/validations. * Master NCMRs from production and support root cause analysis beyond the design scope of the platform 4. Global Team Collaboration * Strong engagement with SHL’s Subject Matter Experts for Human Factors, Regulatory, Engineering & Manufacturing, Testing, Quality Engineering Quality & Regulatory Compliance * Maintain visibility as a sought-out internal subject matter expert and take the lead in interaction with global stakeholders to find rational and consensus driven design solutions * Collaborate with the customer design solution teams and strive for an optimum platform design and documentation to serve customer project execution excellence **Minimum Qualifications** * Master’s degree in mechanical engineering, biomedical engineering, or other similar discipline * Senior Design Engineer for injection molding-based products with 5+ years’ relevant experience in 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). * 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 * Strong communication skill and the ability to condense complex information in its essentials to support strategic decisions * Out-of the box thinker, strong strategic mindset and requirements driven design implementation * Strong willingness to evaluate, apply and champion modern tools and methods for design excellence such as Six Sigma and Systems Engineering concepts * First principles advocate: Proven track record of breaking down complex problems into a first principles analysis * Experience of supporting multiple projects of varying complexity simultaneously. * Experienced to lead a team of designers to realize complex design solutions * Open-minded, initiative, constructive & positive thinking, persistent, results-oriented, and able to work under pressure in changing environments * Fluency in English **Preferred Qualifications** * Expertise of regulatory requirements for needle-based injection systems (ISO 11608-1) * Experience in designing and development of medical device from early concept to launch phases, preferably in the drug delivery space * Proven track record to apply platform design and systems engineering concepts into medical device mechanical design * Ability to solve challenging problems and cultivating a continuous improvement culture that manifests into the platform design * A keen eye for identifying design risks and proactively developing mitigation plans **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.