About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

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. 

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.