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SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
Overview
The position of Senior Testing Engineer will be managing the development of strategies for applying platform approaches for combination product development (considering worst-case testing, rationales, HIC, etc), as well as in the establishment of right processes for verification /submission strategies to build an effective legal manufacturer organization. Further, the Senior Testing Engineer will contribute to the setting up of a modern testing lab and/or testing network and the center of excellences within the global Testing and Simulation organization in the field of drug delivery systems. The position of Senior Testing Engineer reports to the Head of Testing CH.
Responsibilities:
- Provide expertise in the field of Combination Products and drug delivery systems performance testing to contribute to the assigned projects/duties
- Design and implement test strategies and methodologies to demonstrate that devices within specified design envelopes meet the established design inputs, considering worst cases, identified risks and the outcomes of risk assessment
- Support PLM and QM (Risk Mitigation) with performance requirements/evidence based on (test/simulation) data that can be leveraged for subsequent programs
- Support the setup of a quality management system (QMS) for verification /submission strategies to build an effective legal manufacturer organization for medical (electromechanical) devices
- Plan, design and execute/coordinate design characterization, design assessment and design verification of injection systems based on design input requirements and risk assessments
- Analysis of test results, including statistical evaluation and compilation of results into reports
- Produce corresponding design control and risk mitigation documents
- Building up a new and operational testing lab (in Zug, CH)
- Support and establish Center of Competences of part of the global Testing and Simulation Organization vision
- Develop and validate functional, mechanical, analytical and optical test methods
- Participate actively in the selection of the external labs and lead these external testing labs
- Ensure strong alignment and a supportive collaboration on method industrialization activities with quality teams and other functions in a global environment
- Support in investigations of customer complaints
- Pro-active communication of results and knowledge, timelines and readiness with internal and external stakeholders
Minimum Requirements:
- University of engineering or life science: Master or PhD in Biomedical, Mechanical, Materials or Electrical Engineering, or in a related field; or Bachelor with 10 or more years of relevant experience
- Minimum of 5 years of experience in similar role for medical products.
- Good knowledge in design verification, platform strategies and submissions
- Experience with regulatory and quality standards (e.g., FDA QSR, ISO 13485, IEC 60601).
- Good knowledge in statistical data analysis with tools such as Minitab
- Experience in writing test plans/protocols/reports and quality records
Preferred Requirements:
- Good knowledge in industrial measurement technology (force, torque, optical, multisensory, CT X-Ray, electro-mechanical systems)
- Ability to analyze technical problems and systematically develop detailed solutions
- Ability to work effectively with other departments in cross-functional projects and maintain effective communication with internal and external stakeholders.
- Open-minded, proactive, persistent, results- and execution-oriented, and able to work under pressure in changing environments
- Team player and self-starter, able to perform with minimal supervision
- Ability to travel internationally (up to 10%)
What we offer:
- An exciting opportunity in a fast-growing international medical device company
- A working environment with multicultural and dynamic teams
- Multisite office options in Zug, close to the train station (1 to 10 min distance)
- Position in a dynamic, international team of highly skilled professionals
- Flexible working hours and possibility of some remote work
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department. Apply now!
Please note: We do not accept applications from Recruitment agencies for this position.
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