Senior Mechanical Testing Engineer

SHL Group; Zug; Hybrid; CHF 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Flexible hours

Hybrid working policy

Zusammenfassung

SHL Medical is seeking a Senior Testing Engineer to manage and execute testing activities during product development, identify suitable test equipment, and develop test fixtures and methods for drug delivery systems.

The role includes establishing a modern testing lab and coordinating with global Testing and Simulation teams, ensuring design control and risk mitigation through data-driven verification.

Qualifikationen

• Master or PhD in Biomedical Engineering, Electrical or Mechanical Engineering, Chemical Engineering or in a related field.
• Minimum of 5 years of experience in similar role for medical products or equivalent.
• Good knowledge in planning qualification, verification, and validation phases.
• Good knowledge in industrial measurement technology (force, torque, optical, multisensory, CT X-Ray).
• Good knowledge in statistical data analysis with tools such as Minitab.
• Experience in writing test protocols/reports and quality records.
• Experience with regulatory and quality standards.
• Fluent in English written and spoken.

Aufgaben

• Provide expertise in Combination Products and drug delivery systems performance testing for assigned projects.
• Plan, design and execute/coordinate design characterization, design assessment and design verification of injection systems.
• Develop and validate functional, mechanical, analytical and optical test methods.
• Analyze test results, including statistical evaluation and reporting.
• Produce design control and risk mitigation documents.
• Support investigations of customer complaints.
• Build up a new testing lab in Zug, CH.
• Lead external testing labs and select partners.
• Support Center of Competences and cross- functional collaboration.

Kenntnisse

Test planning

Design verification

Statistical analysis

Communication

Ausbildung

Master's or PhD in Biomedical Engineering / Electrical / Mechanical / Chemical Engineering

Tools

Minitab

Test equipment design tools

Jobbeschreibung

About the company

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

The position ofSeniorTesting Engineeris responsible of managing andexecutingtesting tasks during product development processbyidentifyingand defining the right test equipment to use, developing testfixtures and methods upon the chosen equipment, anddefining and executingdesign characterization, assessment, and verificationactivities.Further, the Senior Testing Engineercontributes to the establishment of a modern testing lab and/or testing network and thecenter of excellenceswithin the global Testing and Simulation organizationin the field of drug delivery systems.The position ofSeniorTesting Engineer reports to theHead of Testing CH.

Main Responsibilities

• Provide expertise in the field of Combination Products and drug delivery systems performance testing to contribute to the assigned projects/duties
• Plan, design and execute/coordinate design characterization, design assessment and design verification of injection systems based on design input requirements and risk assessments
• Develop and validate functional, mechanical, analytical and optical test methods
• Analysis of test results, including statistical evaluation and compilation of results into reports
• Produce corresponding design control and risk mitigation documents
• Support in investigations of customer complaints
• Building up a new and operational testing lab (in Zug, CH)
• Participate actively in the selection of the external labs and lead these external testing labs
• Support and establish Center of Competences of part of the global Testing and Simulation Organization vision
• Support PLM and QM (Risk Mitigation) with performance requirements/evidence rest on (test/simulation) data
• Ensure strong alignment and a supportive collaboration on method industrialization activities with quality teams and other functions in a global environment
• Pro-active communication of results and knowledge with internal and external stakeholders

Minimum Requirements

• University of engineering or life science: Master or PhD in Biomedical Engineering, Electrical or Mechanical Engineering, Chemical Engineering or in a related field
• Minimum of 5 years of experience in similar role for medical products and/or equivalent experience in a relevant academic environment (strong scientific background in all aspects of Combination Products and drug delivery)
• Good knowledge in planning qualification, verification, and validation phases
• Good knowledge in industrial measurement technology (force, torque, optical, multisensory, CT X-Ray)
• Good knowledge in statistical data analysis with tools such as Minitab
• Experience in writing test protocols/reports and quality records
• Experience with regulatory and quality standards
• Fluent in English written and spoken

Preferred Requirements

• 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%)
• German and/or Mandarin knowledge/fluency

We Offer

• A company culture Focusing on our Customers, Operating with Ethics and Integrity, Driving Simplicity, Learning, Improving & Delivering Together.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast growing and innovative industry.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.
• Centrally located office in Zug, very close to the train station.

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.

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

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