Senior Mechanical Testing Engineer

SHL Medical; Zug; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Hybrid working policy

Office near Zug train station

Zusammenfassung

SHL Medical in Zug, CH seeks a Senior Testing Engineer to lead and execute testing activities during product development for advanced autoinjectors and related systems. You will select test equipment, develop fixtures, and drive design characterization, verification, and validation in a growing testing network.

You will build a modern lab, collaborate across PLM and QM, and lead external labs while ensuring quality and regulatory alignment for drug delivery technologies.

Qualifikationen

• Master or PhD in Biomedical, Electrical, Mechanical, Chemical Engineering or related field.
• Minimum 5 years in similar role for medical products or related academic environment.
• Fluent in English (written and spoken).

Aufgaben

• Plan, design and execute design characterization, design assessment and design verification of injection systems.
• Develop and validate functional, mechanical, analytical and optical test methods.
• Analyze test results with statistical evaluation and compile reports.
• Build and operate testing lab networks and coordinate external labs.
• Support quality and risk mitigation with test data and design controls.

Kenntnisse

statistical data analysis

problem solving

cross-functional collaboration

Ausbildung

Master or PhD in Biomedical Engineering

Tools

Minitab

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 of Senior Testing Engineer is responsible of managing and executing testing tasks during product development process by identifying and defining the right test equipment to use, developing test fixtures and methods upon the chosen equipment, and defining and executing design characterization, assessment, and verification activities. Further, the Senior Testing Engineer contributes to the establishment 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.

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.

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

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