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

The Sr. Quality Engineer - Design & Development is responsible for the effectiveness and quality of product design and process developments and ensuring compliance with applicable medical device regulations and cGMP standards. Quality Engineer supports risk management activities, ensures that products are of high quality and directs product development decisions by promoting a Risk-Based approach. Applies Quality Engineering tools, techniques, and methodologies to product development according to the company’s needs and applicable regulations. The job holder is directly involved in establishing and applying efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.

Main Responsibilities

• Represent Quality Engineering in all Design Controls and Product Development related aspects
• Ensure the efficiency of Design Controls (Quality by Design) in product development and product maintenance activities
• Ensure compliance with relevant medical device and cGMP standards and regulations
• Actively take part in and facilitate Product Development and Quality process improvement efforts
• Apply Quality Engineering principles and tools in a dynamic way to development projects
• Utilize Quality Engineering best practices, ensuring internal and external customers’ needs and requirements are built into new products and future product changes
• Team member in digitalization programs related to QMS and product lifecycle management (PLM)
• Support Risk Management activities and directs product development decisions by promoting a Risk-Based approach
• Collaborate with Subject Matter Experts to identify and trace critical-to-quality attributes (CTQs) through all product development phases and to establish the control strategy
• Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction.
• Promote Advanced Product Quality Planning (APQP) and Design For Six Sigma (DFSS)
• Ensure all functions adhere to SHL procedure’s requirements and standards during all development and manufacturing stages.

Minimum Requirements

• Minimum 5 years of experience in product development from concept to launch within the Medical Device or Pharmaceutical industry
• Expert knowledge of Design Controls and Product Development processes, particularly for medical devices and/or combination products.
• Knowledge of ISO 13485, QSR 820, SIO 14971, IEC62366, IEC62304
• Experience in establishing processes, authoring procedures, and driving cross-functional collaboration
• Excellent communication and stakeholder management skills with a strong customer-oriented approach.
• Consensus-building abilities to negotiate project deliverables, risks, and priorities.
• Team player and self-starter capable of thriving in an international, cross-company environment.
• Solution-oriented mindset coupled with solid analytical and decision-making skills.
• Willingness to travel internationally (up to 10%).
• Language: Fluent in English

Preferred Qualifications

• Experience with combination products
• University degree in an engineering, life science or related scientific discipline
• Training and practical application of quality engineering methodologies (e.g. APQP, Lean, Design for Six Sigma)
• Working knowledge of statistical analysis and related software.
• Language: Fluent in German  

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.