Sr Quality Engineer (Product Design & Development)

SHL Medical AG seeks a Senior Quality Engineer in Zug to lead quality aspects of medical device design, ensuring regulatory compliance and driving risk-based development processes.

The company is looking for a senior professional to oversee the quality and effectiveness of product design and process development. This role ensures that all activities comply with medical device regulations and cGMP standards while promoting a risk-based approach to guide development decisions. The engineer will establish efficient design controls and collaborate across departments to integrate quality into every stage of the product lifecycle.

Responsibilities

• Act as the primary Quality Engineering representative for all design control and product development initiatives.
• Guarantee the efficiency of Quality by Design principles throughout product development, process creation, and maintenance phases.
• Maintain strict adherence to relevant medical device regulations and current Good Manufacturing Practice (cGMP) standards.
• Lead and facilitate continuous improvement efforts within product development and quality processes.
• Apply quality engineering tools dynamically to support development projects.
• Integrate internal and external customer requirements into new products and future modifications using best practices.
• Participate in digitalization programs focused on Quality Management Systems (QMS) and Product Lifecycle Management (PLM).
• Support risk management activities and guide product development choices by advocating for a risk-based methodology.
• Work with subject matter experts to identify and trace critical-to-quality attributes across all development phases and define control strategies.
• Evaluate simulations, designs, manufacturing processes, and engineering experiments (DOEs) to inform product and process direction.
• Promote the adoption of Advanced Product Quality Planning (APQP) and Design for Six Sigma (DFSS) methodologies.
• Ensure all functions follow SHL Medical’s procedures and standards during development and manufacturing.

Requirements

• At least five years of hands-on experience in product development, from concept to launch, within the medical device or pharmaceutical sectors.
• Deep expertise in design controls and product development processes, specifically for medical devices or combination products.
• Familiarity with ISO 13485, QSR 820, ISO 14971, IEC62366, and IEC62304 standards.
• Proven ability to establish processes, write procedures, and drive cross-functional collaboration.
• Strong communication and stakeholder management skills with a customer-focused mindset.
• Ability to build consensus when negotiating project deliverables, risks, and priorities.
• Self-motivated team player who thrives in international, cross-company environments.
• Solution-oriented mindset with solid analytical and decision-making capabilities.
• Willingness to travel internationally up to 5% of the time.
• Fluent proficiency in written and spoken English.

Nice to have

• Fluent proficiency in written and spoken German.
• Bachelor’s degree in engineering, life sciences, or a related scientific field.
• Training and practical experience with quality engineering methodologies such as APQP, DMAIC, Lean, or Design for Six Sigma.
• Working knowledge of statistical analysis and associated software tools.

What the company offers

• Challenging assignments within a fast-growing and innovative industry.
• An exciting opportunity to join a rapidly expanding international medical technology company.
• A modern working environment characterized by multicultural and dynamic teams.
• A centrally located office in Zug, situated very close to the train station.

About the company

SHL Medical AG is a fast-growing international medical technology company known for its multicultural and dynamic teams. The organization operates in an innovative sector, offering a modern work environment that encourages collaboration across diverse backgrounds.

• Fast-growing international medical technology company.
• Multicultural and dynamic teams.