Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead the technical development of combination products and medical devices from concept through commercialization
• Define and assess primary packaging solutions, applying expertise in Type I glass, COP/COC polymers, elastomers, coatings, and extractables & leachables (E&L)
• Develop container closure and device integration solutions that ensure container integrity, manufacturability, and reliable product performance
• Provide technical oversight and guidance to external development partners
• Lead complex root cause investigations and resolve device and packaging-related challenges using structured problem-solving methodologies
• Author design control, risk management, verification, and regulatory documentation
• Support regulatory submissions and health authority interactions
• Ensure compliance with applicable regulations and standards, including ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 4, ISO 11040, ISO 11608, USP 1207, USP 381, and USP 660

Your Skills & Experience

• Bachelor’s or Master’s degree in Engineering or a related technical discipline
• 5+ years’ experience in medical device, combination product, or drug delivery device development within a highly regulated environment (cGxP/QSR)
• Strong expertise in container closure systems, particularly prefilled syringes and cartridges for parenteral drug delivery
• Experience with fill-finish processes, including stoppering technologies
• Solid understanding of materials science, elastomers, coatings, defect mechanisms, and performance testing
• Proven technical leadership and strong problem-solving capabilities in cross-functional projects
• Deep knowledge of the regulatory framework and industry standards governing combination products and medical devices
• Experience supporting regulatory submissions, including technical authoring for IND/IMPD and NDA/BLA filings
• Proficiency in risk management, reliability engineering, tolerance analysis, statistical methods, and process capability assessments
• Excellent communication, documentation, and stakeholder management skills
• Fluency in English is a must, German is an advantage

Benefits

• Work in the Basel area for an international pharmaceutical company in the combination product sector
• Benefit from flexible working hours in an exciting and versatile field of activity
• Expect a pleasant working atmosphere, with uncomplicated and collegial cooperation, at a company with a flat hierachy and short decision-making processes
• Take advantage of modern and attractive working conditions and development opportunities
• Receive an attractive salary and excellent social benefits

To apply for this role, see our LinkedIn jobs page.

Reporting into our Head of Quality, Dr. Dirk Hüber

Your Responsibilities

• Lead technical development and documentation activities related to combination products and drug delivery devices for respiratory, subcutaneous, and intravenous delivery
• Independently plan, coordinate, and manage project activities, ensuring timely execution and delivery of assigned work packages
• Develop and maintain design control and risk management documentation in compliance with applicable requirements and standards
• Execute portfolio projects within the agreed timelines, quality standards and budget constraints, delivering innovative, competitive, and state-of-the-art medical devices, combination products, and associated manufacturing processes
• Actively contribute to improvement of combination product design, development, customisation, specification, introduction, integration, qualification, optimisation and technology transfer processes and procedures
• Collaborate effectively with partners in R&D, Technical Operations, Quality, and Operations in developing aligned strategies and concepts for the development of combination products and ensuring seamless handover of projects and aligned development of technologies and knowledge
• Maintain knowledge of relevant legislation, regulation, guidance, normative requirements and industry trends in the field of combination products
• Maintain own specialist expertise through exposure, education, training, application
• Support business, technical, and project questions with data, information, suggestions, and professional assessment

Your Skills & Experience

• Master’s or PhD in Biomedical, Electrical, or Mechanical Engineering or in a related discipline
• Minimum 5 years’ experience in the pharmaceutical or medical device industry, with strong knowledge of combination product and drug delivery systems
• Experience with design controls, risk management, and quality documentation for regulated products
• Strong analytical and problem-solving skills, combined with a structured and hands-on working style
• Proven ability to work independently and collaborate effectively within cross-functional and international teams.
• Fluency in English is a must, German is an advantage

Benefits

• Work in the Bern area for an ambitious, international pharmaceutical company in the MedTech sector
• Benefit from flexible working hours in an exciting and versatile field of activity
• Expect a pleasant working atmosphere, with uncomplicated and collegial cooperation, at a company with a flat hierachy and short decision-making processes
• Take advantage of modern and attractive working conditions and development opportunities
• Receive an attractive salary and excellent social benefits

To apply for this role, see our LinkedIn jobs page.