Drug Delivery Systems Engineer (m/f/d, fix-term 100%)

Congenius AG; Bern; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Congenius AG in the Bern area seeks a senior engineer to lead development and documentation for combination products and drug delivery devices, covering respiratory, subcutaneous, and intravenous delivery.

You will plan, coordinate, and manage projects, develop design controls and risk management documents, and ensure timely, compliant delivery of innovative medical devices and manufacturing processes while collaborating with R&D, Quality, and Operations.

Qualifikationen

• Master or PhD in Biomedical, Electrical, or Mechanical Engineering.
• 5+ years in the pharmaceutical or medical device industry with knowledge of combination products and drug delivery systems.
• Experience with design controls, risk management, and quality documentation for regulated products.
• Strong analytical and problem-solving skills with a structured, hands-on style.
• Ability to work independently and collaborate in cross-functional and international teams.
• Fluency in English; German is an advantage.

Aufgaben

• Lead development and documentation activities for combination products and drug delivery devices for respiratory, subcutaneous, and intravenous delivery.
• Plan, coordinate, and manage project activities to ensure timely execution of work packages.
• Develop and maintain design control and risk management documentation to meet requirements and standards.
• Deliver portfolio projects within timelines, quality standards, and budget constraints; drive innovations in devices and processes.
• Improve design and development processes, including tech transfer, qualification, and optimization efforts.
• Collaborate with R&D, Quality, and Operations to align strategies and ensure seamless handover of projects.

Kenntnisse

Design controls

Risk management

Quality documentation

Analytical skills

Independent work

Cross-functional collaboration

Ausbildung

Master's in Biomedical Eng

PhD in Biomedical Eng

Jobbeschreibung

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 constrains, 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, customization, specification, introduction, integration, qualification, optimization 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. Supporting business, technical and project questions with data, information, suggestions and professional assessment

Your Skills and Experience

• Master or PhD in Biomedical, Electrical, or Mechanical Engineering or in a related discipline
• Minimum 5 years of 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.
• Fluent in English is a must, German is an advantage
• You will work in the Bern area for an ambitious, international pharmaceutical company in the medical technology sector with a very good working atmosphere
• You benefit from flexible working hours and an exciting and versatile field of activity
• You work in a company with a flat hierarchy, short decision‑making processes
• You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• You benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer

Who we are

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.