Senior Drug Delivery Systems Engineer — Flexible Hours

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

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.