Lead, Drug–Device Engineering & Strategy

CSL Plasma Inc.; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Restaurant perks

Zusammenfassung

CSL Behring is seeking an Associate Director of Device Engineering in its DDSP organization. The role leads the device engineering team, driving drug–device combination product development, risk management, and program-level integration with CMC and product strategy.

The ideal candidate has 10+ years in pharma/med device, strong leadership, and excellent communication within a matrix environment. International travel up to 20% is expected.

Qualifikationen

• At least 10 years of related experience in the pharmaceutical or medical device industry.
• Subject Matter Expertise on medical device development with a preference for drug-device combination product development and sustaining.
• Excellent communication skills and a track record working in a matrix environment.
• The role requires an ability to travel internationally up to 20%.

Aufgaben

• Lead the Device Engineering team for drug–device combination product development across assets, coordinating inputs from multiple functions.
• Mentor team members and coordinate device development activities including inputs, outputs, verification/validation planning, supplier qualification, and regulatory submission support.
• Own and maintain the Design History File (DHF) and ensure documentation is complete, inspection-ready, and compliant with CSL quality system and regulatory frameworks.
• Translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables.
• Lead risk management activities and plan/implement combination product control strategies across supply.
• Represent device engineering on cross-functional program teams and ensure deliverables align with program needs.

Kenntnisse

Cross-functional leadership

Risk management

Program management

Ausbildung

Science or Engineering degree

Jobbeschreibung

CSL Behring is seeking an Associate Director of Device Engineering in its DDSP organization. The role leads the device engineering team, driving drug–device combination product development, risk management, and program-level integration with CMC and product strategy.

The ideal candidate has 10+ years in pharma/med device, strong leadership, and excellent communication within a matrix environment. International travel up to 20% is expected.