Senior Sales Representative (m/w/d) Schweiz

Fisher Investments; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL in Switzerland seeks an Associate Director of Device Engineering to lead the Device Engineering team for drug–device product development across assets. You will coordinate cross-functional inputs from Device Engineering, Quality, Regulatory, and Manufacturing to drive design, verification, and regulatory readiness, while maintaining the DHF and compliance with CSL quality systems.

The role requires a proven track record in medical device development, strong leadership, and ability to travel

Qualifikationen

• A relevant Science or Engineering degree is required.
• At least 10 years of experience in pharmaceutical/medical device industry.
• Strong leadership and matrix collaboration skills.
• Excellent communication and travel up to 20%.
• Ability to lead end-to-end development of drug-device combinations.

Aufgaben

• Lead the Device Engineering team for drug–device product development across assets, coordinating cross-functional inputs from multiple functions.
• Support and mentor Device Engineering team members, developing technical and leadership skills.
• Lead device selection and development activities; own and maintain the DHF, ensuring compliance with CSL quality system.
• Translate user needs and program strategy into product requirements, plans, milestones, and regulatory submissions.
• Lead risk management activities and implement control strategy across supply chains.
• Represent device engineering on cross-functional program teams and manage workplans and risk registers.
• Establish strong relationships with suppliers, vendors, and external partners to enable development and submission activities.
• Drive innovation through technology scouting and industry forum participation.
• Own program-level tracking of timelines, risks, decisions, and deliverables.

Jobbeschreibung

The Associate Director of Device Engineering is a leadership position in the Drug Delivery Systems & Packaging (DDSP) department within CSL’s Technical Operations. This role will report to the Director of Design Assurance.

Responsibilities

• Lead the Device Engineering team for drug–device combination product development across assigned assets, coordinating cross-functional inputs from Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Technical Operations, Supply Chain, Commercial, and external partners.
• Support and mentor Device Engineering team members, developing technical and leadership skills.
• Lead and coordinate device selection and development activities appropriate to the development stage, including inputs, outputs, verification and validation planning, supplier qualification, test strategy, documentation readiness, and regulatory submission support. Own and maintain the Design History File (DHF), ensuring documentation is complete, accurate, inspection-ready, and compliant with the CSL quality system and applicable regulatory frameworks for combination products.
• Translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables. Ensure alignment between device design, Primary Packaging, Secondary Packaging, Human Factors, and overall CMC/product strategy.
• Lead risk management activities, including hazard analysis, risk assessments, and mitigation planning. Plan and implement combination product control strategy across supply in alignment with CMC. Support human factors and usability activities to ensure the user interface, instructional materials, and intended-use considerations align with patient needs and regulatory expectations. Set and drive best practices within DDSP for Device Engineering, including standardized approaches for design risk assessment, biological evaluation, and other key deliverables.
• Represent the device engineering team on cross-functional program teams and ensure combination product deliverables are aligned with program needs. Create, manage, and execute integrated workplans, timelines, decision logs, meeting cadences, risk registers, and escalation pathways. Partner with project leads and development teams to ensure clear priorities, timely execution, and effective resolution of risks and dependencies.
• Establish and maintain strong working relationships with suppliers, vendors, OEMs, testing labs, CMOs, and other external partners to enable development, qualification, and submission-supporting activities. Support sourcing strategy, due diligence, and business development assessments related to combination products within the scope of technical expertise.
• Implement and approve end-to-end capabilities for drug–device combination development within Drug Product Development, including playbooks, templates, best practices, and knowledge-sharing approaches. Drive innovation through technology scouting and evaluation, identifying opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility. Represent CSL interests in industry forums such as ISO TCs and BioPhorum as well as sharing information from industry forums back to CSL colleagues.
• Own program-level tracking of timelines, risks, decisions, and deliverables to communicate progress clearly. Mentor Device Engineers, promote consistency across programs, monitor industry trends, standards, and regulatory guidance.

Education Requirements

Relevant academic qualification in an appropriate field, e.g., a suitable Science or Engineering degree.

Experience Requirements

• 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.
• Ability to influence and promote a culture of continuous improvement.

The role requires an ability to travel internationally up to 20%.