Bern, Berne, Switzerland
Global Engineering & Device Development Leader with 25 years of experience in parenteral drug delivery systems, primary packaging, and combination products. I lead international teams, shape long‑term device platform strategies, and drive lifecycle excellence from early development to commercial launch. Recognized across the industry with a broad professional network and strong visibility through ISO, PDA, and cross‑company collaboration. Passionate about innovation, team development, and delivering compliant, patient‑centric solutions.
Leadership • Defined and executed global technology strategies for primary packaging, medical devices, and combination products, shaping long term platform architectures and harmonization across sites. • Built, led, and developed high performing global teams through recruitment, mentoring, succession planning, and talent development, fostering a strong, values driven culture with high employee engagement. • Mentored high potential technical talent, establishing a sustainable leadership pipeline in packaging and device engineering. • Led cross functional teams across the full product lifecycle, from development through launch and lifecycle management. • Actively contributed to international standards bodies and expert forums (e.g., ISO, PDA). Delivery • Led end to end development and industrialization of device platforms, including autoinjectors, needle safety devices, and transfer systems. • Directed CDMO and supplier partnerships, ensuring design integrity, on time delivery, and strategic alignment across complex portfolios. • Ensured submission ready, regulatory compliant documentation for global registrations (FDA, EMA). • Delivered full compliance with ISO 11607, ISO 13485, FDA, and EU MDR/IVDR across development, validation, and lifecycle management. • Led development, validation, and commercial change management for sterile barrier systems, combination products, and primary packaging. External Engagement • Represented company interests in Swiss norms, ISO, and PDA committees
Leadership • Defined and executed global strategies for device and packaging development aligned with corporate objectives. • Led global development programs for prefilled syringes, autoinjectors, and device related combination products in line with global regulatory requirements. • Held strategic ownership of DHFs, risk management files, FMEAs, and full design control documentation across multiple device platforms. • Built and developed high performing, globally distributed teams in primary packaging and medical devices through recruitment, mentoring, training, and succession planning. • Fostered a strong, values driven team culture with high employee engagement and a shared sense of ownership. • Planned and controlled budgets and resources across all PPMD development projects. Delivery • Represented and led PPMD input in early stage development programs. • Directed preparation of submission ready documentation for global regulatory agencies (FDA, EMA). • Delivered complex portfolio projects within agreed time, cost, and quality, enabling competitive, filing ready devices, combination products, and production processes. • Authored key SOPs for the combination product area (e.g., control strategy, design transfer). • Ensured all combination product projects were executed under design control and a risk based approach (21 CFR 820, ISO 13485, EU MDR Annex I). • Established verification laboratories in Bern and Marburg, including CAPEX planning and process implementation. External Engagement • Represented company interests in Swiss norms, ISO, and PDA committees and served as expert contributor to the medical technology program at Bern University of Applied Sciences.
Leadership • Provide leadership and manage section as a highly effective device development organizational group within technical development. Contribute effectively as a member of device development leadership team • Led globally distributed teams across multiple sites, fostering a culture of collaboration and high performance • Led cross-functional teams to deliver on project goals throughout the entire product lifecycle—from development to launch and lifecycle management • Develop and maintain own section/team strategy • Plan resource demands for own area of responsibility. Identify and justify functional spending requirements. Manage budget planning and actuals to meet agreed targets • Develop and coach divers team members • Create a positive team atmosphere, which is essential for the achievement of the goals Delivery • Ensured end‑to‑end compliance with ISO 11607 and ISO 13485 for sterile barrier and medical device packaging, aligning with FDA and EU MDR/IVDR requirements across development, validation, and lifecycle management. • Execute portfolio projects within the agreed time – quality – cost frame resulting in state- of –the-art and competitive devices and related combination products and production processes ready for filing. Provide high quality input and documentation for interaction with regulatory authorities • Accomplish all combination product project under design control and risk-based approach (cfr210. 820 and ISO 13485) • A lot of experience in the field of audit, this includes both sides/parties • Medical device representative of several divers due diligent programs External • Preparation, alignment and active joint steering committee, joint management team, supplier relationship meeting participation for assigned CMO(s)/supplier and technical development teams • Prepared, aligned and active external working group/industry forum/ISO committee participation.
Leadership • Definition of product strategy, quality standards and product • Innovation management based on market and customer requirements • Coordination of sales plans to guide sellers, business development and product manager • Technical feasibility analysis, budgeting, profitability and portfolio complexity • Decision on business opportunities and price policy • Determination of operating performance indicators
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