Device Project Leader

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Oversee assigned drug-delivery device and combination-product projects from the initial phase through development, industrialization, submission, launch readiness, and lifecycle management.

• Convert device and product-presentation strategies into cohesive project plans.

• Collaborate with cross-functional teams and external partners to ensure delivery meets scope, quality, timeline, budget, and risk objectives.

• Manage project plans that outline deliverables, milestones, dependencies, resources, budget, risks, decisions, and escalation processes.

• Lead cross-functional device project teams throughout development, industrialization, clinical supply, registration, and launch readiness phases.

• Track performance, evaluate trade-offs, initiate recovery or contingency measures, and provide updates to leadership.

• Organize project-team and design-review meetings, documenting decisions, actions, owners, and due dates.

• Facilitate the development of prefilled syringes, safety systems, autoinjectors, large-volume or on-body delivery systems, secondary packaging, and user instructions.

• Integrate user, product, technical, manufacturing, quality, regulatory, clinical, and commercial requirements into project execution.

• Supervise design-control deliverables, including design inputs and outputs, design reviews, verification, validation, usability engineering, risk management, design transfer, and technical documentation.

• Ensure that Design History File deliverables are properly planned, assigned, traceable, review-ready, and aligned.

• Act as the operational liaison across CMC, Regulatory, Quality, Clinical, Clinical Supply, Manufacturing, Commercial, Procurement, Finance, and other departments.

• Manage governance with device manufacturers, technology partners, CDMOs, testing laboratories, human-factors providers, consultants, and packaging suppliers.

• Integrate partner plans and deliverables, contribute to statements of work and budgets, monitor performance, and escalate risks as necessary.

• Incorporate regulatory, quality, design-control, risk-management, and human-factors requirements into project execution.

• Manage device documentation and submission content while supporting regulatory responses.

• Coordinate formative and validation human-factors activities and translate findings into design, labeling, risk-management, and submission actions.

• Ensure adherence to internal procedures and global device and combination-product standards.

⛳️ Requirements

• A Master's degree in life sciences, engineering, pharmaceutical sciences, or a related field, or equivalent relevant experience.

• Generally, 10+ years of pertinent experience in the pharmaceutical, biotechnology, or medical device sectors.

• Extensive experience in combination-product development and leading cross-functional projects.

• Proven track record of guiding multidisciplinary teams through significant development milestones.

• Strong understanding of design controls, risk management, human factors, design transfer, industrialization, and technical documentation processes.

• Experience in managing external development, technology, manufacturing, or testing partners.

• Solid grasp of parenteral drug-product development, primary packaging, drug-device interfaces, and regulatory requirements in major markets.

• Exceptional English communication skills.

• Willingness to travel for partner engagements, study, and manufacturing-site activities.

🏝️ Benefits

• Short-term incentives program.

• Long-term incentives program.

• Equal consideration in an inclusive environment.

• Equal opportunity employment.