Device Project Lead

Polpharma Biologics develops biosimilar monoclonal antibodies for global markets. Our products rely on advanced drug-device combination solutions, including prefilled syringes, autoinjectors, needle-safety systems and large-volume subcutaneous delivery platforms.

We are looking for an experienced Device Project Lead to take end-to-end ownership of device development programmes—from user needs and design inputs through verification, validation and design transfer to submission and launch. You will lead cross-functional specialists and external partners while ensuring that our devices can be transferred, manufactured and supplied reliably.

• Own the device strategy, development plan, milestones, priorities, budget, resources and risk management for assigned programmes.
• Represent Device Development in technical and cross-functional programme teams and contribute to integrated plans and budgets.
• Provide device input to regulatory submissions and authority interactions, including EU MDR Article 117, EMA and FDA requirements.

• Coordinate experts across Device Technology, Risk Management, Human Factors, Packaging, Technical Transfer, Regulatory Affairs and Quality Assurance in a matrix environment.
• Drive development in line with design control requirements, including user needs, design inputs and outputs, traceability, verification, validation, transfer and change management.
• Own the Design History File, lead design reviews and ensure deliverables are complete, consistent and submission-ready.
• Integrate technical, quality, regulatory, timeline and cost considerations into balanced, risk-based decisions.

• Act as the department’s reference for device technology, manufacturability, design transfer and industrialisation across the portfolio.
• Oversee specifications, control strategies, testing and validation for devices, components, assembly, labelling and packaging processes.
• Build the device technology and supplier landscape, evaluate platforms and lifecycle options, and support second sourcing and cost-of-goods improvements.

• Serve as technical lead for device suppliers, component manufacturers, assembly partners and fill-finish CMOs.
• Support supplier selection and qualification, technical and quality agreements, investigations, validation activities and supply-chain robustness.

• MSc or equivalent in mechanical, biomedical, process or pharmaceutical engineering, or a related technical discipline.
• At least eight years of experience in medical device or drug-device combination product development within pharma, biotech or Med Tech.
• Proven end-to-end leadership of device development projects under design control, including cross-functional teams, external partners, planning and budgets.
• Hands-on experience with design transfer, industrialisation and device manufacturing at CMOs or suppliers.
• Experience with parenteral delivery systems such as prefilled syringes, autoinjectors, pen injectors, needle-safety devices or on-body injectors.

You do not need to be the specialist in every discipline, but you should be able to lead, integrate and challenge work across:

• Design control and quality systems, including ISO 13485, 21 CFR 820, 21 CFR Part 4 and EU MDR Article 117.
• Risk management and human factors, including ISO 14971 and IEC 62366-1.
• Primary and secondary packaging, labelling, container-device compatibility and relevant standards.
• Device verification and validation, technical transfer, GMP manufacturing and process validation.
• Combination product submissions and interactions with Notified Bodies and health authorities.

• You are a natural cross-functional leader who aligns specialists, partners and stakeholders behind one plan.
• You work in a structured, pragmatic and accountable way and confidently drive decisions.
• You combine technical depth with project and business thinking, including cost and supply considerations.
• You communicate clearly with suppliers, CMOs and senior management and thrive in an international, partly remote organisation.
• You are fluent in English;
  German or another European language is an advantage. Lean or Six Sigma qualifications are also welcome.

• A key role with real…