Your mission
Are you a technical expert with a passion for innovation in the medical device industry? Join PULMOTREE as a Technical Lead for Partnering Programs and Customization, where you’ll play a pivotal role in advancing our proprietary device platforms for combination products.
In this role, you’ll lead the customization of cutting-edge medical devices, managing processes such as usability, documentation, V&V testing, and risk management. You’ll ensure that all device development aligns with industry standards, regulatory requirements, and customer specifications. As part of the PULMOTREE R&D team, you’ll bring your expertise to complex technical challenges, driving projects to successful outcomes in a highly regulated environment.
If you’re passionate about developing innovative, high-quality solutions and thrive in a detail-oriented technical role, we’d love to welcome you to our team!
Your responsibilities:
In this role, you’ll lead the customization of cutting-edge medical devices, managing processes such as usability, documentation, V&V testing, and risk management. You’ll ensure that all device development aligns with industry standards, regulatory requirements, and customer specifications. As part of the PULMOTREE R&D team, you’ll bring your expertise to complex technical challenges, driving projects to successful outcomes in a highly regulated environment.
If you’re passionate about developing innovative, high-quality solutions and thrive in a detail-oriented technical role, we’d love to welcome you to our team!
Your responsibilities:
- Technical Customization of Nebulizer Platform: Leads new product development and oversees the technical adaptation of the Nebulizer platform to meet specific requirements.
- Design Deliverables Execution: Prepares and manages design deliverables in line with the Product Development Process, including V&V (Verification & Validation) plans, user risk management, and product safety compliance (ISO 10993, IEC 60601-1, etc.).
- Master Test Plan Development: Creates comprehensive master test plans covering design verification, design validation, and process validation activities.
- Reliability Studies and Experimental Evaluations: Designs, coordinates, and executes technical reliability studies and evaluates engineering design concepts using Design of Experiments (DOE) methodologies.
- Improvement of Lung Deposition Models: Enhances and optimizes Lung Deposition Models to support product innovation and performance.