What are the responsibilities and job description for the Mechanical Design (CAD) Engineer position at Lyndra Inc?
Company Overview
Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Our LYNX drug delivery platform transforms daily medicines into treatments that last a week or longer in a single oral dose. With the LYNX platform, we have the potential to fundamentally change how medicines are taken and delivered.
Position Overview
We are seeking a highly motivated and skilled Mechanical Engineer to join our innovative team. In this role, you will be responsible for the design, development, and implementation of novel pharmaceutical test and manufacturing equipment, ensuring it meets the highest standards of performance and compliance. Additionally, this role will oversee equipment maintenance, troubleshoot issues, and contribute to process development to support our cutting-edge product pipeline. A hands-on approach to learning and problem-solving will be required to support development efforts and drive critical programs forward. This role requires strong problem-solving abilities, technical expertise, and the capacity to work collaboratively across multidisciplinary teams.
Responsibilities :
- Lead the design, prototyping, and deployment of novel test and manufacturing fixture and equipment.
- Develop detailed mechanical drawings, 3D models, and system schematics using CAD tools (e.g., SolidWorks, AutoCAD).
- Specify materials, components, and systems to meet performance and regulatory requirements.
- Conduct simulations, feasibility studies, and design reviews to ensure optimal functionality and manufacturability.
- Establish and execute preventive maintenance schedules for test and manufacturing equipment.
- Diagnose and resolve mechanical or process issues to minimize downtime and ensure operational continuity.
- Train production and maintenance teams on equipment use, troubleshooting, and best practices.
- Partner with R&D and manufacturing teams to translate product requirements into scalable processes.
- Support process development in the implementation of robust manufacturing processes, ensuring repeatability and efficiency.
- Identify opportunities for continuous improvement in equipment and processes,
- Support process validation efforts, including IQ, OQ, and PQ protocols, in compliance with GMP and FDA / ISO standards. SME in manufacturing operations and equipment.
- Create and maintain technical documentation, including user manuals, SOPs, and maintenance records.
- Ensure all designs, processes, and equipment meet applicable safety, quality, and regulatory standards.
Qualifications :
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