Job Overview
We are seeking a dynamic and innovative Senior/Staff engineer to join our cutting-edge biomedical engineering team. In this role, you will drive the development, design, and V&V studies of new TAVR aortic valves and delivery systems that improve patient outcomes. You will collaborate across multidisciplinary teams to translate clinical needs into reliable, compliant, and innovative products. Your expertise in engineering principles, regulatory standards, and research methodologies will be pivotal in bringing life-changing medical solutions from concept to production.
Duties
- Lead the design and development of medical devices using CAD software such as SolidWorks and other 3D modeling tools, ensuring mechanical robustness and compliance with industry standards.
- Draft detailed mechanical component and assembly designs, including the use of GD&T (Geometric Dimensioning and Tolerancing), to ensure precision manufacturing and assembly.
- Develop and execute test protocols and reports to optimize device performance, reliability, and manufacturability through rigorous testing.
- Perform benchtop experiments and design testing to validate/verify device functionality and safety.
- Analyze data statistically to support research findings, validate design choices, and prepare technical reports for regulatory submissions.
- Oversee junior engineer and technician duties to ensure compliance with company quality and manufacturing standards.
- Support clinical testing locally and abroad as required (10-15% travel).
- Additional duties as assigned.
- Work with design team to solve design issues and redesign as needed.
- Work with our international partner to meet international requirements and transfer technology.
Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, or related technical field.
- 4+ years of experience in an FDA regulated environment (structural heart preferred).
- Demonstrated ability to draft and execute multi-stage testing protocols and reports with well documented procedures and test data analysis.
- Experience testing structural heart implants, delivery systems, and/or accessories in bench top models in accordance with ISO and ASTM standards (ISO 5840, ISO 10555, etc.)
- Demonstrated proficiency in CAD software such as SolidWorks or equivalent for 3D modeling and product design.
- Understanding of quality and regulatory frameworks including FDA regulations, EUMDR, ISO standards (e.g., ISO 13485, ISO 14971, etc.), GLP (Good Laboratory Practice), CGMP (Current Good Manufacturing Practice), ASTM standards and design controls.
- Familiar with using statistical analysis software (JMP, Minitab) for research data interpretation and experimental design.
- Demonstrated multi-disciplinary problem-solving ability that leverages deep understanding of quality, engineering, and manufacturing processes to drive projects to completion.
- Excellent communication and technical writing skills.
Join us to be part of a passionate team dedicated to advancing healthcare technology through innovative engineering solutions!
Pay: $96,000.00 - $150,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
