BioTalent Ltd
Our client is seeking a Senior or Staff level Mechanical Engineer (ME) with experience in medical devices. This position, based at our client's engineering office in Orange County, CA, involves supporting the mechanical engineering team in the development, design, and non-clinical manufacturing of Class III implantable products. The ME will collaborate with internal engineers and external suppliers, and support quality assurance, verification, and validation teams as needed.
We are looking for motivated team members eager to contribute to an active and dynamic project environment. This role requires creativity, flexibility, and strong organizational skills to operate within a certified environment.
Responsibilities
- Contribute technically to the development and design of implantable/mechanical subsystems, including pumps, fluid and electrical connectors, drivelines, and implant tools.
- Plan, perform, and analyze analytical, experimental, and numerical design studies.
- Contribute to the design and development of patient controllers, focusing on electronics packaging and mechanical design.
- Coordinate with external suppliers for manufacturing and assembly of prototypes and components.
- Coordinate work of technicians.
- Maintain and create 2D/3D CAD drawings and models using SolidWorks.
- Manage product data using the PDM system.
- Create work instructions for manufacturing and testing processes.
- Assist with testing elements of Class III implantable products in verification and validation activities.
- Draft regulatory submissions and scientific publications.
- Perform GD&T tolerance analysis following ASME Y14.5 and Y14.100 standards.
- Support risk analysis and design control activities for the implantable system and processes.
Requirements
- Bachelor’s degree in Mechanical Engineering (required); Master’s or PhD (preferred).
- At least 7 years of experience in mechanical design, development, and manufacturing of medical devices, with specific experience in mechanical circulatory support (preferred).
- Familiarity with standards such as ASME Y14.100, Y14.5M, and ANSI/AAMI/ISO 14708-5:2010.
- Knowledge of process and design characterization methods, including pFMEAs, dFMEAs, MVP, IQ/OQ/PQ, and TMVs.
- Strong technical writing and reporting skills.
- Understanding of device quality standards like ISO 13485 and ISO 9001.
- Proficiency in CAD software, especially SolidWorks.
- Experience with Design of Experiments or optimization methods (preferred).
- Experience with Matlab MathWorks (preferred).
- Experience with FEA/CFD analysis (preferred).