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Manufacturing Engineer IV

Job description

Our client is looking for a mechanical engineer (ME) with experience in medical devices. This role, based at our client's engineering office in Orange County, CA, will support the mechanical engineering team with engineering activities for the development, design, and non-clinical manufacture of their class III implantable products. The ME will also collaborate with internal company engineers and external design and manufacturing suppliers for the development of these products, as well as support our client's quality assurance and verification and validation team as required.

Our client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility in a multidisciplinary and dynamic environment. Besides technical capabilities, time management and organizational skills are required to work towards a certified environment.

RESPONSIBILITIES
  • Technical contribution to the development and design of all implantable/mechanical subsystems under consideration of the scientific/technical state of the art, i.e., pump, fluid and electrical connectors, drivelines, and implant tools.
  • Plan, perform, and analyze results of analytical, experimental, and numerical design studies.
  • Technical contribution to the patient controller design and development with regards to electronics packaging and mechanical design.
  • Liaise with external suppliers as required for the manufacture and assembly of non-clinical prototypes, components, and assemblies.
  • Liaise with/coordinate the work of technicians.
  • Maintain and create 2D-3D CAD drawings and models (SolidWorks).
  • Maintain product data management system (PDM).
  • Support in creation of work instruction documentation which describes manufacturing and testing.
  • Assist with the verification and validation team with testing elements of the class III implantable products.
  • Draft submissions to regulatory bodies and scientific journals.
  • Undertake GD&T tolerance analysis as well as practices from ASME Y14.5 and ASME-Y14.100.
  • Assist in risk analysis and design control activities regarding the implantable system and processes.
 
REQUIREMENTS
  • Bachelor’s degree in mechanical engineering (essential), master’s degree or PhD (preferred).
  • 7+ years’ experience in the mechanical design, development, and manufacturing of medical devices (essential), specific experience in the field of mechanical circulatory support (preferred).
  • Familiarization with ASME Y14.100, ASME Y14.5M, ANSI/AAMI/ISO 14708-5:2010 (desirable).
  • Working knowledge of process and design characterization, pFMEAs, dFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs (desirable).
  • Strong technical or scientific writing/reporting skills (essential).
  • An understanding of device quality standards, such as ISO 13485, ISO 9001 (essential).
  • Experience with SolidWorks or other CAD software (essential).
  • Experience with Design of Experiments or optimization methods (desirable).
  • Experience with Matlab MathWorks (desirable).
  • Experience with FEA/CFD analysis (desirable).