Mechanical Engineer III – CAD

This role, based at the BiVACOR engineering office in Huntington Beach, CA, will support the mechanical engineering team with engineering activities for the development, design, and non-clinical manufacture of the BiVACOR Total Artificial Heart (TAH). The ME will also collaborate with internal company engineers and external design and manufacturing suppliers for the TAH development, as well as support the BiVACOR quality assurance, and verification and validation teams as required.

BiVACOR is seeking motivated team members eager 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.

KEY RESPONSIBILITIES

• Create 2D-3D CAD drawings and models (Solid Works).
• Ensure alignment of company manufacturing drawings to a consistent, high-quality standard, in accordance with relevant standards.
• Ensure alignment of company 3D CAD models at a consistent high-quality level in terms of stability, flexibility, accuracy, and usability.
• Undertake GD&T tolerance analysis as well as practices from ASME Y14.5.
• Design and manage the manufacture of fixtures and tools.
• 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, drive lines, and implant tools.
• Plan, perform, and analyse results of analytical, experimental, and numerical design studies.
• 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.
• Support in the creation of work instruction documentation that describes manufacturing and testing.
• Assist the verification and validation team with testing elements of the TAH system.
• Assist in submissions to regulatory bodies and scientific journals.
• Assist in risk analysis and design control activities regarding the mechanical system and processes.

REQUIREMENTS – QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree or higher in mechanical engineering (essential).
• Minimum 4+ years’ experience in mechanical design, development, and manufacturing (essential), in the field of medical devices or specifically mechanical circulatory support (desirable).
• Substantial experience with Solid Works software (essential).
• Strong familiarisation with ASME Y14.100, ASME Y14.5M (Geometric Dimensioning and Tolerancing, GD&T) (essential).
• Experience with the management of a product data management system (desirable).
• Working knowledge of process and design characterisation tools, e.g., pFMEAs, dFMEAs, IQ / OQ / PQ / PPQ, and TMVs (desirable).
• Strong technical or scientific writing/reporting skills (desirable).
• An understanding of device quality standards, such as ISO 13485, ISO 9001 (essential).
• Experience with Design of Experiments or optimization methods (desirable).

BiVACOR ® is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia.

Our highly driven and performing team has complementary science and business minds to focus on “Replacing Hearts and Restoring Lives.”

Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team…