Mechanical Engineer

Help Us Build the Future of the Human Heart.

At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.

About the Role

This role 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 Mechanical Engineer 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.

Key Responsibilities

• Create 2D-3D CAD drawings and models (SolidWorks).

• Ensure alignment of company manufacturing drawings at a consistent high-quality level under consideration of relevant standards.

• Ensure alignment of company 3D CAD models at a consistent high-quality level in terms of stability, flexibility, accuracy, and usability.

• Maintain product data management system (PDM).

• Undertake GD&T tolerance analysis as well as practices from ASME Y14.5.

• Design and manage manufacture of fixtures and tools for manufacturing.

• 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 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 creation of work instruction documentation which 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.

What You Bring

• 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 SolidWorks software (essential).

• Strong familiarization with ASME Y14.100, ASME Y14.5M (Geometric Dimensioning and Tolerancing, GD&T) (essential).

• Experience with management of a product data management system (desirable).

• Working knowledge of process and design characterization tools, e.g., pFMEAs, dFMEAs, IQ/OQ/PQ/PPQ, and TMVs (desirable).

• Strong technical or scientific writing/reporting skills (desirable).

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 401(k) with company matching

• Medical, dental, and vision insurance

• Health Savings Account (HSA) & Flexible Spending Account (FSA)

• Life insurance & Employee Assistance Program

• Generous paid time off

The expected salary range for this position based in Huntington Beach, California is $125,000 to $131,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employee