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BiVACOR Inc. is looking for a mechanical engineer (ME) with experience in medical devices.

This role, based at BiVACOR engineering office 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 team as required.

BiVACOR 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 TAH system.

- 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).

BiVACOR currently cannot provide relocation assistance.

At this time, we are unable to provide visa sponsorship. Candidates must be authorized to work in the US.

BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email hr@bivacor.com.