Some opportunities happen only once in a lifetime – like choosing a position where you have the chance to change lives. BiVACOR is a preclinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. We're a team of hard-working, high performing specialists looking to grow our Huntington Beach, CA location and hire a Mechanical Engineer IV. Come join the team where technical and business minds collaborate to focus on Replacing Hearts and Restoring Lives.

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 manufacture of the BiVACOR Total Artificial Heart (TAH). The ME will also collaborate with internal company engineers and external design and manufacturing vendors 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 manufacturing of all implantable/mechanical subsystems, i.e., pump, fluid and electrical connectors, drivelines, and implant tools.

- Technical contribution to the development and manufacturing of tooling and jigs required for the development and manufacturing of the implantable/mechanical subsystems.

- Develop and validate manufacturing processes including equipment identification, design, installation, and qualification.

- Liaise with external suppliers as required for the manufacture and assembly of mechanical components.

- Liaise with/coordinate the work of technicians.

- Maintain and create 2D-3D CAD drawings and models (SolidWorks).

- Maintain product data management (PDM) system.

- Create work instruction documentation which describes manufacturing of the device.

- Assist with the quality assurance team to ensure manufactured products comply to requirements and standards.

- Assist with the verification and validation team with testing elements of the TAH.

- Undertake GD&T tolerance analysis as well as practices from ASME Y14.5 and ASME-Y14.100.

- Conduct manufacturing inspections and inspection documentation.

- Assist in risk analysis and design control activities regarding the implantable system and processes.

REQUIREMENTS

- Bachelor’s Degree in Mechanical Engineering or higher (essential).

- 5 – 8 years’ experience in the complex mechanical design, electronic design, development, and manufacturing of medical devices (desirable).

- Familiarization with ASME Y14.100, ASME Y14.5M-2009, ANSI/AAMI/ISO 14708-5:2010 (desirable).

- Working knowledge of process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs (desirable).

- 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).

Occasional travel may be required, up to 2 weeks per year.

Compensation Range: $125,000 – $140,000 + bonus + benefits

The above represents the expected salary range for this job requisition. Ultimately, in determining pay, we’ll consider job location, experience, and other job-related factors.

BiVACOR offers a competitive compensation package to include a 401k with match, generous time off, a choice of healthcare plans and an array of other benefits. In addition, this position will be eligible for short-term and long-term incentive programs.

About the Company

BiVACOR® is a preclinical 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 Houston, TX with an engineering office in Huntington Beach, CA, and 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 Surgical 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 of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognising those around us. To learn more about us go to www.bivacor.com

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

BiVACOR does not accept profiles or resumes from recruiting firms without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by BiVACOR, implied or otherwise.