MANUFACTURING (MECHANICAL) ENGINEER II

The Manufacturing (Mechanical) Engineer II (MFG ENG II) will be responsible for manufacturing process analysis, improvement, and validation of the BiVACOR rotary total artificial heart with a focus on the implantable polymeric subassemblies.

This position will work closely with management, internal company engineers, and external vendors to improve process and component quality, whilst also investigating cost reduction and quality initiatives to assure the long-term value and viability of products. This position aids in optimizing the device design and manufacturing processes to produce the implantable components of the device reliably and repeatedly, which conforms to the design input specification and meets the product requirement specifications.

Located in Huntington Beach, CA, we are looking for a hands-on candidate with superior communication and organizational skills as well as problem solving and technical skills and a willingness to travel nationally and internationally. Due to outsourced manufacturing, the candidate must be willing to travel nationally to suppliers for up to 50% of the time. The candidate must be comfortable with complexity and ambiguity, whilst keeping the bigger picture in mind.

RESPONSIBILITIES:

- Develop, analyze, improve, and validate manufacturing processes with a focus on the implantable polymeric subassemblies.

• Equipment identification, design, installation, and validation.
• Manage internal and external resources with a view to reduce cost and improve supply chain efficiency.
• Validate processes using statistical process analysis.
• Develop test plans to identify and define the acceptable tolerance range that meet design input specifications and product output specifications.
• Create and optimize work instruction documentation which describes manufacturing and assembly.
• Define product output specifications relating to manufacturing processes.

- Plan, schedule, conduct and coordinate detailed phases of work relating to manufacturing.

• Support in scheduling, ordering, managing vendor relations, managing internal and manufacturing environment.
• Participate in failure analysis and corrective action activities to determine and direct design and process modifications.
• Technically liaise with, coordinate, and work with technicians.

- Support in risk analysis, requirement definition and regulatory submissions.

• Support and manage process risk analysis including key suppliers.
• Support in requirements definition.
• Provide input and support to regulatory affairs for regulatory submission relating to process or material changes.
• Support in a design for manufacturing review in cooperation with internal engineers and key vendors.

REQUIREMENTS:

• BS in Mechanical or Manufacturing Engineering (essential), MS desirable.
• 3-5 years manufacturing experience including skills in process development, Manufacturing Engineering, preferably in the medical device industry (essential).
• A strong working knowledge of process characterisation and validation including tools such as pFMEAs, MVP, IQ / OQ / PQ / PPQ, TMVs (essential).
• An understanding of medical device quality regulations, practices, and quality standards, such as ISO 13485 and FDA quality system regulations (essential).
• Experience with Design of Experiments or optimization methods (desirable).
• Experience in logistics and supply-chain (desirable).
• Experience in synthesis and processing of polymers (desirable).
• Experience with cleanroom manufacturing and cleanroom installation and setup (desirable).

BiVACOR offers a competitive compensation package to include 401k with above-average employer contributions, generous amount of time off, a choice of rich healthcare plans and an array of other benefits.

About the Company

BiVACOR is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions. 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 recognizing those around us. To learn more about us go to

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

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.