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 Manufacturing Engineer III. Come join the team where technical and business minds collaborate to focus on Replacing Hearts and Restoring Lives.

The Manufacturing Engineer III (ME III) will contribute to the development of the design for manufacturing and assembly process of the BiVACOR rotary total artificial heart, while incorporating value engineering techniques.

This position will work closely with management, internal company engineers, and external vendors to improve tooling 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 process to reliably and repeatedly produce the implantable components of the device, 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. The candidate must be comfortable with complexity and ambiguity, whilst keeping the bigger picture in mind.

RESPONSIBILITIES

• Conduct an extensive design for manufacturing review of current manufacturing processes in cooperation with key vendors.
  

• Develop and validate manufacturing processes from prototype to product.

• Equipment identification, design, installation and validation.
  

• Manage internal and external resources with a view to reduce cost and improve supply chain efficiency.

• Define product output specifications.

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

• Technically liaise with/coordinate and work with technicians.

• Review and Maintain 2D-3D CAD drawings.
  

• Implement GD&T analysis as well as practices from ASME Y14.5 and ASME Y14.100.

• Create work instruction documentation which describes manufacturing and assembly of the device and includes process time, capacity analysis, and manufacturing process maps
  

• Manage the design transfer to manufacturing and develop then verify internal/external manufacturing process.
  

• Scheduling, ordering, managing vendor relations, managing internal and manufacturing environment.

• Verify the product and processes including statistical process control, material traceability.

• Develop test plans to identify and define the acceptable tolerance range that meet design input specifications and product output requirement specifications.
  

• Participate in failure analysis / corrective action activities to determine and direct design modifications.

• Identify and manage process risk analysis and supplier management from prototype to product.

• Provide input and support to regulatory affairs for regulatory submission.

REQUIREMENTS

• BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering, MS desirable

• 5+ years engineering experience including skills in product and process development, Manufacturing Engineering, preferably in the medical device industry
  

• A strong working knowledge of process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, TMVs is desirable.

• An understanding of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations (design controls).

• Logistics and supply-chain experience is desired.

• Familiarity with industry best practices and applicable standards.

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

Compensation Range: $115,373 - $124,639 + 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 recognizing 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.