Manufacturing Electrical Engineer at BiVACOR

MANUFACTURING ENGINEER II (Electrical)

The Manufacturing Engineer II (Electrical) will be responsible for manufacturing process analysis, improvement, and validation of the BiVACOR rotary total artificial heart with a focus on peripheral components (batteries, AC Adapters, tablet computers etc.) and all electronic assemblies and 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 process flow to reliably and repeatedly produce the external subsystems, which conform to the design input specification and meet the product requirement specifications.

For the location in Huntington Beach (CA), BiVACOR is looking for motivated and flexible team members with superior communication and organizational skills, who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility to find the best solution in a multidisciplinary and dynamic R&D environment. Strong initiative in a team environment, organizational, time/project management and technical skills are required.

RESPONSIBILITIES

• Develop, analyze, improve, and validate manufacturing processes with a focus on the peripheral components and all electronic assemblies and subassemblies.
• Equipment identification, design, installation, and validation.
• Define and improve the assembly workflow, work instructions, inspection points, and in-process test requirements for electronic subsystems.
• Develop test plans to identify and define the acceptable tolerance range that meet design input specifications and product output specifications.
• Manage internal and external resources with a view to reduce cost and improve supply chain efficiency.
• Create and optimize work instruction documentation which describes manufacturing and assembly.
• Define product output specifications relating to manufacturing processes.
• Implement and maintain requirements, equipment, and procedures for best practices in the handling and assembly of ESD-sensitive components and assemblies.

• 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 Electrical, Mechanical, or Manufacturing Engineering (essential), MS desirable.
• 3-5 years manufacturing experience including skills in process development for electronic assemblies, Manufacturing Engineering, preferably in the medical device industry (essential).
• A strong working knowledge of process characterization 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).
• Working knowledge in the analysis of circuit behavior and in root-cause analysis for electronic malfunctions including the use of electronic equipment such as oscilloscopes, and multi-meters (desirable).
• Experience with Design of Experiments or optimization methods (desirable).
• Experience in logistics and supply-chain (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”. 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.