Manufacturing Engineer

Overview Help Us Build the Future of the Human Heart. At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. About the Role The Manufacturing Engineer will contribute to 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. Location 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 Responsibilities are described above as part of the role content. (This section consolidates the core job duties into a cohesive narrative.) Qualifications BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering, MS desirable 3-5 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. Benefits What We Offer BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching Medical, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Life insurance & Employee Assistance Program Generous paid time off The expected salary range for this position based in Huntington Beach California is $110,000 - $130,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr BiVACOR Inc