Manufacturing Engineer

BiVACOR Inc • Huntington Beach, CA

8d • Onsite

About The Position

The Manufacturing Engineer 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.

Requirements

• BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering
• 3-5 years engineering experience
• Skills in product and process development
• Skills in Manufacturing Engineering
• Superior communication skills
• Superior organizational skills
• Problem solving skills
• Technical skills
• Willingness to travel nationally and internationally
• Comfortable with complexity and ambiguity
• Ability to keep the bigger picture in mind

Nice To Haves

• MS desirable
• Experience preferably in the medical device industry
• Strong working knowledge of process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, TMVs is desirable.
• 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.

Responsibilities

• Contribute to the development of the design for manufacturing and assembly process of the BiVACOR rotary total artificial heart.
• Incorporate value engineering techniques.
• Work closely with management, internal company engineers, and external vendors to improve tooling and component quality.
• Investigate cost reduction and quality initiatives to assure the long-term value and viability of products.
• Optimize the device design and manufacturing process to reliably and repeatedly produce the implantable components of the device.
• Ensure components conform to design input specifications and meet product requirement specifications.

Benefits

• Competitive compensation package
• 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
• Discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level