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Description

The Manufacturing Engineer II (ME II) will contribute to the development of the design for manufacturing and assembly process of the rotary total artificial heart, while incorporating value engineering techniques. Assist in transitioning production in-house over the next 1-2 years. Support manufacturing and process development for complex medical devices (Class 3). Implement lean methodologies and support equipment upgrades and modifications. Write and document technical processes, protocols, and analysis reports. - 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. o Equipment identification, design, installation and validation. o Manage internal and external resources with a view to reduce cost and improve supply chain efficiency. o Define product output specifications. - Plan, schedule, conduct and coordinate detailed phases of engineering work relating to manufacturing. o Technically liaise with/coordinate and work with technicians. o Review and Maintain 2D-3D CAD drawings. o Implement GD&T analysis as well as practices from ASME Y14.5 and ASME Y14.100. o 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. o Scheduling, ordering, managing vendor relations, managing internal and manufacturing environment. o Verify the product and processes including statistical process control, material traceability. o Develop test plans to identify and define the acceptable tolerance range that meet design input specifications and product output requirement specifications. o Participate in failure analysis / corrective action activities to determine and direct design modifications. o Identify and manage process risk analysis and supplier management from prototype to product. o Provide input and support to regulatory affairs for regulatory submission.

Skills

class iii medical devices, design control, process development, lean manufacturing, polymer, process improvement, Manufacturing engineering, validation, pfmea

Top Skills Details

class iii medical devices,design control,process development

Additional Skills & 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 characterisation, 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.

Experience Level

Entry Level

Pay and Benefits

The pay range for this position is $90000.00 - $110000.00/yr.

Company provides standards benefits, Holiday pay, PTO

Workplace Type

This is a fully onsite position in Huntington Beach,CA.

Application Deadline

This position is anticipated to close on Aug 11, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.