Job Information
Actalent Manufacturing Engineer in Huntington Beach, California
Job Title: Manufacturing Engineer IIJob 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. The role involves assisting in transitioning production in-house over the next 1-2 years and supporting manufacturing and process development for complex Class 3 medical devices. The ME II will implement lean methodologies and support equipment upgrades and modifications, while also writing and documenting technical processes, protocols, and analysis reports.
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, including equipment identification, design, installation, and validation.
Manage internal and external resources 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.
Liaise technically with and coordinate 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 describing manufacturing and assembly of the device, including process time, capacity analysis, and manufacturing process maps.
Manage the design transfer to manufacturing and develop then verify internal/external manufacturing processes.
Schedule, order, manage vendor relations, and manage internal and manufacturing environments.
Verify the product and processes, including statistical process control and material traceability.
Develop test plans to identify and define the acceptable tolerance range that meets design input specifications and product output requirements.
Participate in failure analysis and 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.
Essential Skills
Experience with Class III medical devices
Design control
Process development
Lean manufacturing
Polymer processing
Process improvement
Manufacturing engineering
Validation
pFMEA
Additional Skills & Qualifications
BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering; MS desirable
3-5 years of engineering experience, including skills in product and process development, Manufacturing Engineering, preferably in the medical device industry
Strong working knowledge of process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, TMVs
Understanding of medical device quality regulations, practices, and quality standards, such as ISO and FDA quality system regulations (design controls)
Logistics and supply-chain experience
Familiarity with industry best practices and applicable standards
Work Environment
This role requires traveling 50% of the time to work with a vendor in Texas, managing product transfers. The company is a preclinical stage medical device startup with a current team of 22 employees, including technicians, engineers, a production manager, and mechanical engineers. The work environment includes medical device manufacturing, with generous benefits such as bonuses, 401K matching (up to 6%), 4% non-elective contribution, 4 weeks of vacation, stock options, and comprehensive health plans. Travel arrangements are well-supported with good hotel connections and extra baggage space.
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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.