Manufacturing Engineer II

Millenniumsoft•San Jose, CA

6d•Onsite

About The Position

The Manufacturing Engineer II (ME II) is a key contributor within the Instruments Manufacturing department. The ME II has both a manufacturing engineering and a project manager responsibility in working with projects or problems of small to moderate scope that require good judgment, with little management involvement, and will lead change, contribute new ideas, and find innovative methods to accomplish goals. The ME II is expected to have the ability to get things done through people that do not report to them. This role supports the introduction of new products into manufacturing as a member of an NPI program team. The ME II will establish processes and procedures, create assembly documentation, review engineering designs and documentation for completeness, clarity and manufacturability, evaluate and qualify new suppliers, and train production personnel. The role also involves utilizing and overseeing more junior engineers. The ME II authors or understands engineering drawings, Bills of Materials, routings, COGS, and operational procedures, and authors ECOs and implements them into the operational and commercial environment. This role provides hands-on support to the manufacturing assembly and test processes for flow cytometry instruments. The ME II must be an adept and experienced problem solver who is able to determine the root cause of difficult technical issues and implement effective solutions in a timely manner. The ME II incorporates Design-for-Manufacturability and Lean Manufacturing concepts into product and process design. They create defendable IQ/OQ/PQs to test and qualify new components, tools or process steps, and subsequently updates AMLs and ASLs, while working with internal teams and external suppliers/subcontractors for timely implementation of new materials and processes. The ME II may also perform and document field failure investigations, identify root cause, and participate in corrective and preventative action efforts. The ME II keeps abreast of the basic requirements for compliance in their own area of work and complies with those requirements, participates as required in training on regulatory issues affecting their own area of work, and brings regulatory compliance questions/issues to the attention of management. The ME II promotes a safe work environment, may provide recommendations on maintaining the safety of the work environment, participates in Environmental, Health and Safety programs, and addresses corrective actions whenever a hazard is identified. They notify health and safety authorities of all observed hazardous conditions or unsafe work practices.

Requirements

Typically requires a BS degree: ME, EE, IE, IT or equivalent
4-6 + years’ experience in a high tech manufacturing environment
Must be proficient in the use of personal computers: Microsoft Windows tools, including MS Project, Visio
Excellent written and verbal communication skills, must have good interpersonal skills: conflict resolution, negotiation, and time management skills
Must be able to understand engineering drawings, Bills of Materials, and operational procedures
Must have experience writing and reviewing Engineering Change Orders
Must have project management experience, lead continuous improvement efforts with cross functional teams
Experience developing manufacturing processes, writing procedures, and training assembly personnel
Work with quality and reliability teams to conduct risk analyses, FMEA reviews and able to define critical-to-quality criteria and present test plans for proposed changes or solutions.
Ability to be effective with minimal direction.
Recognizes problems and addresses them without waiting to be instructed to do so
Familiarity with ISO 9000 standards
Medical device or complex systems manufacturing experience
BOM, routings, manufacturing assembly documentation, tooling development experience
Solidworks experience

Nice To Haves

Proficiency with some of the following applications: Creo/Pro-E, Solidworks, AutoCAD, MS Project, MS Access, SAP ERP
Experience resolving technical issues involving lasers, optical components, fluidic systems or digital/analog circuitry.
Experience supporting some of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling
cGMP familiarity
21 CFR part 820, medical device manufacturing experience
Experience implementing Demand Flow Technology (DFT) processes
Experience utilizing Design-for-Manufacturability concepts
Experience implementing LEAN manufacturing processes
6 Sigma green or black belt

Responsibilities

Key member of, and sometimes lead, cross functional project teams in Manufacturing Operations.
Improve manufacturing operational efficiency, optimize product design, qualify replacement components or suppliers, improve product quality, improve customer satisfaction, or reduce manufacturing and material costs.
Support the introduction of new products into manufacturing as a member of an NPI program team.
Establish processes and procedures, create assembly documentation.
Review engineering designs and documentation for completeness, clarity and manufacturability.
Evaluate and qualify new suppliers.
Train production personnel.
Utilize and oversee more junior engineers.
Authors or understands engineering drawings, Bills of Materials, routings, COGS, and operational procedures.
Authors ECOs and implements into the operational and commercial environment.
Hands-on support to the manufacturing assembly and test processes for flow cytometry instruments.
Determine root cause of difficult technical issues and implement effective solutions in a timely manner.
Incorporate Design-for-Manufacturability and Lean Manufacturing concepts to product and process design.
Create defendable IQ/OQ/PQs to test and qualify new components, tools or process steps, and subsequently updates AMLs and ASLs, while working with internal teams and external suppliers/subcontractors for timely implementation of new materials and processes.
Perform and document field failure investigations, identify root cause, and participate in corrective and preventative action efforts.
Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
Participate as required in training on regulatory issues affecting own area of work.
Bring regulatory compliance questions/issues to the attention of management.
Promote a safe work environment.
Provide recommendations on maintaining the safety of the work environment.
Participate in Environmental, Health and Safety programs.
Address corrective actions whenever a hazard is identified.
Notify health and safety authorities of all observed hazardous conditions or unsafe work practices.