Manufacturing Engineer

Millenniumsoft•San Jose, CA

48d•Onsite

About The Position

The Manufacturing Engineer role requires an adept and experienced problem solver capable of determining the root cause of difficult, multi-disciplinary technical issues (mechanical, optical, electrical, and fluidic) and implementing effective solutions in a timely manner. This position focuses on continuously improving manufacturing operations for optimal efficiency, supporting new product introductions, and ensuring manufacturability of designs. The engineer will evaluate and qualify new suppliers, interface with Product Development to define manufacturability criteria, and develop assembly, PCB, and system test procedures. They will also assess the feasibility of engineering tests and ensure designs, documents, and procedures are validated before production release. The role involves performing and documenting field failure investigations, identifying root causes, and participating in corrective and preventative actions. Compliance with regulatory requirements and promoting a safe work environment are also key aspects of this position.

Requirements

BS degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Physics, or other Technical degree.
3+ years of experience in a high-tech manufacturing environment.
Proficient in the use of personal computers: MS Word, Excel, Power Point, MS Project, Visio, Windows or MAC OS.
Excellent written and verbal communication skills.
Good interpersonal skills: conflict resolution, negotiation, and time management skills.
Ability to understand engineering drawings, Bills of Materials, and operational procedures.
Extensive experience writing and reviewing Engineering Change Orders.
Strong project management experience.
Led continuous improvement efforts with cross-functional teams.
Experience developing manufacturing processes, writing procedures, and training assembly personnel.
Ability to assess and resolve multiple high visibility problems in a timely manner.
Ability to successfully interact with executive management.
Ability to be effective with minimal direction.
Recognizes problems and addresses them without waiting to be instructed to do so.
Willingness to travel frequently.

Nice To Haves

Proficiency with some of the following applications: Pro-E, AutoCAD, Solidworks, MS Project, MS Access, SAP ERP, Visio.
Experience resolving technical issues involving lasers and optical components.
Broad experience supporting many 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.
Strong cGMP familiarity 21 CFR part 820, medical industry experience.
Experience implementing Demand Flow Technology (DFT) processes.
Experience implementing LEAN manufacturing processes.
6 Sigma green or black belt.
Stability with work history.

Responsibilities

Determine root cause of difficult technical issues (mechanical, optical, electrical, fluidic) and implement effective solutions.
Continuously improve processes to achieve optimal efficiency for manufacturing operations.
Support the introduction of new products into manufacturing.
Review engineering designs and documentation for completeness, clarity, and manufacturability.
Evaluate and qualify new suppliers.
Interface with Product Development to define and implement manufacturability criteria.
Develop procedures/processes for assembly, PCB's, systems and sub-systems test procedures including fixtures, during the development process.
Ensure designs, documents, and procedures have been validated in manufacturing prior to production release.
Assess feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
Perform and document field failure investigations, identify root causes, and participate in corrective and preventative action efforts.
Keep abreast of basic requirements for compliance in own area of work and comply with those requirements.
Participate 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 and participate in Environmental, Health and Safety programs.
Address corrective actions whenever a hazard is identified.
Notify supervisor of all observed hazardous conditions or unsafe work practices.
Perform other related duties and assignments as required.