Manufacturing Engineer II

Millenniumsoft•San Jose, CA

46d•Onsite

About The Position

This is a Manufacturing Engineer position with a potential contract to hire. The work shift is 1st Shift, 8am-4pm, onsite in San Jose, CA. The contract term is 12+ months with a weekly 40-hour work schedule. The 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. The engineer will continuously improve processes for optimal manufacturing efficiency, support new product introductions, review engineering designs and documentation for manufacturability, and evaluate/qualify new suppliers. They will interface with Product Development to define and implement manufacturability criteria, develop assembly procedures, and create test procedures for PCBs, systems, and sub-systems, including fixtures. The role ensures designs, documents, and procedures are validated in manufacturing before production release. The engineer will assess the feasibility of proposed engineering evaluation tests, products, or equipment, and may perform and document field failure investigations, identify root causes, and participate in corrective and preventative action efforts. Compliance with regulatory requirements and participation in Environmental, Health, and Safety programs are also key aspects of the role. The position requires the ability to work independently with general instructions, receiving technical guidance on complex issues and supervisory approval for project plans. The engineer must also be aware of and comply with basic regulatory requirements in their area of work and bring compliance questions to management's attention. Promoting a safe work environment, identifying hazards, and notifying supervisors of unsafe conditions are expected. The role also includes performing other related duties as assigned.

Requirements

BS degree: ME, EE, IE, Physics or other Technical degree.
3+ years 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.
Able 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.
Familiarity with ISO 9001 and 13485 standards.
Willingness to travel frequently.
Degree in Electrical or Mechanical Engineering.
Medical/Pharmaceutical work experience.
Ability to read electrical schematic and mechanical engineering drawings.
Familiarity with Oscilloscopes and Digital Multi-meters.
Experience creating Engineering Change Orders (ECO).
Stability with work history.

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.

Responsibilities

Determine root cause of difficult technical issues (mechanical, optical, electrical, and 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 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 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.
Performs other related duties and assignments as required.