Manufacturing Engineer (Medical industry experience; New Product Introduction)

Millenniumsoft•San Jose, CA

46d•Onsite

About The Position

The Manufacturing Engineer (ME) will be expected to simultaneously lead multiple high impact projects. The ME is expected to lead change, contribute new ideas, and find innovative methods to accomplish goals. Works on complex mechanical/electrical/electronic problems where of situations or data requires an in-depth evaluation of various factors. Acts independently, and exercises judgment within broadly defined practices and policies. May supervise the activities of others. Determines methods and procedures on new assignments. The ME will be expected to have the ability to get things done through people that do not report to them. The ME will also need to have the ability to work through adverse situations while building and maintaining good personal relationships.

Requirements

Typically requires a BS degree: ME, EE, IE, Physics or equivalent
8 + years experience in a high tech manufacturing environment
Must be 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, 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 extensive experience writing and reviewing Engineering Change Orders
Must have strong project management experience, Led continuous improvement efforts with cross functional teams
Experience developing manufacturing processes, writing procedures, and training assembly personnel
The ability to assess and resolve multiple high visibility problems in a timely manner.
The 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
Medical industry experience
New Product Introduction experience
Major – Electrical or Mechanical Engineering only

Nice To Haves

M.S. degree
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

Leads cross functional project teams. Major objectives may include: improving manufacturing operational efficiency, optimizing product design, qualifying replacement components, improving product quality, improving customer satisfaction, and reducing manufacturing costs.
Must be an adept and experienced problem solver who is able to determine root cause of difficult technical issues. Must be able to implement effective solutions in a timely manner. Issues are typically multi-disciplinary in nature: mechanical, optical, electrical, and fluidic.
Strives to continuously improve processes in order to achieve optimal efficiency for manufacturing operations.
Supports the introduction of new products into manufacturing. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Evaluates and qualifies new suppliers. Interfaces with Product Development to define and implement manufacturability criteria, develops procedures/processes for assembly, PCB's, systems and sub-systems test procedures including fixtures, during the development process. Ensures designs, documents, and procedures have been validated in manufacturing prior to production release.
Assesses feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data is insufficient or confirmation by testing is advisable.
Work is usually independently performed with general instructions as to the objectives expected; Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
The M.E. may perform and document field failure investigations, identify root causes, and participate in corrective and preventive action efforts.
Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental, Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
Performs other related duties and assignments as required.