Job Description: Summary
The Senior 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 analysis 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.
Responsible for developing, implementing, and maintaining methods, operation sequence and processes in the fabrication of parts, components, subassemblies, and final assemblies. Estimates manufacturing cost, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines.
Develop the required documentation to support processes and provide training to technicians. Work with technicians to troubleshoot complex issues and provide unambiguous plan of action.
Execute and refine build sequences specific to optics integration, optics alignment and system calibrations. Evaluate the manufacturing effectiveness of a build process and implement improvements to meet build cycle times and product design specifications. As required, maintain records and reporting systems for coordination of manufacturing operations.
Test and qualify optical components and modules. Work with suppliers to improve incoming material quality and acceptance.
Support the manufacturing team on escalations related to laser alignment.
Interface with engineering in coordinating the release of new products. Learn and understand the requirements/architecture of next generation subsystems.
Read and interpret design drawings, schematics, and perform simple updates of models or drawings using computer-aided design (such as Zemax) tools. Interpret some system models of error, sensitivity, or throughput budgets that pertain to optics alignment.
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. .
May perform and document field failure investigations, identify root causes, and participate in corrective and preventative 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.
A BS degree (required): in Optics/Physics, or Optical/Mechanical/Electrical Engineering.
8 + years experience in a high tech manufacturing environment
Minimum 3 years experience with lasers, optics, and optical components
Working knowledge of Optical Standards such as MIL-PRF-13830 or ISO 10110
Familiarity with ISO 9001 and 13485 standards
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
Willingness to travel when needed
Additional skills/Preferred Qualifications
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
Primary Work Location
USA CA - San Jose
US BD 1st Shift 8am-4pm (United States of America)
BD (Becton, Dickinson And Company)