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Sr. Manufacturing Engineer-Electrical/Mechatroni
Job Order #14144
Oakland, California - Added Mar 7, 2018

Full Description:

Our Client in the East Bay is looking for a highly skilled Mechanical engineer who wants to make an impact in the Medical Device industry.


If this is you, reach out ASAP! Open interview slots available this week!


Required / Desired:
1) Electro-Mechanical T/S Skills and Problem-Solving Skills – Required.
2) Great Communication and Soft Skills – Required.
3) Individual Contributor (No people-managers) – Be assertive, take initiative – ID problems – Run with it, and Fix it. – Required

• Medical Device Company experience – preferably noninvasive devices (stationary or hand-held) or equipment – small to capital, but could be invasive w/ exp such as catheters as stints.
• PLC experience – strong. Experience with PLC programming and LabVIEW. Ability to set up Test Fixtures (could involve scripting, preferably with LabView).
o Experience with developing production test fixtures.
o Experience in troubleshooting electro-mechanical systems.
o Knowledge of current statistical and analytical methods.
o Schematic and PCB design tools exp. desirable.
• Troubleshooting and Problem-Solving skills – strong exp. required – Use of all types of Test Equipment such as oscilloscope, logic analyzer, DVM, and Chip-scopes.

• Test protocol generation, execution, and reporting.
• FPGA’s – Understand how they operate, and preferably understand the system.
o Experience with microprocessor/microcontroller and/or FPGA based digital design.
• Knowledge of manufacturing documentation, such as BOM’s.
• Familiarity with IPC standards and the IEC 60601 family of safety standards a plus.
• CAP and/or 501K knowledge is helpful.
• Excellent organizational and verbal/written communication skills.
• Ability to work independently with little or no supervision.
• Experience in investigational analysis methods such as DFMEA, Design of Experiments a plus.
• Standards can be taught.
• 5+ Years exp required.
• Bachelor’s Degree in Electrical Engineering (BSEE) or Mechatronics Engineering (BSME or possibly an Industrial Engineering Degree) – Required.

Job Description:
• Be a bridge between R&D to Mfg Engineering for the purposes of new product realization, from Mfg. validation, to build, to shipping.
• Heavy in Documentation in a Mfg Eng environment, from the Medical Device and FDA perspective; lighter on design or hands-on E/M Engineering aspect.
• Ensure that all manufacturing related aspects of the company products are addressed throughout the product development cycle.
• Report into Manufacturing Dept. - Work closely with engineering, quality, and manufacturing operations to support the manufacturing of current and next generation products and improve manufacturing processes.
• Design and evaluate new and existing test fixtures and equipment, test methods, specifications, layouts, and standards.
• Test and troubleshoot electrical circuit boards – e.g. identify a design flaw, report a faulty component, id that the value of a resistor is incorrect, report that a diode is not properly installed, etc…
• Develop and validate test software.
• Apply expertise in system and board level electronics design to support optimizing for reliability, manufacturability, and testability.
• Conduct design reviews and other related technical reviews.
• Write or edit validation/test protocols/reports, write and implement engineering change notices (ECN’s).
• Lead sustaining projects and provide effort estimate and feasibility report.
• Develop and maintain documentation necessary to ensure the consistent manufacturing of products (processes, drawings, and shop floor paperwork).
• Provide engineering support for troubleshooting efforts for any process issues in designated area. Summarize and draws conclusions from test results leading to effective technical resolution of process problems.
• Identify, justify, and implement multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
• Identify and recommend manufacturing technologies to strategically develop business objectives and potential opportunities.
• Collaborate with manufacturing staff and management in other disciplines to develop, evaluate, and improve manufacturing methods.
• Apply statistical methods in evaluating and determining design parameters/limits.
• Conduct in-depth research to develop and introduce improved manufacturing methods. Analyze assembly processes to ensure quality results are achieved and sustained. Analyze data to determine return on investment (ROI).
• Work with production personnel, suppliers and contract manufacturers (CM’s) to establish or revise work instructions and production procedures.
• Ensure quality outcomes in device manufacturing areas by working with suppliers, quality systems, procurement, and sustaining engineering.
• Perform hazard analysis on new equipment and systems to ensure safe working conditions.
• Report project progress, issues and risks to supervisors.
• Work independently and normally receive little instruction on day-to-day work.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Mentor other staff as applicable.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.
• Development of manufacturing documentation (MP, IP, BOM).
• Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Will become the SME on all-things-electrical for the department.

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