Senior Manufacturing Engineer (Req #317) OptiMedica
THIS JOB HAS EXPIRED We are looking for an experienced Senior Manufacturing Engineer (Req#317) to support the production of its expanding line of innovative ophthalmic instruments. You must be familiar with electrical and electronic best practices and have ability to quickly solve challenging problems. Strong skills and experience in analog and digital electronics design, analysis and testing. You will actively participate in component selection and specification across multiple projects. Must be able to work with limited guidance/supervision and be able to test, evaluate, document, qualify and release designs for complex projects involving medical laser equipment.
Will work in a team environment with other engineers (of varied disciplines) as well as management and manufacturing personnel to sustain/improve existing products and
deliver new products to market.
Interested in applying or learning more, please contact email@example.com ? please reference the requisition number and the job title.
Applies electrical and electronic engineering principles and concepts to evaluate new designs for function and performance. System integration of new components and
designs into high performance optical and opto-mechanical systems and sub-systems.
Perform system level troubleshooting and repairs of complex controls including FPGA hardware and software.
Create diagnostic and troubleshooting programs using Labview for complex electro/mechanical & Optical systems.
Work with outside suppliers, PCBA Designers, Board Fabrication Houses, PCBA assemblers, Cable manufacturers and contract manufacturers for development, qualification, release and introduction of new electrical and electronic systems, boards, components and cables into production.
Collect/ review data and communicate both status and recommendation on technical issues by preparing technical reports and presentations.
Initiate, execute & review product changes via OptiMedica?s ECO process.
Provide support for incoming component & PCBA inspection, tracking of component issues, and supplier interfacing to assure product quality.
Provide continuous support for manufacturing and resolve complex electrical/electronic manufacturing issues.
Develop assembly instructions, test methods, PCBA test procedures and create test and qualification reports for new product introduction.
Resolve non-conforming material issues/in-process failures and represent department through the Material Review Board (MRB) process.
Generate IQ and OQ test protocols/reports for equipment and fixtures.
Engage with New Product Introduction teams and Contract Manufacturers during design and development to influence Design for Manufacturability (DFM) and Design for
Must have a minimum of (8) years experience in a manufacturing engineering role in a medical device company or a similarly highly regulated industry.
Highly developed problem solving, communication and teamwork skills.
Solid background in analog and digital circuit design.
2-5 years of experience developing Manufacturing automated test, measurement and data acquisition systems using LabVIEW.
Experience with National Instruments hardware (especially FPGA); experience with a variety of programmable instruments a plus.
2-5 years of experience working with product development team to transfer new products into production for commercial sale. Key participation in the test and integration of successfully shipped medical products is strongly preferred.
Knowledge, experience and understanding of electrical & electronic drawing standards, schematics and Gerber files. Experience with ORCAD Schematic Capture and Board Layout Design strongly preferred.
Must be well organized and enjoy working in a dynamic environment.
Strong written and verbal communication skills.
Familiar with Electrical Safety & EMC/EMI Qualification Testing for Medical Equipment.
Experience with, and full understanding of, Design For Manufacture and Assembly (DFMA) principles and practices.
IPC610 Certification desired.
Strong knowledge of the FDA and ISO Quality System Regulations (knowledge from other highly-regulated industries will be
Bachelor?s degree in electronic/electrical engineering.
||3130 Coronado Drive |
Santa Clara, CA 95054
THIS JOB HAS EXPIRED