Manager of Manufacturing Engineering

Location: Paramit - Corporate Headquarter
Job Code: 851
# of openings: 1

Description

Paramit is a rapidly growing international medical device contract design and manufacturing company that has been designing and manufacturing high quality medical and life sciences instruments. Headquartered in Morgan Hill, CA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic Manager of Manufacturing Engineering to join us to manage an extremely high functioning team of experienced manufacturing engineers developing processes for PCBA.

 

Essential Duties and Responsibilities:

·         Provide leadership to the team in managing customer expectations in a fast paced electronics manufacturing environment with a bias to act fast with decisiveness

·         Lead and manage a team of 6-8 experienced manufacturing engineers with BOM management and structure, MPI's for PCBA's, and compliance requirements for medical devices for both NPI and production environments

·         Manage Engineering Change Orders (ECO's) and deviations in alignment with customer changes

·         Generate winning proposals through collaboration with cross-functional teams on new opportunities

·         Manage engineering resources to ensure on-time completion of tasks and project deliverables

·         Drive swift action on correction and prevention of defects to reduce DPMO levels and increase first-pass yields

·         Represent Paramit in design reviews with the customer design team and lead the team of engineers to provide DFx ( DFM, DFT, DFA, DFS, DFC, DFQ ) feedback to the customer

·         Collaborate with cross-functional team leaders ( production, purchasing, quoting, sales, and program management ) to provide engineering support in meeting/beating production goals

·         Be a champion and ambassador of quality and risk mitigation as required by ISO 13485:2016 and FDA QSR guidelines

·         Lead pFMEA process and assess process risks, create detailed mitigation plans and monitor effectiveness

·         Develop robust processes and practices to promote quality

·         Lead manufacturing engineering team to be the key quality point of contact for the customer and collaborate with quality engineering team to monitor process yields

·         Participate in CAPA to drive closure across a global scale with measurable results

·         Create detailed project plans which include resources, costing, and key milestones

Qualifications: 
 
Required Education & Experience: 

o    BS with EE or ME background and at least 10 years of hands-on manufacturing engineering experience working with a EMS/CM – MS preferred

o    5 + years of leadership and active management experience of managing 6-8 engineers with Electrical Engineering, Mechanical Engineering, or Industrial Engineering disciplines

o    Hands-on experience with PCBA manufacturing including SMT, Wave Soldering, SPI, AOI, AXI, ICT, Functional test, MPI, and quality plan creation

o    IPC certification is a plus

·         Required Knowledge, Skills & Abilities: 

o    Deep understanding of BOM analysis, scrub and identifying SMD, PTH, Press-fit connectors/components and creating MPIs for manufacturing of PCBAs

o    Familiarity with PCBA document package including gerber package, ODB++ files, DFMA/DFT requirements, schematics, layouts etc.

o    Technical expertise in PCBA processes - SMT, Solder Alloys, Pick and Place, Reflow, Rework, IPC-610, and Test

o    ECR/ECO management, translating customer ECOs and creating effectivity plans for implementation with disposition

o    Understanding and experience working with ISO 13485, 9001 compliance requirements

o    Familiarity with IPC 610 Class III inspection techniques

o    Understanding and experience of complex PCBAs including FPGA, BGA, QFN, CSP package, multi-layer boards with analog and digital circuits, ability to read schematics, review PCB layout files and manage product quality in the NPI ( development ) phase

o    Mechanical Engineering knowledge with respect to box builds that have multiple PCBAs, display, cables, chassis

o    Thorough understanding of complete product development process from concept to production

o    Proven track record of having been part of a product development team and understanding the electrical engineering disciplines of Analog, Digital designs

o    Familiarity with ISO 13485, FDA QSR requirements and ability to provide assistance to the product development team in completing DHF for submission to FDA

o    Ability to create project plans in MS-Project and ability to track projects to achieve timely completion within budget with quality

o    Strong organizational skills and ability to review/update processes/procedures.

o    Proficient in Microsoft Office, including PowerPoint, Excel and Word.

Preferred:

·         FDA QSR understanding

·         Having led or participated in FDA QSIT audits

·         SMT programming, AOI, AXI programming and developing quality plans using automated testers





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