Manufacturing Engineer - Urgent Need

MillenniumSoft Inc; San Jose (CA); On-site; USD 28,000 - 41,000; Full time

Job summary

Medical Devices Company seeks a Senior Manufacturing Engineer in San Jose to lead multiple high-impact projects, drive engineering changes, and mentor teams in a fast-paced environment.

The role requires hands-on electromechanical expertise, robust project management, and deep knowledge of manufacturing processes, SOPs, and regulatory standards. Travel may be required.

Qualifications

• BS degree in ME, EE, IE, Physics, or equivalents.
• At least 4 years of experience in a high-tech manufacturing environment.
• Experience sustaining and troubleshooting electro-mechanical devices/equipment.
• Proficient in SolidWorks (CAD), MS Office (Word, Excel, Power Point, Project, Visio), Adobe.
• Familiar with ERP SAP, Agile or the like.
• Excellent written and verbal communication skills; good interpersonal skills.
• Able to read engineering drawings, Bills of Materials, and operational procedures.
• Experience writing and reviewing Engineering Change Orders.
• Strong project management and cross-functional leadership.
• Experience developing manufacturing processes, writing procedures, and training assembly personnel.
• ISO 9001 and 13485 familiarity.
• Willingness to travel

Responsibilities

• Initiate, plan and author engineering change orders to product design, BOMs, manufacturing/test/packaging procedures, process routings, tooling, compliance, suppliers in a controlled environment.
• Follow proper document formats, material and description nomenclature, and correct SAP data types per company standards.
• Coordinate with various functions for change review and impact analysis, ensuring cross-functional requirements are identified and understood.
• Lead cross functional project teams to optimize product design, qualify replacement components, improve manufacturing efficiency, quality, and customer satisfaction.
• Capable of solving and determining root cause of difficult technical issues encountered during assembly and test of production assemblies.
• Implement effective solutions to resolve mechanical, optical, electrical, and fluidic issues in a timely manner.
• Support the introduction and transfer of new products into manufacturing; review designs and docs for manufacturability.
• Evaluate and qualify new suppliers; interface with Product Development to define manufacturability criteria and procedures; ensure validation in manufacturing before production release.
• Conduct field failure investigations, identify root causes, and participate in corrective and preventive actions.
• Keep abreast of regulatory requirements affecting own area; participate in training on regulatory issues.
• Bring regulatory compliance questions/issues to management.; Perform other related duties and assignments as required

Skills

SolidWorks

Oscilloscope

Engineering Change Orders

Education

BS degree in ME, EE, IE, Physics, or equivalents

Tools

SAP

Agile

PCBAs & Sheet metal experience

Job description

Client: Medical Devices Company

Level Of Experience: Mid-Level or Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Work hours: 8AM - 5PM

Position : Manufacturing Engineer

Location : San Jose, CA

Duration : 12 Months contract

Total Hours/week : 40.00

pay rate-$20-30/hr

1st Shift

Client: Medical Devices Company

Level Of Experience: Mid-Level or Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Work hours: 8AM - 5PM

3 Must Haves On The Resume

• Must be proficient with SolidWorks, Oscilloscope and Engineering Change Orders
• Must be familiar with ERP SAP system, Agile or the like and Electro-Mechanical assemblies - PCBAs & Sheet metal experience and have troubleshooting experience with instrumentation devices.
• Must have Medical/Pharmaceutical industry experience

Job Description

• The Senior 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 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.

Responsibilities

• Initiate, plan and author engineering change orders to product design, product documentation, Bills of Materials, manufacturing/test/packaging procedures, process routings, tooling, compliance (EMC, safety, laser safety, ROHS, UDI etc.), suppliers and other items in a controlled manufacturing environment.
• Follow proper document formats, material and description nomenclature, and correct SAP data types per company standards.
• Coordinate with various functions for change review and impact analysis, ensuring cross-functional requirements are identified and understood for affected items, personnel, and processes.
• Lead cross functional project teams to optimize product design, qualify replacement components, improve manufacturing operational efficiency, product quality, customer satisfaction, and reduce manufacturing costs.
• Capable of solving and determining root cause of difficult technical issues encountered during assembly and test of production assemblies.
• Must be able to implement effective solutions in a timely manner to resolve mechanical, optical, electrical, and fluidic issues.
• Support the introduction and transfer of new products into manufacturing. Review engineering designs and documentation (drawings & specifications) for completeness, clarity, and manufacturability.
• Evaluate and qualify new suppliers. Interface with Product Development to define and implement manufacturability criteria, develop procedures/processes for assembly, PCB's, systems, and sub-systems test procedures including fixtures, during the development process. Ensure designs, documents, and procedures have been validated in manufacturing prior to production release.
• Conduct field failure investigations, identify root causes, and participate in corrective and preventative action efforts.
• Keep abreast of the basic requirements for compliance. Participate as required in training on regulatory issues affecting own area of work.
• Bring regulatory compliance questions/issues to the attention of management.
• Performs other related duties and assignments as required

Qualifications

• BS degree: ME, EE, IE, Physics, or equivalents
• At least 4 years of experience in a high-tech manufacturing environment
• Experience sustaining and troubleshooting electro-mechanical devices/equipment
• Must be proficient in the use of personal computers: SolidWorks (CAD), MS office (Word, Excel, Power Point, Project, Visio), Adobe
• Familiar with Enterprise Resource Planning (ERP) SAP, Agile or the like
• 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 when required

Preferred Skills And Qualifications

• M.S. degree
• Proficiency with some of the following applications: Pro-E, AutoCAD
• 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