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Precision Optics Corporation · 1 day ago

Senior Manufacturing Engineer

Gardner, MA

Full-time

Onsite

Senior Level, Lead/Staff

$110K/yr - $130K/yr

8+ years exp

Precision Optics Corporation is seeking a Senior Manufacturing Engineer who will be a key contributor to the design and development of manufacturing processes, tools, and procedures. The role involves providing engineering support for New Product Introduction (NPI) and leading continuous improvement activities to ensure high-quality and efficient manufacturing processes.

AerospaceHealth CareManufacturingMedical

No H1B

U.S. Citizen Only

Responsibilities

Designs, develops and documents manufacturing systems, processes and tools for new products, product & process changes, to meet targets for quality, efficiency, and reliability

Creates and maintains manufacturing plans, procedures, process FMEAs, flowcharts, workflows, layouts, routings, time standards, and associated tools/equipment, fixtures, and material handling systems

Provides direct manufacturing engineering support for product characterization, and product builds at prototype, verification, validation, and commercial manufacturing stages, to meet ISO 13485 requirements & FDA regulations

Interfaces with design engineers during new product development or product enhancement projects to develop DMR documentation and assure design for manufacturability, assembly & test

Identifies/leads continuous improvement projects using Lean methodologies to improve manufacturing/business systems, processes, and tools to improve quality, eliminate waste, and reduce cost; fosters a Lean culture

Maintains manufacturing master data in ERP systems; initiates/approves engineering change requests/orders

Drives and supports the implementation of effective manufacturing process controls, statistical measurements, and metrics to assure products & processes meet quality and business objectives

Performs capacity and utilization studies, time and motion studies, labor/cycle time analysis, and line balancing

Represents manufacturing in all internal quality processes including MRB & non-conformance handling, complaint reviews, and internal and external quality audits; drives resolution of quality issues using CAPA systems

Functions as the lead technical liaison with suppliers and contract manufacturers; provides technical guidance to suppliers regarding compliance with engineering drawings and other technical requirements/specifications

Partners with quality engineering and suppliers to ensure corrective action or problem resolution to meet quality, cost and delivery targets, and support supplier performance management

Leads large scale projects related to facility moves, re-layouts, Lean training, and Lean transformation projects

Perform miscellaneous duties and projects as assigned and required

Qualification

Manufacturing engineering experienceLean Six Sigma certificationFMEA creationProcess verificationValidationERP/PLM proficiencyStatistical analysisSolidWorks proficiencyProject management skillsProblem-solving skillsCommunication skills

Required

8+ years of related manufacturing/industrial engineering work experience required, including 3+ years of experience with medical devices in FDA QSR & ISO13485 regulated environment

Experience with manufacturing of complex electro-mechanical products required

Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and transferring new products into manufacturing

Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge with SolidWorks, Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems

Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke

Bachelor's degree in manufacturing, industrial engineering, or a related technical field

Preferred

Some quality engineering experience and exposure to opto-mechanical/electrical product manufacturing preferred

Lean and/or Six Sigma Black Belt certification highly preferred, with demonstrated success in rolling out Lean methods and tools to improve quality and efficiency in manufacturing environments

Demonstrated experience in data collection and statistical analysis, proficiency with Minitab or other statistical software highly preferred

Master's degree preferred