Senior Manufacturing Engineer at Precision Optics Corporation Inc

Gardner, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Dec, 25

Salary

0.0

Posted On

01 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Engineering, Process Development, Lean Methodologies, Continuous Improvement, Quality Assurance, Statistical Analysis, FMEAs, ISO 13485, FDA Regulations, Project Management, Data Collection, Problem Solving, Mechanical Tolerancing, Electro-Mechanical Products, ERP Systems, Six Sigma

Industry

Medical Equipment Manufacturing

Description

Description The Senior Manufacturing Engineer is a key contributor to the design and development of manufacturing processes, tools, and procedures. Provides direct engineering support for New Product Introduction (NPI), development of assembly & test processes, tools, and inspection methods. Identifies and leads and continuous improvement activities and projects. Responsible for manufacturing process verification & validation and employee training effectiveness. Ensures the smooth running of manufacturing processes with the highest possible quality and efficiency. Principal 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. Requirements Training, Skills, Knowledge and/or Experience 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; some quality engineering experience and exposure to opto-mechanical/electrical product manufacturing preferred. Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and transferring new products into manufacturing. 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. Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge with SolidWorks, Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems. Demonstrated experience in data collection and statistical analysis, proficiency with Minitab or other statistical software highly preferred. Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke. Education Requirements Bachelor’s degree in manufacturing, industrial engineering, or a related technical field; master’s degree preferred. Master's degree preferred. Competencies In-depth understanding of lean manufacturing and supply-chain management methods and tools. Strong attention to detail, with excellent analytical, problem-solving, and project management skills. Strong data collection & analysis, problem solving, presentation and communication skills. Adept at summarizing and presenting complex information to non-technical personnel. Ability to learn and utilize new knowledge quickly and effectively, work independently, without appreciable direction. Supervisory Responsibility None. Working Conditions This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Manufacturing & laboratory environments require the use of electrical and mechanical equipment and tools. Physical Effort While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, manufacturing tools, equipment, products, and systems; reach with hands and arms; talk and hear. Work Schedule / Travel In-person, Monday to Friday; occasional travel of 10 to 20%. Other Requirements Applicants must have US citizenship or US person status.

Responsibilities

The Senior Manufacturing Engineer designs and develops manufacturing processes, tools, and procedures while providing engineering support for New Product Introduction. They lead continuous improvement activities and ensure manufacturing processes run smoothly with high quality and efficiency.