Sr. Manufacturing Engineer

ZipRecruiter; Gardner (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company is seeking a Senior Manufacturing Engineer to lead the design and development of manufacturing processes and ensure compliance with ISO and FDA regulations. This role requires extensive experience in complex electro-mechanical product manufacturing, strong problem-solving skills, and the ability to drive continuous improvement initiatives. The position offers significant responsibilities in enhancing quality and efficiency of production systems while supporting new product introductions.

Qualifications

• 8+ years of related manufacturing/industrial engineering experience.
• Experience with medical devices in FDA QSR & ISO13485 environment.
• Lean and/or Six Sigma Black Belt certification.

Responsibilities

• Designs and develops manufacturing systems and tools to meet quality and efficiency targets.
• Leads continuous improvement projects using Lean methodologies.
• Provides engineering support for product characterization and builds.

Skills

Lean manufacturing

Problem-solving

Data analysis

Education

Bachelor’s degree in manufacturing, industrial engineering, or related field

Tools

SolidWorks

Minitab

Microsoft Office 365 Suite

Job description

Job DescriptionJob DescriptionDescription:

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:

• 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 .
• 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 , 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 .
• 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 . Master's degree .

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

This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant’s capacity to serve in compliance with U.S. export controls.