Senior Manufacturing Engineer

ZipRecruiter; Gardner (OH); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading company in the medical device sector seeks a Senior Manufacturing Engineer to enhance manufacturing processes and support product development. This role expects strong leadership in process verification and validation while ensuring compliance with FDA regulations. Ideal candidates will have extensive experience in lean manufacturing and a proven track record in the electro-mechanical products industry.

Qualifications

• 8+ years of manufacturing/industrial engineering experience; 3+ years in FDA QSR & ISO13485 environments.
• Experience with complex electro-mechanical product manufacturing.
• Lean and/or Six Sigma Black Belt certification preferred.

Responsibilities

• Design and document manufacturing systems, processes and tools.
• Lead continuous improvement projects using Lean methodologies.
• Ensure compliance with ISO 13485 requirements during product builds.

Skills

Lean manufacturing

Statistical analysis

Problem solving

Project management

Education

Bachelor’s degree in manufacturing or industrial engineering

Master’s degree (preferred)

Tools

Microsoft Office 365 Suite

ERP/PLM systems

SolidWorks

Minitab

Job description

Job DescriptionJob 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 ofassembly & test processes, tools, and inspection methods. Identifies and leads and continuous improvement activitiesand 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.
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 .
? 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.

Other Requirements
Applicants must have US citizenship or US person status.
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