Frederick Fox

Manufacturing EngineerPosition OverviewOur client is seeking an experienced Manufacturing Engineer to design, implement, validate, and continuously improve manufacturing processes for medical device products. The Manufacturing Engineer will work collaboratively with Engineering, Quality Assurance, Research and Development, and Production teams to ensure manufacturing processes are safe, efficient, repeatable, compliant, and capable of consistently producing high-quality products.This role will have responsibility for developing and maintaining manufacturing documentation, designing production processes and equipment, supporting process validation, troubleshooting manufacturing issues, and driving continuous improvement across safety, quality, productivity, lead time, and cost.The ideal candidate has strong medical device manufacturing experience, a solid understanding of regulated manufacturing environments, and the ability to work independently while collaborating effectively across functions.Key ResponsibilitiesManufacturing Process Development<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Design, develop, implement, and maintain manufacturing processes for medical device products.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop Process Failure Mode and Effects Analyses (PFMEAs), Process Flow Diagrams, manufacturing cell and line layouts, process routers, Standard Operating Procedures (SOPs), and Work Instructions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Design manufacturing processes with a focus on safety, quality, productivity, cost, and repeatability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Specify and implement manufacturing equipment, tooling, fixtures, and production systems.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop and optimize automated, semi-automated, and manual assembly and test processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure manufacturing processes are appropriately documented and controlled throughout the product lifecycle.</li>
</ul>Equipment &amp; Process Validation<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop, execute, and document equipment qualification and process validation activities.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Perform and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop validation protocols, reports, and supporting documentation in accordance with applicable quality requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure manufacturing equipment and tooling are properly documented and maintained under appropriate calibration and preventive maintenance controls.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify opportunities to automate or improve production equipment and tooling.</li>
</ul>Quality &amp; Regulatory Compliance<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Participate in FMEA activities to identify potential process failures, risks, and opportunities for improvement.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Partner with Quality Assurance to ensure manufacturing processes comply with applicable quality system requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Collaborate with Quality Assurance and Research and Development to maintain an effective internal Quality System.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support compliance with FDA GMP, Quality System Regulation (QSR), ISO 13485, and other applicable regulatory and quality requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify root causes of manufacturing process nonconformities and develop appropriate corrective and preventive actions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Utilize NCMR and CAPA processes to investigate issues, implement corrective actions, and prevent recurrence.</li>
</ul>Production Support<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support pilot production and product introduction activities.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Provide technical support to Production throughout the manufacturing process.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure production operators are appropriately trained on manufacturing processes, equipment, and work instructions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Monitor production activities to ensure schedules are met and required documentation is complete and accurate.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Work directly with production personnel to identify process issues, inefficiencies, and improvement opportunities.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Troubleshoot manufacturing issues and implement effective technical solutions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Provide engineering support during production ramp-up and ongoing manufacturing operations.</li>
</ul>Continuous Improvement<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Continuously improve manufacturing processes to enhance safety, quality, lead time, productivity, and cost.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Analyze manufacturing data and process performance to identify opportunities for improvement.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Implement lean and process improvement methodologies where appropriate.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Evaluate manufacturing processes for opportunities to reduce waste, improve throughput, and increase process reliability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Partner with cross-functional teams to implement sustainable process improvements.</li>
</ul>Cross-Functional Collaboration<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Work closely with Design Engineers to ensure products are designed for manufacturability, reliability, quality, and cost effectiveness.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Collaborate with Research and Development during product development, pilot production, and transfer activities.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Partner with Quality Assurance to resolve process issues and maintain compliance.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Work with Production teams to ensure manufacturing processes are practical, efficient, and consistently executed.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Communicate technical information clearly to engineering, quality, production, and other stakeholders.</li>
</ul>Environment &amp; Work StyleThis role operates in a regulated medical device manufacturing environment and requires frequent collaboration with Engineering, Quality, R&amp;D, and Production teams.The successful candidate should be comfortable balancing hands-on manufacturing support with engineering analysis, documentation, validation, and process improvement activities. The role requires someone who can work independently, manage multiple priorities, and take ownership of projects with minimal supervision.Essential Qualifications<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">5–8 years of medical device manufacturing experience.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, or a related engineering discipline.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong knowledge of manufacturing process development and production support.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience designing and developing electro-mechanical components, assemblies, tooling, or manufacturing equipment.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with 3D solid modeling, including SolidWorks, AutoCAD, Pro/Engineer, or comparable platforms.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Working knowledge of FDA GMP, QSR, and ISO 13485 requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with process validation and equipment qualification, including IQ, OQ, and PQ.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience developing manufacturing documentation, including process flows, routers, work instructions, and SOPs.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Proficiency with Microsoft Office.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong analytical, problem-solving, and troubleshooting skills.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ability to work effectively both independently and as part of a cross-functional team.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Demonstrated ability to work with minimal supervision and take ownership of assigned responsibilities.</li>
</ul>Preferred Qualifications<ul style="margin:0px;padding-left:40px;">
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with SolidWorks strongly preferred.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience developing automated and semi-automated manufacturing equipment.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with medical device assembly and test processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with process FMEA and risk management.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with NCMR and CAPA investigations.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience supporting new product introduction and pilot production.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Familiarity with lean manufacturing and continuous improvement methodologies.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience working within a formal regulated Quality Management System.</li>
</ul>

Manufacturing Engineer

Position Overview

Our client is seeking an experienced Manufacturing Engineer to
design, implement, validate, and continuously improve
manufacturing processes for medical device products. The
Manufacturing Engineer will work collaboratively with
Engineering, Quality Assurance, Research and Development, and
Production teams to ensure manufacturing processes are safe,
efficient, repeatable, compliant, and capable of consistently
producing high-quality products.

This role will have responsibility for developing and maintaining
manufacturing documentation, designing production processes and
equipment, supporting process validation, troubleshooting
manufacturing issues, and driving continuous improvement across
safety, quality, productivity, lead time, and cost.

The ideal candidate has strong medical device manufacturing
experience, a solid understanding of regulated manufacturing
environments, and the ability to work independently while
collaborating effectively across functions.

Key Responsibilities

Manufacturing Process Development

* Design, develop, implement, and maintain manufacturing
processes for medical device products.
* Develop Process Failure Mode and Effects Analyses (PFMEAs),
Process Flow Diagrams, manufacturing cell and line layouts,
process routers, Standard Operating Procedures (SOPs), and Work
Instructions.
* Design manufacturing processes with a focus on safety, quality,
productivity, cost, and repeatability.
* Specify and implement manufacturing equipment, tooling,
fixtures, and production systems.
* Develop and optimize automated, semi-automated, and manual
assembly and test processes.
* Ensure manufacturing processes are appropriately documented and
controlled throughout the product lifecycle.
Equipment & Process Validation

* Develop, execute, and document equipment qualification and
process validation activities.
* Perform and support Installation Qualification (IQ),
Operational Qualification (OQ), and Performance Qualification
(PQ).
* Develop validation protocols, reports, and supporting
documentation in accordance with applicable quality requirements.
* Ensure manufacturing equipment and tooling are properly
documented and maintained under appropriate calibration and
preventive maintenance controls.
* Identify opportunities to automate or improve production
equipment and tooling.
Quality & Regulatory Compliance

* Participate in FMEA activities to identify potential process
failures, risks, and opportunities for improvement.
* Partner with Quality Assurance to ensure manufacturing
processes comply with applicable quality system requirements.
* Collaborate with Quality Assurance and Research and Development
to maintain an effective internal Quality System.
* Support compliance with FDA GMP, Quality System Regulation
(QSR), ISO 13485, and other applicable regulatory and quality
requirements.
* Identify root causes of manufacturing process nonconformities
and develop appropriate corrective and preventive actions.
* Utilize NCMR and CAPA processes to investigate issues,
implement corrective actions, and prevent recurrence.
Production Support

* Support pilot production and product introduction activities.
* Provide technical support to Production throughout the
manufacturing process.
* Ensure production operators are appropriately trained on
manufacturing processes, equipment, and work instructions.
* Monitor production activities to ensure schedules are met and
required documentation is complete and accurate.
* Work directly with production personnel to identify process
issues, inefficiencies, and improvement opportunities.
* Troubleshoot manufacturing issues and implement effective
technical solutions.
* Provide engineering support during production ramp-up and
ongoing manufacturing operations.
Continuous Improvement

* Continuously improve manufacturing processes to enhance safety,
quality, lead time, productivity, and cost.
* Analyze manufacturing data and process performance to identify
opportunities for improvement.
* Implement lean and process improvement methodologies where
appropriate.
* Evaluate manufacturing processes for opportunities to reduce
waste, improve throughput, and increase process reliability.
* Partner with cross-functional teams to implement sustainable
process improvements.
Cross-Functional Collaboration

* Work closely with Design Engineers to ensure products are
designed for manufacturability, reliability, quality, and cost
effectiveness.
* Collaborate with Research and Development during product
development, pilot production, and transfer activities.
* Partner with Quality Assurance to resolve process issues and
maintain compliance.
* Work with Production teams to ensure manufacturing processes
are practical, efficient, and consistently executed.
* Communicate technical information clearly to engineering,
quality, production, and other stakeholders.
Environment & Work Style

This role operates in a regulated medical device manufacturing
environment and requires frequent collaboration with Engineering,
Quality, R&D, and Production teams.

The successful candidate should be comfortable balancing hands-on
manufacturing support with engineering analysis, documentation,
validation, and process improvement activities. The role requires
someone who can work independently, manage multiple priorities,
and take ownership of projects with minimal supervision.

Essential Qualifications

* 5–8 years of medical device manufacturing experience.
* Bachelor's degree in Mechanical Engineering, Mechanical
Engineering Technology, or a related engineering discipline.
* Strong knowledge of manufacturing process development and
production support.
* Experience designing and developing electro-mechanical
components, assemblies, tooling, or manufacturing equipment.
* Experience with 3D solid modeling, including SolidWorks,
AutoCAD, Pro/Engineer, or comparable platforms.
* Working knowledge of FDA GMP, QSR, and ISO 13485 requirements.
* Experience with process validation and equipment qualification,
including IQ, OQ, and PQ.
* Experience developing manufacturing documentation, including
process flows, routers, work instructions, and SOPs.
* Proficiency with Microsoft Office.
* Strong analytical, problem-solving, and troubleshooting skills.
* Ability to work effectively both independently and as part of a
cross-functional team.
* Demonstrated ability to work with minimal supervision and take
ownership of assigned responsibilities.
Preferred Qualifications

* Experience with SolidWorks strongly preferred.
* Experience developing automated and semi-automated
manufacturing equipment.
* Experience with medical device assembly and test processes.
* Experience with process FMEA and risk management.
* Experience with NCMR and CAPA investigations.
* Experience supporting new product introduction and pilot
production.
* Familiarity with lean manufacturing and continuous improvement
methodologies.
* Experience working within a formal regulated Quality Management
System.

Manufacturing Engineer

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