Frederick Fox

Mechanical Engineer – Medical DevicesPosition OverviewWe are seeking an experienced Mechanical Engineer to support the design, development, testing, and optimization of innovative medical devices. This role will work closely with Engineering, Quality, Operations, Supply Chain, and other cross-functional teams throughout the product development lifecycle.The Mechanical Engineer will be involved in mechanical design, materials and component selection, prototype development, testing, validation, and technical documentation. The ideal candidate has strong hands-on design experience, excellent problem-solving skills, and a solid understanding of medical device development and regulatory requirements.Key ResponsibilitiesMechanical Design &amp; Product 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 and develop mechanical components, assemblies, and medical devices.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Create detailed 3D models, engineering drawings, specifications, and design documentation.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Evaluate design concepts for functionality, reliability, manufacturability, safety, and cost.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop and refine components, subsystems, and complete assemblies.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Translate customer and product requirements into practical engineering designs and project milestones.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support new product development from concept through production.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify and resolve mechanical design challenges throughout the development process.</li>
</ul>Testing &amp; 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 and execute product characterization and environmental testing.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Create test plans, protocols, procedures, and acceptance criteria.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Participate in prototype testing and product evaluations.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Analyze test results and prepare comprehensive technical reports.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify design risks and develop solutions to improve product performance and reliability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support design verification and validation activities.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure testing is completed accurately and within established project timelines.</li>
</ul>Manufacturing &amp; Supplier 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 with suppliers to identify and qualify materials, components, tooling, and manufacturing processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support supplier selection and technical evaluations.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Collaborate with Operations and Manufacturing teams to ensure designs are practical and scalable for production.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Apply design-for-manufacturability principles throughout product development.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Work with manufacturing partners on processes such as injection molding, metal forming, welding, and plastic/metal joining.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support development of automated and semi-automated manufacturing processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Evaluate opportunities to improve manufacturing efficiency, product quality, and cost.</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;">Work closely with Quality Assurance to ensure products meet design specifications and applicable requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Prepare and review technical documentation supporting product feasibility, development, testing, and manufacturing.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support compliance with applicable FDA Quality System Regulation (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;">Apply design control principles throughout the product development process.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Participate in design reviews, risk assessments, and corrective actions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify and mitigate risks related to product safety, reliability, functionality, cost, and manufacturability.</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;">Collaborate with Engineering, Quality, Operations, Supply Chain, and management throughout product development.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Participate in cross-functional project meetings and provide technical recommendations.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Communicate project status, technical challenges, and potential solutions to stakeholders.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Coordinate engineering activities to meet project milestones and deadlines.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Help ensure engineering projects align with organizational objectives and product requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Provide technical support to other departments as needed.</li>
</ul>Required 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;">Bachelor's degree in Mechanical Engineering 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;">
5+ years of mechanical design engineering experience.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong proficiency with SolidWorks or similar 3D CAD software.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience developing new products, technologies, and manufacturing processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with injection molding, metal forming, welding, and other joining methods.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with design for manufacturing and/or design for automation.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Understanding of mechanical design principles, materials, tolerances, and manufacturing processes.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Working knowledge of FDA QSR and ISO 13485 Design Controls.</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 project management skills.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Excellent written and verbal communication skills.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Proficiency with Microsoft Office and project management tools such as Microsoft Project.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ability to work independently with minimal supervision.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ability to manage multiple priorities and consistently meet project deadlines.</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;">Master's degree in Engineering or a related technical discipline.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">
7+ years of medical device engineering experience.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience working in an FDA-regulated and ISO 13485-compliant design and manufacturing environment.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">SolidWorks certification or advanced SolidWorks expertise.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with electro-mechanical instrumentation.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with robotics, automation, or automated manufacturing systems.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with medical device testing, validation, and design verification.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with risk management and product development documentation</li>
</ul>

Mechanical Engineer – Medical Devices

Position Overview

We are seeking an experienced Mechanical Engineer to support the
design, development, testing, and optimization of innovative
medical devices. This role will work closely with Engineering,
Quality, Operations, Supply Chain, and other cross-functional
teams throughout the product development lifecycle.

The Mechanical Engineer will be involved in mechanical design,
materials and component selection, prototype development,
testing, validation, and technical documentation. The ideal
candidate has strong hands-on design experience, excellent
problem-solving skills, and a solid understanding of medical
device development and regulatory requirements.

Key Responsibilities

Mechanical Design & Product Development

* Design and develop mechanical components, assemblies, and
medical devices.
* Create detailed 3D models, engineering drawings,
specifications, and design documentation.
* Evaluate design concepts for functionality, reliability,
manufacturability, safety, and cost.
* Develop and refine components, subsystems, and complete
assemblies.
* Translate customer and product requirements into practical
engineering designs and project milestones.
* Support new product development from concept through
production.
* Identify and resolve mechanical design challenges throughout
the development process.
Testing & Validation

* Develop and execute product characterization and environmental
testing.
* Create test plans, protocols, procedures, and acceptance
criteria.
* Participate in prototype testing and product evaluations.
* Analyze test results and prepare comprehensive technical
reports.
* Identify design risks and develop solutions to improve product
performance and reliability.
* Support design verification and validation activities.
* Ensure testing is completed accurately and within established
project timelines.
Manufacturing & Supplier Collaboration

* Work with suppliers to identify and qualify materials,
components, tooling, and manufacturing processes.
* Support supplier selection and technical evaluations.
* Collaborate with Operations and Manufacturing teams to ensure
designs are practical and scalable for production.
* Apply design-for-manufacturability principles throughout
product development.
* Work with manufacturing partners on processes such as injection
molding, metal forming, welding, and plastic/metal joining.
* Support development of automated and semi-automated
manufacturing processes.
* Evaluate opportunities to improve manufacturing efficiency,
product quality, and cost.
Quality & Regulatory Compliance

* Work closely with Quality Assurance to ensure products meet
design specifications and applicable requirements.
* Prepare and review technical documentation supporting product
feasibility, development, testing, and manufacturing.
* Support compliance with applicable FDA Quality System
Regulation (QSR) and ISO 13485 requirements.
* Apply design control principles throughout the product
development process.
* Participate in design reviews, risk assessments, and corrective
actions.
* Identify and mitigate risks related to product safety,
reliability, functionality, cost, and manufacturability.
Cross-Functional Collaboration

* Collaborate with Engineering, Quality, Operations, Supply
Chain, and management throughout product development.
* Participate in cross-functional project meetings and provide
technical recommendations.
* Communicate project status, technical challenges, and potential
solutions to stakeholders.
* Coordinate engineering activities to meet project milestones
and deadlines.
* Help ensure engineering projects align with organizational
objectives and product requirements.
* Provide technical support to other departments as needed.
Required Qualifications

* Bachelor's degree in Mechanical Engineering or a related
engineering discipline.
* 5+ years of mechanical design engineering experience.
* Strong proficiency with SolidWorks or similar 3D CAD software.
* Experience developing new products, technologies, and
manufacturing processes.
* Experience with injection molding, metal forming, welding, and
other joining methods.
* Experience with design for manufacturing and/or design for
automation.
* Understanding of mechanical design principles, materials,
tolerances, and manufacturing processes.
* Working knowledge of FDA QSR and ISO 13485 Design Controls.
* Strong analytical, problem-solving, and project management
skills.
* Excellent written and verbal communication skills.
* Proficiency with Microsoft Office and project management tools
such as Microsoft Project.
* Ability to work independently with minimal supervision.
* Ability to manage multiple priorities and consistently meet
project deadlines.
Preferred Qualifications

* Master's degree in Engineering or a related technical
discipline.
* 7+ years of medical device engineering experience.
* Experience working in an FDA-regulated and ISO 13485-compliant
design and manufacturing environment.
* SolidWorks certification or advanced SolidWorks expertise.
* Experience with electro-mechanical instrumentation.
* Experience with robotics, automation, or automated
manufacturing systems.
* Experience with medical device testing, validation, and design
verification.
* Experience with risk management and product development
documentation

Mechanical Engineer - 3 Openings

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