Frederick Fox

Production ManagerPosition OverviewThe Production Manager is responsible for leading manufacturing operations for complex, highly regulated products within a medical device manufacturing environment. This role provides overall production leadership with a focus on safety, quality, delivery, cost, continuous improvement, and team development.The Production Manager will oversee adherence to established manufacturing processes, production planning and execution, process improvement, capacity and scalability, and the development of a high-performing manufacturing team. This position works closely with Quality, Supply Chain, Planning, Engineering, and other cross-functional teams to ensure production requirements are met while maintaining the highest standards of quality and regulatory compliance.The ideal candidate brings extensive experience in complex manufacturing environments, strong knowledge of medical device quality systems, Lean manufacturing expertise, and a proven ability to lead teams and drive operational performance.Key ResponsibilitiesProduction Leadership &amp; Operational Excellence<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;">Provide overall leadership for assigned manufacturing operations and drive performance against established goals for safety, quality, delivery, and cost.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure production activities consistently meet customer demand, quality requirements, labor standards, and delivery commitments.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Direct the planning, scheduling, and execution of manufacturing activities in collaboration with Planning, Supply Chain, Quality, and other Operations functions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure manufacturing processes are executed in accordance with approved procedures, work instructions, specifications, and quality requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Monitor production performance and identify opportunities to improve efficiency, capacity, throughput, and overall operational performance.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Communicate key business, operational, and customer priorities to production employees and ensure alignment across the team.</li>
</ul>Process Improvement &amp; Lean Manufacturing<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;">Lead continuous improvement initiatives focused on process efficiency, product quality, cost reduction, and manufacturing scalability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify and implement opportunities to improve manufacturing methods, workflows, productivity, and process capability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Apply Lean manufacturing principles and problem-solving methodologies to improve production performance and product manufacturability.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Establish, monitor, and maintain visual performance metrics to provide clear visibility into operational results.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Promote a sustainable culture of continuous improvement and accountability throughout the manufacturing organization.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Lead root cause analysis and corrective action efforts related to production performance, quality, and process issues.</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;">Ensure production activities comply with applicable medical device quality systems, regulatory requirements, and internal procedures.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Promote a culture of quality and ensure employees understand and follow established policies, procedures, and work instructions.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Partner with Quality and other cross-functional teams to address manufacturing and quality issues in a timely and effective manner.</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 requirements, ISO 13485 standards, and other relevant regulatory requirements.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Maintain a strong focus on product quality, process control, documentation, and customer requirements.</li>
</ul>Team Leadership &amp; Talent 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;">Lead, mentor, and develop production personnel to build a high-performing and accountable team.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Participate in the selection, hiring, onboarding, training, and development of employees.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Establish clear expectations, goals, and performance standards for assigned team members.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Provide ongoing coaching, feedback, supervision, and performance management.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support employees in developing their skills and pursuing opportunities for professional growth and advancement.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Structure staffing and organizational resources to effectively support production requirements and business objectives.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Foster a collaborative, respectful, and results-oriented work environment.</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 closely with Engineering, Quality, Supply Chain, Planning, Maintenance, and other functional teams to support production objectives.</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 resolve production constraints, quality issues, material challenges, and process inefficiencies.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Communicate production status, risks, opportunities, and resource requirements to appropriate stakeholders.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support customer-facing activities and communicate effectively with strategic customers when required.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Ensure production priorities remain aligned with broader business and customer objectives.</li>
</ul>Manufacturing Scalability &amp; Capacity<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;">Evaluate production capacity, staffing, equipment, processes, and resources to support current and future demand.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Develop and implement strategies to scale complex manufacturing processes effectively.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Identify potential production constraints and develop proactive solutions to support business growth.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Support new product introduction, production ramp-up, and process transition activities as needed.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Continuously evaluate manufacturing capabilities and recommend improvements to support long-term operational scalability.</li>
</ul>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 Operations Management, Manufacturing, Engineering, Business, or a related field preferred; equivalent relevant experience may be considered in lieu of a formal degree.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">10+ years of progressive experience in complex manufacturing operations preferred.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Minimum of 5 years of experience in a medical device manufacturing environment; 10 years preferred.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience working within FDA-regulated and ISO 13485 quality systems.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with complex electromechanical products or similarly sophisticated manufacturing processes strongly preferred.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Cleanroom manufacturing experience preferred.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Experience with implantable medical devices or other highly regulated medical products is beneficial.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Proven experience leading manufacturing teams and managing production operations.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong understanding of Lean manufacturing principles, continuous improvement, root cause analysis, and structured problem-solving methodologies.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Knowledge of production planning, inventory control, labor standards, manufacturing metrics, and standard cost systems.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong analytical and problem-solving skills with the ability to identify issues, evaluate alternatives, and implement effective solutions.</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, including the ability to communicate effectively with employees, leadership, and strategic customers.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong interpersonal, leadership, coaching, and team-building skills.</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 in a fast-paced, highly regulated manufacturing environment.</li>
<li style="line-height:1.2;font-family:Arial;font-size:14px;color:rgb(0, 0, 0);margin:0px;">Strong attention to detail and commitment to safety, quality, compliance, and operational excellence.</li>
</ul>

Production Manager

Position Overview

The Production Manager is responsible for leading manufacturing
operations for complex, highly regulated products within a
medical device manufacturing environment. This role provides
overall production leadership with a focus on safety, quality,
delivery, cost, continuous improvement, and team development.

The Production Manager will oversee adherence to established
manufacturing processes, production planning and execution,
process improvement, capacity and scalability, and the
development of a high-performing manufacturing team. This
position works closely with Quality, Supply Chain, Planning,
Engineering, and other cross-functional teams to ensure
production requirements are met while maintaining the highest
standards of quality and regulatory compliance.

The ideal candidate brings extensive experience in complex
manufacturing environments, strong knowledge of medical device
quality systems, Lean manufacturing expertise, and a proven
ability to lead teams and drive operational performance.

Key Responsibilities

Production Leadership & Operational Excellence

* Provide overall leadership for assigned manufacturing
operations and drive performance against established goals for
safety, quality, delivery, and cost.
* Ensure production activities consistently meet customer demand,
quality requirements, labor standards, and delivery commitments.
* Direct the planning, scheduling, and execution of manufacturing
activities in collaboration with Planning, Supply Chain, Quality,
and other Operations functions.
* Ensure manufacturing processes are executed in accordance with
approved procedures, work instructions, specifications, and
quality requirements.
* Monitor production performance and identify opportunities to
improve efficiency, capacity, throughput, and overall operational
performance.
* Communicate key business, operational, and customer priorities
to production employees and ensure alignment across the team.
Process Improvement & Lean Manufacturing

* Lead continuous improvement initiatives focused on process
efficiency, product quality, cost reduction, and manufacturing
scalability.
* Identify and implement opportunities to improve manufacturing
methods, workflows, productivity, and process capability.
* Apply Lean manufacturing principles and problem-solving
methodologies to improve production performance and product
manufacturability.
* Establish, monitor, and maintain visual performance metrics to
provide clear visibility into operational results.
* Promote a sustainable culture of continuous improvement and
accountability throughout the manufacturing organization.
* Lead root cause analysis and corrective action efforts related
to production performance, quality, and process issues.
Quality & Regulatory Compliance

* Ensure production activities comply with applicable medical
device quality systems, regulatory requirements, and internal
procedures.
* Promote a culture of quality and ensure employees understand
and follow established policies, procedures, and work
instructions.
* Partner with Quality and other cross-functional teams to
address manufacturing and quality issues in a timely and
effective manner.
* Support compliance with applicable FDA requirements, ISO 13485
standards, and other relevant regulatory requirements.
* Maintain a strong focus on product quality, process control,
documentation, and customer requirements.
Team Leadership & Talent Development

* Lead, mentor, and develop production personnel to build a
high-performing and accountable team.
* Participate in the selection, hiring, onboarding, training, and
development of employees.
* Establish clear expectations, goals, and performance standards
for assigned team members.
* Provide ongoing coaching, feedback, supervision, and
performance management.
* Support employees in developing their skills and pursuing
opportunities for professional growth and advancement.
* Structure staffing and organizational resources to effectively
support production requirements and business objectives.
* Foster a collaborative, respectful, and results-oriented work
environment.
Cross-Functional Collaboration

* Collaborate closely with Engineering, Quality, Supply Chain,
Planning, Maintenance, and other functional teams to support
production objectives.
* Partner with cross-functional teams to resolve production
constraints, quality issues, material challenges, and process
inefficiencies.
* Communicate production status, risks, opportunities, and
resource requirements to appropriate stakeholders.
* Support customer-facing activities and communicate effectively
with strategic customers when required.
* Ensure production priorities remain aligned with broader
business and customer objectives.
Manufacturing Scalability & Capacity

* Evaluate production capacity, staffing, equipment, processes,
and resources to support current and future demand.
* Develop and implement strategies to scale complex manufacturing
processes effectively.
* Identify potential production constraints and develop proactive
solutions to support business growth.
* Support new product introduction, production ramp-up, and
process transition activities as needed.
* Continuously evaluate manufacturing capabilities and recommend
improvements to support long-term operational scalability.
Qualifications

* Bachelor’s degree in Operations Management, Manufacturing,
Engineering, Business, or a related field preferred; equivalent
relevant experience may be considered in lieu of a formal degree.
* 10+ years of progressive experience in complex manufacturing
operations preferred.
* Minimum of 5 years of experience in a medical device
manufacturing environment; 10 years preferred.
* Experience working within FDA-regulated and ISO 13485 quality
systems.
* Experience with complex electromechanical products or similarly
sophisticated manufacturing processes strongly preferred.
* Cleanroom manufacturing experience preferred.
* Experience with implantable medical devices or other highly
regulated medical products is beneficial.
* Proven experience leading manufacturing teams and managing
production operations.
* Strong understanding of Lean manufacturing principles,
continuous improvement, root cause analysis, and structured
problem-solving methodologies.
* Knowledge of production planning, inventory control, labor
standards, manufacturing metrics, and standard cost systems.
* Strong analytical and problem-solving skills with the ability
to identify issues, evaluate alternatives, and implement
effective solutions.
* Excellent written and verbal communication skills, including
the ability to communicate effectively with employees,
leadership, and strategic customers.
* Strong interpersonal, leadership, coaching, and team-building
skills.
* Ability to manage multiple priorities in a fast-paced, highly
regulated manufacturing environment.
* Strong attention to detail and commitment to safety, quality,
compliance, and operational excellence.

Production Manager

About the role

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