Description
Manufacturing Engineer (St. Louis, Missouri)
Our client, which specializes in the design, engineering, prototyping, and manufacturing of high-quality components and assemblies for medical devices and healthcare applications, is currently hiring two Manufacturing Engineers, Direct Hire.
Scope for these roles are to build, test and improve manufacturing processes- ISO13495 knowledge is critical for this role. Client's premier products are precision-braided shafts, catheter assemblies, extrusions, and delivery systems used in minimally invasive procedures across cardiology, neurology, gastroenterology, orthopedics, and surgery. Operating within FDA-registered and ISO 13485-certified environments, they offer rapid prototyping, process engineering, and quality-controlled manufacturing to ensure compliance and support innovation in critical healthcare technologies. Experience with medical devices, plastic extrusions or similar polymer compounds and materials, which can be used in the production of braided medical catheters is critical.
Summary- Manufacturing Engineers will support high-precision manufacturing operations, including braided endoscopy parts manufacturing, extrusion processes, and secondary operations. The Manufacturing Engineer is responsible for identifying, implementing, reviewing, and continuously improving manufacturing processes, procedures, equipment, and tooling used in the production of medical device components. This role supports high-precision manufacturing operations, including braided endoscopy parts manufacturing, extrusion processes, and secondary operations, within a regulated medical device environment.
The Manufacturing Engineer partners closely with Manufacturing Operations, Design Engineer, Quality, Supply Chain, and Engineering leadership to ensure manufacturing processes are capable, compliant, efficient, and scalable. This position applies sound engineering principles, data-driven problem solving, and Lean / continuous improvement methodologies to improve safety, quality, delivery, and cost performance while maintaining compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and all applicable regulatory and company requirements.
Essential Duties & Responsibilities:
Review and analyze production data to assess product types, volumes, specifications, yield, scrap, and process performance in order to optimize manufacturing operations.
Analyze manufacturing processes and methods, along with supporting data, to develop reports and recommendations that enable management to understand current performance and future manufacturing requirements.
Design, develop, and implement manufacturing processes, tooling, fixtures, and work instructions to support safe, efficient, and compliant production.
Support complex manufacturing processes, including braiding, extrusion, secondary operations, and precision assembly, ensuring processes are robust, repeatable, and capable.
Prepare and support engineering projects and coordinate activities to ensure production and quality objectives are achieved.
Review production and operating reports and assist in resolving operational, manufacturing, and equipment-related issues to optimize costs and prevent production delays.
Review and evaluate labor, material, and other production costs to support capacity planning, cost control, and operational decision-making.
Analyze and plan workflow, equipment placement, and space utilization to improve manufacturing efficiency and material flow.
Collaborate with Manufacturing and Finance on the annual development of product Standard Cost. Regularly review causes of significant unfavorable financial Std. Cost variances and develop necessary corrective actions.
Inspect machines, tooling, and equipment to ensure proper operation, process stability, and optimal utilization.
Evaluate quality control processes and collaborate with Quality to recommend and implement improvements.
Collaborate with Manufacturing and Quality to develop, revise, and maintain standard operating procedures, work instructions, and manufacturing documentation; observe manufacturing activities to ensure compliance with established standards.
Review existing tooling and equipment designs and recommend improvements to enhance process performance and reliability.
Research and evaluate automation techniques, equipment upgrades, and process improvements to improve productivity and consistency.
Test and evaluate new systems, processes, and equipment to assess efficiency, product flow, and manufacturability.
Identify sources of waste, variations, and inefficiencies within manufacturing processes and implement corrective actions using Lean/Six Sigma and continuous improvement principles.
Apply engineering and analytical methods to refine manufacturing systems and improve supply and production chain effectiveness.
Implement a Poka Yoke Program to significantly reduce human error and improve repeatability and consistency in the manufacturing processes.
Adjust production lines and integrate new technologies as needed to support changing production requirements.
Assist in training manufacturing personnel on new or revised processes, equipment, and standard work.
Read and interpret technical drawings, specifications, blueprints, tooling designs, and electrical or mechanical diagrams.
Participate in project planning and execution for small- and large-scale manufacturing initiatives.
Support manufacturing change control activities to ensure changes are implemented in a controlled and compliant manner.
Ensure manufacturing processes and equipment comply with all applicable company policies, regulatory requirements, and government laws.
Participate in process and equipment validation activities, including IQ/OQ/PQ, as required.
Support root cause investigations, nonconformances, and CAPA activities by providing technical analysis and corrective action recommendations.
Qualifications:
Bachelor of Science or higher in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or Manufacturing Engineering Technology.
Minimum of 3 years of Manufacturing Engineering experience within a regulated industry, preferably medical devices. 5 years preferred.
Experience supporting complex component manufacturing, including braided catheter manufacturing, extrusion, or precision assembly, preferred.
Working knowledge of FDA QSR and ISO 13485 requirements.
Experience applying Lean manufacturing or continuous improvement methodologies.
More about our client:
Client specializes in designing, prototyping, and manufacturing high-quality, highly engineered components and assemblies for the medical device and healthcare sectors, mostly providing critical life-saving products used in medical procedures related to cardiology, neurology, gastroenterology, orthopedics, and general surgery. Their specific expertise is in endoscopy, electrosurgery, vascular access, and other interventional procedures where precision and regulatory compliance are paramount.
Manufacturing capabilities include high-precision braiding, extrusion, laser processing, thermal forming, injection and insert molding, and advanced assembly. They offer rapid prototyping, design-for-manufacturing guidance, engineering support, and small-to-high volume scalable solutions. They work directly with R&D teams to accelerate product development.
Joining this team, you'll have an opportunity to work with cutting-edge manufacturing processes and support rapid medical industry innovation.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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