Manufacturing Engineer

General Information

Name


Manufacturing Engineer


Employment Type


Direct Hire


Position level


Full-time


Virtual/Remote?


No


Labor Category


Engineering


Date


04-Jun-2026


City


St. Louis


State


Missouri


Country


United States


Ref #


9247848435


Description & Requirements

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. product development life cycle experience and medical device manufacturing are 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.


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 will support endoscopy insertion tube development line, partnering with Manufacturing Operations, Design Engineers, 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:
Design and optimize robust, compliant, and scalable processes from prototype through high-volume production (This capability is essential in a highly regulated and innovation-driven environment where quality, compliance, and effective transfer from R&D to manufacturing are critical to business success).
Review and analyze production data to assess product types, volumes, specifications, yield, scrap, and process performance in order to optimize manufacturing operations.
Design for Manufacturability (DFM): Early involvement in the product development cycle- apply DFM principles, recommend design changes that reduce costs, improve quality, and enhance ease of manufacturing and assembly.
Process Development & Validation: Owning and developing the manufacturing process-from prototyping to IQ/OQ/PQ validation.
Cross-Functional Collaboration: Partner closely with R&D, Quality, Regulatory, and Operations throughout the product life cycle to ensure manufacturing process and documentation meet FDA, ISO 13485, and other regulatory requirements from the outset, minimizing late-stage issues or delays.
Change Control & Continuous Improvement: Manage changes during development (as products are refined or as production ramps up).
Foundational team member for implementing, documenting, and validating continuous improvements without risking compliance.
This role supports rapid prototyping and process scale-up for new and highly engineered medical devices- quickly identifies manufacturing needs, reduces time to market, and supports innovation-key differentiators in medical technology.
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 medical devices.
Product Development Life Cycle experience (it is critical for the hire in this role to understand how a product moves from concept through development, validation, launch, and sustained production. Life cycle experience is critical for this role to anticipate design challenges, manufacturability issues, and scalability from the earliest phases, ensuring smoother transfer of new products to manufacturing).
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.

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