Manufacturing Engineer

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- ISO
13495 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…