Manufacturing Engineer (Class II and III Interventional Devices)

Aptyx•Olympic Woods, NC

25d•Onsite

About The Position

The Manufacturing Engineer I–II is responsible for supporting and advancing the manufacturing of Class II and Class III interventional medical devices, including catheters, implants, and other complex disposable medical devices. This position works directly within the production environment to develop, transfer, validate, launch, troubleshoot, and continuously improve manufacturing processes. The Manufacturing Engineer partners closely with R&D, Operations, Quality, Supply Chain, and customers to transfer products and processes from development into repeatable, scalable production. The role requires a hands-on engineering approach, with a strong understanding of manufacturing processes, equipment, tooling, process validation, and production requirements within a regulated medical device environment. At Level I, the engineer develops foundational manufacturing engineering capabilities while supporting production transfers, process development, validation, and continuous improvement activities. At Level II, the engineer independently owns manufacturing processes and transfer activities, leads technical projects, resolves complex production issues, and serves as a key engineering partner to Operations and R&D.

Requirements

Experience in medical device manufacturing, manufacturing engineering, process engineering, or product transfer required.
Experience supporting the manufacturing of interventional medical devices, catheters, implants, or other complex disposable medical devices strongly preferred.
Working knowledge of manufacturing processes, equipment, tooling, materials, and process development.
Demonstrated ability to work hands-on in a production environment.
Understanding of medical device manufacturing requirements and process validation.
Experience with product or process transfer from development into production preferred.
Experience with Lean Manufacturing, Six Sigma, and structured problem-solving preferred.
Experience with SolidWorks or comparable CAD software preferred.
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline required.
1+ years of relevant engineering or manufacturing experience (for Level I).
Medical device manufacturing experience preferred (for Level I).
Demonstrated understanding of fundamental engineering and manufacturing principles (for Level I).
2–5 years of engineering experience, preferably within medical device manufacturing (for Level II).
Demonstrated experience with manufacturing process development, product/process transfer, validation, and production support (for Level II).
Experience independently troubleshooting and improving manufacturing processes (for Level II).
Experience leading engineering projects preferred (for Level II).
Strong understanding of manufacturing processes and production equipment.
Knowledge of process development and transfer methodologies.
Understanding of IQ, OQ, PQ, TMV, Gage R&R, and MSA.
Ability to interpret engineering drawings, specifications, and product requirements.
Proficiency with Microsoft Office and engineering documentation systems.
Experience with CAD software such as SolidWorks preferred.
Working knowledge of ERP systems.
Strong analytical, troubleshooting, and problem-solving skills.
Ability to work effectively in a hands-on production environment.
Strong written and verbal communication skills.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
Ability to collaborate effectively with technical and non-technical teams.
Ability to recognize process risks and make sound engineering recommendations.

Nice To Haves

Experience supporting the manufacturing of interventional medical devices, catheters, implants, or other complex disposable medical devices
Experience with product or process transfer from development into production
Experience with Lean Manufacturing, Six Sigma, and structured problem-solving
Experience with SolidWorks or comparable CAD software
Medical device manufacturing experience (for Level I)
Experience leading engineering projects (for Level II)

Responsibilities

Provide hands-on engineering support within the manufacturing environment to ensure processes consistently meet requirements for quality, delivery, productivity, and cost.
Develop, implement, and improve manufacturing processes for interventional medical devices, including catheters, implants, and other complex disposable products.
Support daily production by troubleshooting equipment, tooling, materials, processes, and product-related issues.
Investigate manufacturing issues using structured problem-solving and root-cause analysis techniques.
Develop and implement corrective and preventive actions that improve process capability, yield, reliability, and throughput.
Partner with Operations to establish efficient and repeatable manufacturing methods.
Support production builds, pilot runs, first builds, process trials, and production ramp-up activities.
Develop operator training and manufacturing process documentation as required.
Support the transfer of new and existing medical device products from R&D and development into production.
Translate product designs and development requirements into practical, manufacturable production processes.
Develop manufacturing processes, equipment, tooling, fixtures, workstations, and production methods required to support product launch.
Participate in transfer planning, including identification of manufacturing requirements, equipment, tooling, materials, labor, capacity, and process risks.
Execute manufacturing activities associated with product transfers, engineering changes, process changes, and production launches.
Work closely with R&D Engineering to ensure designs are transferred into production with appropriate consideration for manufacturability, process capability, quality, and cost.
Identify and resolve transfer issues prior to and during production launch.
Support successful transition from development builds to stable, repeatable production.
Develop and optimize manufacturing processes for complex interventional medical devices.
Evaluate, select, and implement manufacturing equipment, tooling, fixtures, and technologies.
Support equipment procurement, installation, commissioning, and qualification.
Develop process parameters and operating windows that support consistent product quality and manufacturing performance.
Conduct process trials and engineering experiments to evaluate and improve manufacturing methods.
Perform capacity analysis, line balancing, time studies, and process-flow analysis.
Evaluate opportunities for automation and semi-automation to improve quality, productivity, and scalability.
Work with equipment and tooling suppliers to resolve technical issues and implement manufacturing solutions.
Develop and execute process validation activities in accordance with the Aptyx Quality System and applicable medical device requirements.
Prepare and execute IQ, OQ, PQ, TMV, Gage R&R, and other applicable validation activities.
Develop and maintain manufacturing process documentation and validation records.
Support development and maintenance of pFMEAs, control plans, Master Validation Plans, process specifications, and related risk-management documentation.
Identify manufacturing risks and establish appropriate process controls.
Ensure validation activities demonstrate that manufacturing processes are capable of consistently producing product that meets established requirements.
Maintain accurate, complete, and audit-ready engineering and validation documentation.
Support manufacturing readiness activities from development through production launch.
Develop manufacturing processes and documentation necessary to support new product introduction.
Coordinate engineering activities required for pilot builds, first production runs, and production ramp-up.
Monitor early production performance and identify opportunities for process stabilization.
Partner with Operations and Quality to establish appropriate process controls and production metrics.
Evaluate production capacity and resource requirements to support current and future demand.
Support transition of processes from initial launch to sustained production ownership.
Identify and implement opportunities to improve safety, quality, delivery, productivity, yield, and cost.
Apply Lean Manufacturing and Six Sigma principles to improve manufacturing processes.
Analyze scrap, rework, downtime, cycle time, labor utilization, and other manufacturing performance indicators.
Lead or participate in continuous improvement projects that produce measurable operational results.
Conduct time studies and develop standard work to improve process consistency and efficiency.
Identify opportunities to reduce waste, improve flow, increase capacity, and optimize labor utilization.
Evaluate manufacturing costs and identify opportunities to reduce COGS without compromising quality or regulatory requirements.
Partner with R&D Engineering during product development to ensure designs can be efficiently and consistently manufactured.
Participate in DFM reviews and provide manufacturing input on product design, materials, tolerances, assembly methods, and process requirements.
Recommend design changes that improve manufacturability, yield, reliability, quality, and cost.
Identify potential manufacturing challenges early in the development process and work collaboratively with R&D to resolve them.
Follow the Aptyx Quality System, applicable SOPs, work instructions, and requirements identified within the Training Matrix.
Ensure manufacturing engineering activities comply with applicable medical device regulations and internal procedures.
Support compliance with requirements applicable to Class II and Class III medical devices.
Maintain appropriate engineering records and documentation to support internal and external audits.
Participate in investigations, CAPA, nonconformance, change control, and other quality-system activities as required.
Create, review, and maintain manufacturing engineering documentation, including: Work instructions, Process specifications, Manufacturing procedures, Bills of material (BOMs), Routings, Process flow diagrams, Control plans, Validation protocols and reports, Engineering change documentation.
Maintain accurate manufacturing and engineering information within ERP and other applicable systems.
Ensure manufacturing documentation accurately reflects current production processes.
Work with suppliers on materials, tooling, equipment, and manufacturing processes.
Support supplier qualification and validation activities.
Investigate material- or supplier-related manufacturing issues.
Support material changes and process changes through appropriate engineering and quality-system processes.
Partner with Supply Chain and Quality to resolve technical and material issues affecting production.
Collaborate with R&D, Operations, Quality, Supply Chain, and other functional teams to resolve manufacturing and transfer issues.
Communicate technical information, project status, risks, and manufacturing requirements clearly to internal stakeholders.
Participate in customer meetings and technical discussions related to manufacturing transfer, process development, validation, and production readiness.
Build effective working relationships across functions to ensure successful product transfer and production execution.
Escalate technical, quality, schedule, or resource risks appropriately.
Support or lead manufacturing engineering projects associated with new product introduction, product transfer, process improvement, equipment implementation, and production expansion.
Develop project plans, identify required resources, track deliverables, and communicate project status.
At Level II, independently manage assigned engineering projects with responsibility for scope, timing, technical execution, and deliverables.
Ensure engineering activities remain aligned with customer requirements, quality expectations, manufacturing needs, and business objectives.