Manufacturing Engineer Med Device

The Manufacturing Engineer III 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.

• 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 MSA 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.

• 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.

• Bachelors degree in Mechanical Engineering Biomedical Engineering Manufacturing Engineering or a related engineering discipline required.

Manufacturing Engineer I

• 1 years of relevant engineering or manufacturing experience.
• Medical device manufacturing experience preferred.
• Demonstrated understanding of fundamental engineering and manufacturing principles.

Manufacturing Engineer II

• 25 years of engineering experience preferably within medical device manufacturing.
• Demonstrated experience with manufacturing process development product/process transfer validation and production support.
• Experience independently troubleshooting and improving manufacturing processes.
• Experience leading engineering projects preferred.

• 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.

Level I: Applies foundational engineering principles and develops manufacturing knowledge with guidance.

Level II: Independently develops improves and troubleshoots manufacturing processes and equipment.

Level I: Supports product and process transfers and executes assigned transfer activities.

Level II: Independently owns manufacturing transfer activities and ensures successful transition into production.

Level I: Supports validation activities and maintains accurate engineering documentation.

Level II: Independently develops and executes validation activities and ensures processes are robust and compliant.

Level I: Uses structured problem-solving techniques to identify and address manufacturing issues.

Level II: Leads complex root-cause investigations and implements sustainable corrective actions.

Level I: Identifies opportunities for improvement and participates in Lean and continuous improvement activities.

Level II: Leads improvement initiatives and delivers measurable improvements in quality productivity capacity and cost.

Level I: Completes assigned engineering activities and meets established project commitments.

Level II: Owns engineering projects deliverables timelines and technical execution with minimal oversight.

Level I: Effectively communicates with team members and escalates issues when appropriate.

Level II: Serves as a technical partner to Operations R&D Quality Supply Chain and customers and drives cross-functional alignment.

Level I: Understands basic manufacturing cost drivers and identifies opportunities for improvement.

Level II: Evaluates manufacturing costs capacity labor yield and process performance to support cost-reduction and operational decisions.

• Successful transfer and launch of products and processes into production.
• Manufacturing processes that consistently meet quality delivery productivity and cost requirements.
• Timely and accurate completion of validation and engineering documentation.
• Effective resolution of production and process issues.
• Improvements in yield throughput capacity cycle time scrap and cost.
• Successful implementation of equipment tooling and manufacturing processes.
• Effective collaboration with Operations R&D Quality Supply Chain and customers.
• Successful execution of assigned engineering projects.
• Demonstrated growth in technical capability independence and ownership.

The physical demands described are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made.

This position requires regular sitting standing walking and use of hands for computer laboratory equipment and manufacturing activities. The employee may be required to work directly on or around manufacturing equipment and production processes. The role operates in both laboratory and manufacturing environments with variable conditions. Effective verbal and written communication and standard vision and hearing capabilities are required.

Required Experience:

IC