Senior Manufacturing Engineer

3 weeks ago

Plymouth, United States Interrad Medical Full time

Summary

This role is responsible for all aspects, from planning to execution, of manufacturing the SecurAcath device, including managing suppliers, contract manufacturers, cleanroom operations, and working with engineering, operations, and quality.

This position is based in Plymouth, MN (on-site).


Responsibilities

  • Manage manufacturing and process development of nitinol-based medical components
  • Manage manufacturing and process development of plastic-based injection-molded medical devices (both insert molding including robotic handling and two-shot molding)
  • Manage suppliers of materials, components, and devices for manufacturing SecurAcath
  • Review and approve automation and injection molding design
  • Review and approve IQ, OQ, PQ, and first article protocols and reports
  • Review and approve process capability requirements and reports
  • Lead analysis of nonconforming components through Nonconforming Material Reports, Material Review Board, and Corrective and Preventive Actions
  • Implement plans to increase yield/ decrease scrap
  • Implement plans to decrease Cost of Goods Sold
  • Implement plans for increasing capacity and capabilities ahead of projected growth
  • Implement plans for material, component or equipment obsolescence
  • Facilitate supplier meetings; plan objectives, prepare agendas, facilitate discussion during meeting, and compiling minutes including actions and decisions
  • Develop and present insightful executive summaries and supplier performance scorecards
  • Provide technical support for receiving and inspecting components and packaging devices
  • Support internal product development projects including line extensions and next generation devices
  • Substantially contribute to risk analysis, risk-based decision making and risk management
  • Actual duties may include, but are not limited to, the preceding duties


Qualifications

  • Bachelor’s degree in mechanical engineering or materials science or equivalent is required
  • Ten years of medical device engineering experience required (vascular access and catheter experience preferred)
  • Significant experience working with suppliers and contract manufacturers for new product introductions and transfers
  • Significant experience designing and manufacturing nitinol-based medical components AND/OR injection-molded plastic-based medical devices required (multishot and insert molding preferred)
  • 3D CAD and PDM software (SolidWorks preferred)
  • Data analysis and statistical software (Minitab preferred)
  • Experience with clean room equipment and processes for manufacturing
  • Familiar with automated, electrical, optical, pneumatic, or robotic equipment for manufacturing
  • Familiar with measurement systems (SmartScope and Measure-X preferred)
  • Understanding of ISO 13485, ISO 14971, ISO 10993, and 21 CFR 820
  • Great attitude, communication and time management

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