Machine Design Engineer

Bedford, Massachusetts, United States | Full-time

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As a Machine Design Engineer at Affera, you will support the development and launch of Affera’s class II and III medical devices from development through regulatory approval and commercial release. This is a high impact role, applying manufacturing and quality engineering principles to assist the R&D team in transitioning from the development stage through V&V in accordance with FDA QSR guidelines.

We are looking for bright individuals who are interested in making a difference in a dynamic and exciting entrepreneurial environment.

Responsibilities:

  • Manufacturing process development for complex catheter assemblies containing miniature, precision electromechanical components.
  • Development of manufacturing documentation including: inspection, assembly and test procedures; purchase specifications; BOMs; routers; part and assembly drawings.
  • Management of documentation changes using appropriate change control procedures.
  • Design and development of jigs, fixtures and other equipment for catheter assembly, inspections and testing.
  • Implementation of material control procedures from material receipt through final assembly.
  • Management of laboratory and prototyping space and equipment.
  • Hands-on assembly and testing of devices to support development, pre-clinical and V&V activities.
  • Address quality issues, including issuing non-conformance reports and managing Corrective and Preventive Actions.
  • Use Design for Manufacturability (DFM) and statistical techniques to ensure the manufacturability and robustness of the product.
  • Participate in design reviews and assist with Design and Process Failure Mode and Effects Analyses (FMEA).
  • Interface with vendors including procuring materials, resolving issues and transferring processes to OEM vendors.
  • Train and supervise assembly and test technicians.

Qualifications and Experience:

  • B.S. in Mechanical or Biomedical Engineering.
  • Minimum of 3 years of manufacturing experience for an electromechanical medical device, preferably a catheter-based product.
  • Experience with new product introduction (NPI) and development of manufacturing and test processes.
  • Highly motivated and thrives in a fast-paced environment with little direction.
  • Team-oriented spirit and ability to work cross-functionally across departments.
  • Highly organized; strong attention to detail.
  • Solid background in process/product V&V.
  • SolidWorks CAD skills.
  • Excellent verbal and written communication skills, including ability to effectively interface with design engineering teams.
  • Experience with packaging and sterilization of disposable medical devices is a plus.

Perks:

  • Contribute to an innovative solution that can improve the lives of millions.
  • Learn under the guidance of some of the industry's prominent experts in the field of medical device engineering.
  • Bright, motivated co-workers in a fun and collaborative office environment.
  • Competitive salary, 401k, generous medical coverage to suit your needs.