As a Manufacturing Engineer at Affera, you will support the development and launch of a novel, minimally invasive device from prototyping stages 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 prototype 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.
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 5 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.
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.
New office location in restored "brick and beam" office space along the Charles River.
Bright, motivated co-workers in a fun and collaborative office environment.
Competitive salary, generous medical/dental/vision coverage to suit your needs.
Affera is a venture-backed medical device company founded by a seasoned team of leaders in the industry. We are developing a game-changing, innovative system to treat heart rhythm disorders, one of the fastest growing fields in medical devices. Affera represents an opportunity to make a real difference in the lives of millions of patients worldwide.
We are a highly selective team of super-talented individuals whose aim is to have a major impact on developing a breakthrough, life-saving technology. We believe in maximizing the unique talents of each individual, empowering everyone to contribute on multiple levels. If you are innovative, resourceful and hands-on, we want you on our team!
Wed, 13 Sep 2017 07:45:04 PDT