The position is responsible for performing all aspects related
to the process and product development and ongoing support of the
implantable neurostimulator for the InCube Labs projects.
Major Duties and Responsibilities:
Work with the product development group (both electrical and
mechanical) to help implement the design of systems and ensure
design for manufacturability.
Become directly involved in the process development activities
including welding, molding, casting and finished device
Perform mechanical DVT testing activities.
Perform process validation activities.
Develop and maintain failure mode and effects analysis and
master validation protocols.
Control and document Manufacturing Process Instructions
Troubleshoot manufacturing processes
Train assemblers on new work instructions and new processes.
Drive completion of assembly lines, e.g. development line and
lines for clinical and production product.
Work cross-functionally with other engineers to work towards
Ensure product designs and modifications are completed according
to project timelines, quality standards and within budget.
Control and documentation of tooling and equipment
Run equipment calibration and equipment maintenance process
Education and/or Job Experience:
Min 3 Years in a small to medium scale Medical device
Familiarity with PC board manufacturing is a plus
Experience working with quality systems in a highly regulated
Skills and Specifications
Good mechanical lab and mechanical/process troubleshooting
Familiarity with an array of manufacturing processes such as
welding, encapsulation and packaging.
Good working knowledge of Solidworks CAD tools for mechanical
Knowledge of fixturing and tooling design.
Knowledge of statistical software such as Minitab.
Previous working experience with tray sealers, lasers, helium
leak testers, resistance welders, tensile testers, etching
equipment and/or various gas management systems is a plus.