Process Development Engineer

Position Summary:

The Process Engineer is responsible for the development and implementation of the manufacturing processes for Nuvaira. Responsibilities include but are not limited to the development, organization, engineering and administration of all feasibility, laboratory, pilot testing and construction. The Process Engineer also leads PD/manufacturing engineering projects and provides support to the disposable manufacturing line.

Responsibilities:

  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation
  • Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements
  • Independently analyzes and solves engineering problems
  • Identifies and interfaces with suppliers and in-house personnel as necessary to accomplish project objectives
  • Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, IQ/OQ/PQ, FMEA’s, etc.)
  • Trains and/or provides work direction to technicians and may train manufacturing personnel when required
  • Supports compliance with all international, federal, state, and local regulatory requirements, including, but not limited to FDA, ISO, OSHA and hazardous waste handling
  • Adheres to and supports safety standards, Nuvaira policies and practices
  • Supports medical device manufacturing line
  • Other assignments as required

Qualifications:

  • Bachelor or higher degree in Engineering
  • 2+ Years of process development and/or manufacturing engineering in a regulated environment
  • Experience in Medical Device Manufacturing
  • Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)

Preferred Qualifications:

  • Solidworks experience
  • Lean Manufacturing experience
  • Catheter experience

Physical Job Requirements:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.