The Manufacturing Engineer is responsible for the development, implementation, improvement, and support of the manufacturing processes for Nuvaira. Responsibilities include but are not limited to tooling design, process capability analysis, process quality requirements, process cycle time/lean manufacturing, and technology investigation. The Manufacturing Engineer will need to have a working understanding of process characterization tools and be able to leverage them across different technologies.
- 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
- Bachelor or higher degree in Engineering
- 5+ Years of process development and/or manufacturing engineering in a regulated environment
- Experience in process validation (IQ, OQ, PQ); ability to prepare validation protocols, execute validations, and write validation reports
- Experience in small component assembly
- Proficient in CAD (SolidWorks highly desired)
- Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)
- Lean Manufacturing experience
- Catheter experience
- Strong technical, written and verbal communication skills
- Strong organizational and interpersonal skills
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.