Engineer I

Engineer I

Location: Madison, WI

Reports to: Program Manager, Engineering

About the job

We are seeking a full time (40 hours / week) Engineer I in our Madison Lab to support our Engineering team.

This Engineer supports the Research & Development teams in the development of the Beyond Air medical product line. They are familiar with the R&D life cycle from preliminary analysis to tests and deployment.

In This Role, You'll Be Accountable for:

• Cross-functional collaboration with the R&D team
• and
• Creation / Production of documentation to satisfy Medical Standards & FDA Guidance.

In this Role your Activities will include:

• Providing manufacturing engineering support to the R&D Operations Team
• You will define & implement specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results.
• Responsible for validation work including writing and executing validations.
• You will resolve in-house and supplier quality problems using established problem-solving methodologies.
• You will participate in the development and improvement of the manufacturing process for existing and new products.
• You will review & approve inspection plans, routers and product drawings
• You will facilitate quality remediation, gap closure through partnership with Quality Engineers.
• Support with initiating and closure of non-conformance and corrective and action preventative actions.
• Supporting projects, bringing in capital equipment for new manufacturing lines and upgrades to existing lines.
• You will work cross functionally with teams for projects and initiatives including lean manufacturing, added capacity and new product launches.
• Provide technical support for quality control, process improvement, cost savings, process development projects, new product launches, equipment qualifications, and process validations.
• Produce documentation such as, inspection plans, equipment maintenance logs and standard operating procedures.
• Support continuous improvement efforts by performing time studies, flow analysis and other lean related tasks.
• Make proposals/recommendations in support of the team to help achieve team goals in quality, cost, delivery and safety.

Qualifications

Required

• BA degree in Engineering, (Biomedical or Industrial Engineering Preferred).
• 1 year of experience in an Engineering Department for Medical Devices
• Experience in regulated manufacturing environment preferred
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Excellent written and verbal communication skills
• High attention to detail with a disciplined, process-oriented mindset

The job is office-based in Madison, Wisconsin

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.