ABOUT THE OPPORTUNITY
This is a rare opportunity to step into a high-impact process engineering role at a genuine inflection point. SANSA combines a multi-functional wearable patch with an AI-powered cloud interface and clinical workflows to deliver a category-defining diagnostic platform at the intersection of sleep medicine and cardiology.
If you are hands-on with electronic systems, comfortable writing Python scripts, and energized by solving hard manufacturing, process, and fulfillment problems in a regulated environment, this role was built for you.
THE ROLE
We are seeking a Process Engineer with approximately 3 years of experience to join our operations team. You will own the development, optimization, and troubleshooting of manufacturing and test processes for our electronic medical devices — playing a direct role in bringing SANSA to patients at scale.
KEY RESPONSIBILITIES
- Develop, maintain, and optimize manufacturing and test processes for electronic medical devices
- Create and improve Python-based scripts for automated testing, data collection, and manufacturing support
- Identify, analyze, and improve process flow across manufacturing and order fulfillment to improve throughput, quality, reliability, and efficiency
- Troubleshoot issues related to electronic test equipment, manufacturing fixtures, PCB assemblies, and devices returned from the field
- Support root cause investigations and corrective/preventive actions (CAPA)
- Collaborate with Manufacturing, Quality, and Engineering teams to resolve production issues
- Design and implement process improvements, fixtures, and tooling to support scalable manufacturing
- Monitor manufacturing metrics and identify continuous improvement opportunities
- Assist with validation activities including IQ/OQ/PQ and process documentation
- Maintain compliance with FDA, ISO 13485, and GMP requirements
- Support new product introduction (NPI) and product transfers to contract manufacturers
- Perform first-pass troubleshooting of SANSA devices; own clearance of the quarantine cage and maintain a running database of failures, failure codes, and remedies
- Aggregate and characterize device failures, including verifying correct application of failure codes and tracking quantitative data for engineering reference
QUALIFICATIONS
Required
- Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Manufacturing, or related field)
- Approximately 3 years of process engineering or manufacturing engineering experience
- Hands-on experience in a manufacturing environment involving electronic products or devices
- Strong Python scripting skills for automation, testing, or data analysis
- Experience troubleshooting electronic systems and test equipment
- Knowledge of process improvement methodologies and manufacturing best practices
- Strong analytical and problem-solving skills with excellent cross-functional collaboration
Preferred
- Experience in the medical device industry or another regulated manufacturing environment
- Familiarity with PCB assemblies, soldering processes, or electronics manufacturing
- Experience with automated test systems and instrumentation
- Familiarity with data acquisition systems, serial communication, or hardware interfaces
- Working knowledge of FDA regulations, ISO 13485, and GMP practices
TECHNICAL SKILLS
- Python scripting and test automation
- Electronic troubleshooting and diagnostics
- Process optimization and continuous improvement
- Automated test systems and instrumentation
- PCB and electronic assembly knowledge
- Data analysis and reporting
- Manufacturing documentation and validation (IQ/OQ/PQ)
WHO YOU ARE
- A hands-on, detail-oriented engineer who is equally comfortable working independently and across teams
- A self-starter who digs into technical problems and follows them through to resolution
- Organized and able to manage multiple workstreams in a fast-paced, collaborative environment
- Someone who takes pride in the quality and reliability of what they build
Pay: $75,000.00 - $105,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
