Engineering role (Development, QA & Compliance)
Project Overview:
- Transitioning from planning to testing, validation, and documentation of a medical device + app
- Focus on quality standards, API/README development, and FDA submission readiness
- Operating in a regulated environment with strong compliance and documentation needs
- Collaborative project with external partners and a cross-functional team
Responsibilities:
- Develop and execute testing protocols, including Design Verification Protocols (DVP)
- Perform hands-on lab testing (devices, droppers, placebos) and experimentation
- Collect, analyze, and report data for FDA filings
- Create and maintain technical documentation (reports, requirements, lab notes)
- Ensure compliance with design controls and documentation standards
- Support product transition to B2B outcomes
- Collaborate with internal teams and external partners
Required Skills:
- Experience in regulated/medical device environments
- Strong knowledge of quality, validation, and compliance practices
- Data analysis and technical documentation expertise
- Attention to detail and cross-functional collaboration
Preferred Skills:
- Lab or machine shop experience
- Exposure to extractables & leachables
- Familiarity with device-app integration and FDA processes
Pay range:
$40/hr. - $45/hr.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)