Duties: Responsible for gathering systems requirements and developing processes with compliance in regulatory standards built into their design. Streamline operations and enhance process efficiency through innovative process development. Optimize and improve processes to eliminate variables, save time, and reduce costs to facilitate rapid iteration and innovation. Evaluate efficiency over time, moving from one method to another as they continue to be built and optimized. Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills. Assist with deviation and audit findings, track, ensure their effective execution, and coordinate timely closure of actions. Implement systems that drive compliance and optimize performance and recommend technical process changes to improve quality. Develop operational processes and communicate technical information to regulatory agencies. Develop quantifiable metrics displayed in real-time on a dashboard using relevant tools such as Excel, Grafana, and Google Sheets.
Education: Master's or foreign equivalent in Chemical Engineering or related field
Experience: 2 years of experience in job offered or related occupation.
Special Requirements: Must have at least 1 year of prior work experience in each of the following:
- Performing Gauge R&R study and applying measures (e.g., Cp, Cpk) for process capability analysis and SPC methods for quality enhancement.
- Using Lean principles to drive continuous yield improvement.
- Leading development of product characterizations and biocompatibility testing, DOEs, and validation protocols, leveraging statistical analysis (e.g., hypothesis testing, ANOVA) to drive data-driven decision-making.
- Leading development of strategic plans, aligning project goals, optimizing resource allocation, and implementing actionable strategies to drive improvements in quality, throughput efficiency, and market readiness
- Performing system-level testing and implementing QC measures aligned with product specifications to uphold quality standards, while overseeing SOP documentation to ensure regulatory compliance.
Salary: $145,000 - $165,000 USD
Worksite: Austin, TX
What We Offer:Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
