Test and Analysis Engineer specialized in analysis of CO2 adsorbent products and systems within our ISO 13485 certified quality management system. This role will work closely with and report to the Head of Engineering and CTO. Responsibilities include design statistically sound experiments (DoE), execute rigorous bench testing, and ensure all data analysis and documentation meet strict regulatory requirements for patient/user safety and product efficiency.
Responsibilities and Duties: Design of Experiments (DoE) & Statistical Planning:- Develop and execute DoE strategies to identify critical-to-quality variables for medical consumables.
- Apply statistical methods (e.g., Gage R&R, sampling plans, and hypothesis testing) to validate test methods and product performance.
Testing & Data Analysis:- Create, validate, and execute test methods, protocols, and procedures for new products or prototypes.
- Collect, process, and analyze experimental data, turning raw results into technical reports and insights to guide design decisions. This position will include training in the use and execution of designed experiments.
- Design, build, and maintain customized test fixtures, apparatus, and instrumentation (e.g., sensors, DAQ systems).
- Analyze complex datasets using software like Minitab to identify trends, patterns, and potential failure modes.
Cross-Functional Collaboration:- Work with R&D, Product Design, Manufacturing, and Quality teams to define and refine products and their performance.
ISO 9001, ISO 13485, MDSAP Compliance & Documentation:- Ensure all test reports adhere to Good Documentation Practices (GDP).
- Ensure 100% traceability between design requirements, risk mitigations, and test results via a Traceability Matrix.
- Ensure testing complies with standards (e.g., FDA, ISO 9001, 13485, MDSAP) and maintain high safety standards in the lab, including handling hazardous materials if required.
- Verification & Validation (V&V)
Continuous Improvement:- Support Corrective and Preventive Action (CAPA) and root cause analysis (RCA) for non-conformances identified during testing.
Demonstrated Skills:- Communicate with Head of Engineering and CTO regarding progress regularly
- Ownership and passion to get the job done
- Use the quality system as a backbone to constantly improve
- Make sure improvements are in writing in the quality system, not just in a conversation that gets lost
- Strong organizational and interpersonal skills
- Team player and able to build and maintain relationships
- Flexible to change and open to constructive feedback
- Able to work independently with minimal supervision
- Represent the company in a professional manner at all times
This position description is intended to outline the primary responsibilities of the role and is not an exhaustive list. Additional duties may be assigned by supervisors based on business needs.
Benefits- Group Medical Insurance
- Group Dental Insurance
- LTD, STD, and Life Insurance
- 401K Retirement Savings Plan with company match
- Access to voluntary insurance programs via Colonial Life
- 80 Hours of Paid Time Off
- Eight holidays
