KORU Medical Systems is a leading developer and manufacturer of medical devices that help patients have the best possible experience subcutaneously infusing biologic medications at home. KORU’s primary line is the FREEDOM Syringe Infusion System, including the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The Company maintains its corporate headquarters and manufacturing facility in Chester, New York. For more information about the Company, please visit www.korumedical.com.
The Senior Design Assurance Engineer provides support to both new product development and sustaining engineering improvement initiatives for existing product lines. This person uses statistical analysis, test method development, engineering principals, and awareness of relevant procedural and regulatory requirements to move projects and initiatives to successful completion. The Senior Design Assurance Engineer will be responsible for device risk management files and ensuring risk activities are properly conducted.
What you will do:
- Ensure compliance of design controls per regulations and internal process requirements
- Review and maintenance of risk management files, including risk analysis documentation
- Review of test protocols to ensure compliance with QMS processes, with sufficient statistical justification for sampling and acceptance criteria
- Review sampling plans for adequacy by applying attribute, variable, and sequential sampling methods
- Identify applicable quality standards and appropriate test methods for the assessment of design performance
- Maintain Quality Department responsibilities for design change and new product development
- Analyze data by completing hypothesis testing, 2 sample t-tests, and process capability analyses
- Perform experiments, applying accepted design of experiment techniques
- Ensure design and product quality are maintained and well documented
What you need:
- Bachelor’s degree in engineering or other technical discipline
- 7-10 years of work experience in a similar role, ex. Design Engineering, Quality Engineering
- Experience with product development life cycle, design and development, risk management, and design/process verification/validation
- Ability to perform and review risk analysis tools (FMEAs, Hazard Traceability Matrices)
- Ability to review and perform Root Cause Analysis
- Statistical analysis
- Ability to read and interpret CAD drawings
- Self-starter, ability to work independently, and comfortable being a subject matter expert within the company
- Experience in the medical device field (Experience with FDA 21 CFR 820, ISO 13485, MDSAP, ISO 14971)
- Preferred: Experience with Biocompatibility and/or Sterilization monitoring of sterile medical devices
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
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