What are the responsibilities and job description for the Validation Engineer position at EnIn Systems?
Key Responsibilities:
- Lead validation activities for medical devices, software, or systems, ensuring compliance with FDA, ISO, and other regulatory standards (e.g., 21 CFR Part 820, ISO 13485).
- Develop, review, and execute validation protocols (IQ, OQ, PQ), including writing validation plans, reports, and specifications.
- Coordinate and lead cross-functional teams to complete validation tasks and support product lifecycle management.
- Review and approve engineering changes and deviations, ensuring that validation is maintained throughout the product lifecycle.
- Perform risk analysis and implement corrective actions to resolve issues in the validation process.
- Conduct design reviews and ensure validation requirements are addressed early in the design phase.
- Maintain and update documentation to ensure that all validation processes are well-documented and easily auditable.
- Provide technical leadership and mentorship to junior validation engineers.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure effective validation execution.
- Ensure that validation processes align with company quality systems, processes, and objectives.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Minimum of 7 years of experience in validation engineering, preferably in the medical device or regulated industry.
- In-depth knowledge of FDA regulations, ISO standards, and other applicable industry guidelines (e.g., 21 CFR Part 820, ISO 13485).
- Experience with risk management tools such as FMEA, HACCP, or similar methodologies.
- Strong problem-solving skills and attention to detail.
- Ability to work in a fast-paced environment and manage multiple projects simultaneously.
- Excellent communication and interpersonal skills.
- Familiarity with computer software validation (CSV) and automation validation is a plus.
- Experience with 3D printing, digital health, or software as a medical device (SaMD) is a plus.
Preferred Qualifications:
- Certification in Validation (e.g., ISPE, ASQ, or other related credentials).
- Experience with Lean Six Sigma or other process improvement methodologies.
- Familiarity with risk management and quality management systems in the medical device industry.
