What are the responsibilities and job description for the Validation Engineer position at Fusion Life Sciences Technologies LLC?
Job Title: Validation Engineer
Location: Minnesota (Onsite)
Experience: 6–8 Years
Industry: Medical Device
Job Description:
We are seeking a skilled Validation Engineer with 6–8 years of hands-on experience in Test Method Validation (TMV) and Inspection Method Validation (IMV) in the medical device industry. The ideal candidate will support validation activities for new product development and manufacturing processes in compliance with FDA regulations and ISO standards.
Key Responsibilities:
- Plan, develop, and execute TMV and IMV protocols and reports.
- Collaborate with cross-functional teams including R&D, Quality, and Manufacturing.
- Analyze data and provide recommendations for method improvements.
- Ensure compliance with regulatory requirements (FDA, ISO 13485, etc.).
- Support root cause investigations and CAPAs related to validation.
- Maintain detailed documentation and validation records.
Requirements:
- Bachelor’s degree in Engineering or related field.
- 6–8 years of experience in TMV/IMV within the medical device industry.
- Strong knowledge of validation principles and regulatory guidelines.
- Experience with statistical analysis tools (e.g., Minitab).
- Excellent communication and documentation skills.