Process Validation Expert

Join Vectorious in Shaping Tomorrow's Healthcare! 🌐

Vectorious Medical Technology seeks a Validation Expert to innovate healthcare globally. With successful in-heart microcomputer implants, our breakthroughs have a huge potential to help millions of individuals with heart failure manage their condition effectively, leading to stability, fewer hospitalizations, and extended, fulfilling lives. Our innovative V-LAP device allows remote monitoring of the heart’s left atrial pressure, providing accurate daily physiological data from the comfort of home.

If you're passionate about making a difference and have the skills to contribute, apply today for an exciting opportunity!

Responsibilities

• Establish Performance and Quality Criteria- develop criteria to evaluate the effectiveness of processes.
• Design and Execute Testing Protocols: Create and implement testing procedures, and analyze data from validation tests and document results.
• Evaluate Production Systems and Processes- assess the functionality, safety, and performance of systems.
• Identify areas for improvement and recommend corrective actions.
• Troubleshoot Issues: Investigate and resolve any system-related issues, ans collaborate with engineers and technicians to address challenges.

Qualifications

• Experience: 7+ years in validation engineering, development, or a related role, with 3+ years in a senior or leadership position within the medical device industry (Class II/III).
• Validation & Quality Assurance: Deep expertise in validation processes (IQ, OQ, PQ), PFMEA, test method validation, and quality management systems. Proven ability to lead and approve projects with a focus on process capability, risk management, and continuous improvement.
• Technical Background: Strong product development or engineering foundation, with additional experience in design and quality roles being a significant plus.
• Statistical & Analytical Skills: Proficient in statistical analysis tools ) JMP, Minitab) and capable of driving decisions through data analysis.
• Leadership & Collaboration: Demonstrated leadership in guiding multidisciplinary teams, with excellent problem-solving and communication skills to work effectively across functions.
• Education: Bachelor’s or Master’s degree in Materials, Mechanical, Electrical Engineering, or a related field. Advanced degrees or relevant certifications are a plus.