Quality Engineer

• The manager is seeking a new batch of candidates to review. Highlighted below is where some of the individuals from the first round of interviews fell short.
• Technical depth in TMV, risk management and V&V. (Seeking experience both developing and executing the activities, not just being part of a team).
• Experience being part of integration efforts and/or major remediation efforts Some of the candidates, they spoke about TMV but they couldn't get into the technical depth so we are looking for those who have more experience

Requirements:

• Bachelors in Engineering or related.
• 4+ years of experience.
• Experience in NPD or Design Quality (21 CFR 820).
• Experience with design integration/DHF remediation.
• Experience with vascular devices (catheters, stents, guidewires etc.) is a huge plus.
• Design integration, design remediation, implementation of DFM principles and supporting risk management architecture.