Bachelor's degree in Engineering or related field.
4+ years of relevant experience in the industry.
Knowledge of NPD or Design Quality standards (21 CFR 820).
Hands-on experience with design integration and DHF remediation.
Familiarity with vascular devices such as catheters, stents, and guidewires is a strong advantage.
Expertise in design remediation and implementation of DFM principles.
Responsibilities
Review a new batch of candidates and provide feedback on deficiencies in previous interview rounds.
Demonstrate technical depth in TMV (Test Method Validation), risk management, and V&V (Verification and Validation).
Lead integration efforts and manage major remediation before product launch.
Engage deeply with candidates to assess their experience and technical depth in TMV and related areas.
Benefits
Dynamic work environment fostering professional growth and development.
Opportunities for collaboration with cross-functional teams.
Full Job Description
Responsibilities:
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.
