Catheter production equipment operation experience
Validation strategy iq oq pq execution
Confluent Medical Technologies is seeking a Senior Manager to lead engineering activities for rapid prototype to high volume production of medical devices
Job Summary
Confluent Medical Technologies is seeking a Senior Manager to lead engineering activities for rapid prototype to high volume production of medical devices.
The role requires managing a team of engineers and technicians while overseeing the full lifecycle of catheter process development and validation.
Candidates must possess extensive hands-on experience with specific catheter production equipment and materials such as Nitinol, Pebax, and various polymers.
Matching Summary
Confluent Medical Technologies is seeking a Senior Manager to lead engineering activities for rapid prototype to high volume production of medical devices.
Skills & Requirements
Must-have
Process development from prototype to production
Catheter production equipment operation experience
Validation strategy IQ OQ PQ execution
Team management of engineers and technicians
DMR documentation creation and maintenance
Nice-to-have
Six Sigma Black Belt certification preferred
Strong English communication skills required
Experience with complex catheter assemblies
Knowledge of diverse medical device materials
Ability to train pilot production staff
Key Requirements
BS degree plus 12 years experience or MS/PhD with fewer years
Minimum 2 years leadership and people management experience
Must not require visa sponsorship or time-limited visa status