Delivery System Manufacturing Supervisor

JenaValve Technology, Inc.; Irvine (CA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

JenaValve Technology, Inc. is seeking a Supervisor, Delivery System to lead the delivery system manufacturing team in Irvine, overseeing production planning, training, and continuous improvement initiatives.

Responsibilities include ensuring regulatory compliance, directing process development, and collaborating with cross-functional teams to drive quality and efficiency in a regulated medical device environment.

Formación

• High school degree or higher education.
• Minimum of 8 years’ experience working in a production environment.
• Knowledge of delivery system assembly, delivery system processes, and industry-standard practices in the medical device industry or other regulated industries.
• Experience working and collaborating within cross-functional teams.
• Experience taking initiative and conducting hands‑on work.

Responsabilidades

• Plan, organize, control, and supervise the manufacturing process.
• Provide technical training and supervise delivery system assembly techniques.
• Set department goals and provide performance feedback.
• Ensure compliance to regulations (FDA, OSHA) and manufacturing procedures.
• Participate in MRB for production disposition.
• Collaborate with Quality Engineering, Manufacturing Engineering and QA to monitor quality and support corrective actions.
• Assist Engineering in root cause analysis for nonconformance.
• Assist in process development and validation for new product introductions and improvements.
• Develop assembly methods and procedures and support changes.
• Adhere to EHS rules and prevent injuries.

Conocimientos

Attention to detail

Fast-paced environment

Results orientation

Line layout optimization

Hands-on skills

Discipline administration

Training methodologies

ERP system

MS Office

Educación

High School Diploma or higher

Descripción del empleo

JenaValve Technology, Inc. is seeking a Supervisor, Delivery System to lead the delivery system manufacturing team in Irvine, overseeing production planning, training, and continuous improvement initiatives.

Responsibilities include ensuring regulatory compliance, directing process development, and collaborating with cross-functional teams to drive quality and efficiency in a regulated medical device environment.