Supervisor, Delivery System (2nd Shift)

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Attention to detail

Fast-paced environment

Results orientation

Line layout optimization

Hands-on skills

Discipline administration

Training methodologies

ERP system

MS Office

Education

High School Diploma or higher

Job description

Job Title:

Supervisor, Delivery System

Supervisor/Manager Title:

Manager, DS Manufacturing

Job Description Summary:

Development and Supervision of team in conducting Delivery System builds and technical training activities. Support for manufacturing & R&D tasks associated with new production development and commercialization of transcatheter heart valve delivery systems. Champion change management throughout the manufacturing process and drive technical advancements with an emphasis on culture grounded in mistake-proofing, continuous improvement, and compliance to procedures.

Job Responsibilities:

Production Responsibilities:

• Effective planning, organization, control, and supervision of the manufacturing process.
• Technical training and knowledge of delivery system assembly techniques.
• Set department goals/expectations and provide performance feedback to delivery system assemblers.
• Ensure compliance to regulations (FDA, OSHA, etc.) and compliance to manufacturing procedures.
• Participate in Material Review Boards (MRB) for production disposition.
• Partner effectively with Quality Engineering, Manufacturing Engineering, and Quality Assurance to monitor department quality and support corrective actions.
• Assist Engineering in root cause analysis investigation for component and device nonconformance.
• Assist in the process development and validation for new product introductions and continuous improvement projects.
• Support development assembly methods and procedures, as required.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.

Technical Training Responsibilities:

• Supervise technical training team and training activities including, but not limited to ensuring staff is appropriately trained to perform assigned work and EHS requirements, management of training materials, assist with delivery and collection of productivity, quality, and training metrics of staff and trainees, provide regular progress reports and training metrics to management and cross-functional stakeholders, oversee and coach daily execution of trainer methods and tools.
• Accountable for learning curve and quality metrics of staff and provide regular progress reports to management and cross-functional stakeholders, and leading improvement opportunities related to the transition and integration of new and certified employees into production/commercial activities with responsibilities for all project outcomes of assigned unit/group of employees.
• Provide feedback and/or conduct performance reviews of Technical Training staff including resolving performance issues.
• Develop, plan, and schedule training activities.
• Analyze workmanship deficiencies in production and implement corrective measures within the training program.
• Accountable for all post training effectiveness programs, metrics and responses required to monitor and or improve performance.
• Prepare training records and reports to ensure audit compliance.

Qualifications:

Required Education and Experience:

• 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.

Skills And Abilities Required For This Job:

• Attention to detail and the ability to work in a fast‑paced changing environment is key.
• Results orientation, accountability, and project ownership.
• Ability to analyze and adjust line/operation layouts to improve efficiency.
• Strong hands‑on skills with proven ability to apply technical knowledge and judgment to complex technical problems.
• Ability to establish a culture of positive reinforcement along with being comfortable administering discipline when required.
• Solid working knowledge of training related methodologies and effectiveness measures.
• Knowledge in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system.
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders to achieve objectives, as well as mediating and negotiating the needs of other areas to achieve consensus.