Supervisor, THV Production

Jenavalve Technology; Irvine (CA); On-site; USD 87,075 - 106,425; Full time

Job summary

Jenavalve Technology in Irvine, CA is seeking a Supervisor for THV Production to lead the production team for second shift operations. This role encompasses effective planning, organization, and supervision of manufacturing processes, while also focusing on coaching and mentoring staff.

The ideal candidate has 3+ years of experience in production supervision, possesses knowledge of medical device industry standards, and thrives in a fast-paced environment. We offer a supportive workplace that emphasizes safety and quality.

Qualifications

• Minimum of 3 years’ experience in production supervision and operations-related functions.
• Knowledge of industry-standard practices in the medical device industry.
• Experience working within cross-functional teams.

Responsibilities

• Lead production team resources for THV operations for second shift.
• Monitor and evaluate job performance while fostering team morale.
• Coordinate solutions mixing activities for production needs.

Skills

Lean Manufacturing

Six Sigma

Attention to detail

Strong communication

Education

Higher education degree preferred

Tools

Microsoft Office Suite

Job description

Job Details

• Job Title: Supervisor, THV Production
• Job Location: Irvine, CA 92618
• Position Type: Full Time
• Education Level: High School
• Salary Range: $96,750.00 - $96,750.00
• Role Level: People Manager
• Supervisor/Manager Title: Manager, THV Production
• Environment: Corporate Office and Cleanroom in Irvine, CA
• Shift: Second Shift – regular onsite presence during second shift operating hours

Job Description Summary

Responsible for leading production team resources for THV operations for second shift, including Tissue Processing, Valve Assembly, Solutions Mixing and Tool cleaning areas associated with new product development and commercialization of transcatheter heart valves.

Champion change management throughout the manufacturing process and drives technical advancements with an emphasis on culture grounded in mistake-proofing, continuous improvement, compliance to procedures, six‑sigma, and lean principles.

Job Responsibilities

• Effective planning, organization, control, and supervision of the manufacturing process.
• Leads production staff through coaching, mentoring, and performance feedback; monitors and evaluates job performance while promoting team morale and fostering collaboration within the team and across departments.
• Provides technical support for processes, including troubleshooting process issues and guiding staff on procedures.
• Accountable for learning curve and quality metrics of staff and providing 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.
• Supports product evaluation and disposition decisions while ensuring processes are performed according to established requirements.
• Coordinates completion of tasks by planning schedules, aligning resources, and ensuring materials, equipment, and personnel are prepared to support successful execution of the process.
• Coordinates solutions mixing activities by ensuring accurate preparation of required solutions, verifying availability of materials and equipment, and aligning schedules with production needs.
• Monitors inventory levels, coordinates with supply chain and procurement teams to maintain appropriate stock levels, and supports demand forecasting based on production schedules.
• Monitors, maintains, and drives performance against key production KPIs and operational metrics, including safety, quality, throughput, productivity, on‑time delivery, efficiency, scrap, and attendance, implementing corrective actions to ensure departmental goals are achieved.
• Collaborates in investigations and corrective actions to improve quality issues.
• Supports all manufacturing transfer‑related aspects of the project within a team environment.
• Maintains a safe, clean, and secure working environment by establishing and enforcing procedures, rules, and regulations.
• Ensures compliance with Corporate Quality System Manual and GMP procedures by initiating and monitoring related training programs.

Qualifications

• Higher education degree preferred.
• Minimum of 3 years’ experience in production supervision and operations‑related functions.
• Knowledge of 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

• Experience implementing Lean Manufacturing and Six Sigma concepts is desirable.
• Attention to detail and the ability to work in a fast‑paced environment.
• Results orientation, accountability, and project ownership.
• Strong hands‑on skills with proven ability to apply technical knowledge and judgment to complex technical problems.
• Knowledge of Microsoft Office Suite.
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross‑functional stakeholders to achieve objectives.

Physical Requirements

Ability to perform duties in both office and manufacturing environments.