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Lead the second shift production team for transcatheter heart valve operations, overseeing tissue processing, assembly, and solutions mixing. Drive operational excellence through continuous improvement, compliance with GMP procedures, and the management of key performance indicators.
Requires a minimum of 3 years of experience in production supervision within the medical device or a similarly regulated industry. A higher education degree is preferred, along with proficiency in Lean Manufacturing and Six Sigma concepts.
Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: High SchoolSalary Range: $96,750.00 - $96,750.00 SalaryJob Title: Supervisor, THV Production
Job Location & Environment: Irvine, CA – Corporate Office and Cleanroom.
Shift: Second Shift – This position requires regular onsite presence during second shift operating hours.
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.
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 fosters collaboration within the team and across departments.
Provide 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.
Ability to support product evaluation and disposition decisions while ensuring processes are performed according to established requirements.
Coordinate completion of tasks by planning schedules, aligning resources, and ensuring materials, equipment, and personnel are prepared to support successful execution of the process.
Coordinate solutions mixing activities by ensuring accurate preparation of required solutions, verifying availability of materials and equipment, and aligning schedules with production needs.
Monitor inventory levels, coordinate with supply chain and procurement teams to maintain appropriate stock levels, and support demand forecasting based on production schedules.
Monitor, maintain, and drive 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.
Collaborate in investigations and corrective actions to improve quality issues.
Support 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.
Ensure compliance with Corporate Quality System Manual and GMP procedures by initiating and monitoring related training programs.
A higher Education degree is 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.
Experience implementing Lean Manufacturing and Six Sigma concepts is desired.
Attention to detail and the ability to work in a fast-paced environment are key.
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.
Ability to perform duties in both office and manufacturing environments.
Aortic regurgitation is different. So is our valve.
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System is the first and only device currently approved in the EU for the treatment of severe, symptomatic aortic regurgitation in patients that are deemed high-risk for surgical aortic valve replacement. The Trilogy System is also CE-Mark approved for treatment of severe, symptomatic aortic stenosis. In the US, JenaValve has completed enrollment of the ALIGN-AR IDE Clinical Trial which will support a future PMA submission. If approved, the Trilogy System would become the first and only TAVR system in the US indicated for the treatment of symptomatic, severe AR. JenaValve is headquartered in Irvine, California with offices in Leeds, U.K. and Munich, Germany.
Offices: 4 Cromwell, Suite 100, Irvine, CA 92618, US
