Senior Engineer I, THV Manufacturing

Jenavalve Technology; Irvine (CA); On-site; USD 85,320 - 104,280; Full time

Job summary

JenaValve in Irvine, CA is seeking a Senior Engineer for THV Manufacturing to sustain and optimize valve production lines. You will support manufacturing engineering tasks, develop processes, and create work instructions for transfer to manufacturing.

The role emphasizes GMP compliance, cross-functional collaboration with R&D and Quality, and driving continuous improvement on time and within budget. Experience in medical devices is required.

Qualifications

• Bachelor of Science in Mechanical or Biomedical Engineering.
• Minimum 4 years’ experience in Medical Device Development or Manufacturing.
• Knowledge of IQ/OQ/PQ in medical devices or regulated industries.
• Knowledge of SPC and sampling plans; ability to articulate results clearly.
• Six Sigma/Lean experience; Lean Six Sigma certification preferred.
• Work Instruction creation and implementation experience.

Responsibilities

• Provide real-time production line support with GEMBA walks, troubleshooting, daily meetings, and material review boards.
• Develop and optimize manufacturing processes to improve efficiency and quality using lean principles.
• Create training and documentation materials to transfer new products to manufacturing.
• Analyze data to identify opportunities; conduct CAPA investigations and determine root causes.
• Lead short- and long-term manufacturing process improvement projects.
• Support equipment, tooling, and fixture design for development and production.
• Document and manage non-standard build requests from R&D and Quality with end-to-end support.
• Perform process characterization and validation under guidance from senior staff.
• Address issues constructively and make risk-based decisions for quality and availability.
• Ensure compliance with GMP and regulatory standards across manufacturing.

Skills

Cross-functional collaboration

Project management

Attention to detail

Documentation

GMP compliance

SolidWorks

Interpersonal skills

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

Job Details

Job Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $94,800.00 - $94,800.00 SalaryJob Category: EngineeringJob Title: Senior Engineer, THV Manufacturing

Senior Engineer I, THV Manufacturing

Senior Engineer II, THV Manufacturing

Senior Engineer III, THV Manufacturing

Supervisor/Manager Title: Senior Global Manager, Manufacturing Engineering

Job Description Summary

Responsible for manufacturing engineering tasks associated with sustaining clinical/commercial valve (THV) production line.

Job Responsibilities

• Provide real-time production line support, such as daily GEMBA walks, equipment troubleshooting, daily tiered meetings, material review board.
• Develop and optimize manufacturing processes to increase efficiency and quality of products, using lean manufacturing engineering principles.
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless transfer of new product/processes to manufacturing.
• Generate, analyze and summarize data to identify improvement opportunities or to determine appropriate limits and variables for product and process. Perform Corrective and Preventative Action investigations to determine root causes for identified defects and/or trends.
• Lead short-term and long-term manufacturing process improvement activities/projects.
• Support equipment, tooling, and fixture design for development and production activities.
• Document and manage non-standard manufacturing build requests from cross-functional groups (R&D, Quality) on the production line; provide manufacturing engineering support from production planning, procedure redlines, operator training, through to completion of builds.
• Perform process characterization and validation, under the guidance of a project leader or more senior engineer.
• Confront issues in a constructive manner and at an appropriate organizational level and persevere in the face of adversity.
• Make risk-based decisions to ensure identified issues are assessed and resolved in a way that support JenaValve’s commitment to product quality, regulatory compliance and product availability.

Qualifications

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree).
• Minimum of 4 years’ experience in Medical Device Development or Manufacturing environment is required. Level I, II, II DOE.
• Knowledge of equipment and process qualification (IQ/OQ/PQ) in the medical device industry or other regulated industries is required.
• Knowledge of statistical process control and sampling plans is required. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
• Six Sigma and/or Lean Manufacturing experience required; Lean Six Sigma certification preferred.
• Knowledge and experience in Work Instruction creation and implementation.

Preferred Qualifications

• Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
• Experience in designing and implementing fixturing from design concept to a clinical/commercial production line.
• Experience in implementing equipment from parameter/settings origin to the production line.

Skills and Abilities Required for This Job

• Must be able to work effectively and collaborate within cross-functional teams.
• Must take initiative, communicate status and objectives and be able to conduct hands-on work.
• Effective communication and project management skills are required.
• Must be able to handle multiple tasks with high attention to detail.
• Must have strong documentation skills.
• Knowledge of and experience in compliance with GMP and Regulatory procedural standards in a medical device environment.
• Experience in the use of CAD packages (SolidWorks preferable).
• Strong interpersonal and intercultural skills are required.
• Ability to work across various time zones and to travel up to 10%.