Senior Engineer I, THV Manufacturing

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA, seeks a Senior Engineer for THV Manufacturing to sustain and improve the THV production line.

You will provide hands-on manufacturing engineering support, develop and optimize processes, and create work instructions for transfer to manufacturing. The role requires a BS in Mechanical or Biomedical Engineering, 4+ years in medical devices, knowledge of IQ/OQ/PQ, GMP, Lean Six Sigma, and strong data analysis.

Qualifications

• BS in Mechanical or Biomedical Engineering required.
• Minimum of 4 years' experience in Medical Device Development or Manufacturing.
• Knowledge of IQ/OQ/PQ qualification methods.
• Experience with GMP and regulatory standards.
• Lean Six Sigma experience; certification preferred.

Responsibilities

• Provide real-time production line support and issue resolution.
• Develop and optimize manufacturing processes for efficiency and quality.
• Create training materials and work instructions for transfer to manufacturing.
• Analyze data to identify improvement opportunities and root causes.
• Lead process improvement initiatives and support equipment design.
• Document and manage non-standard build requests across groups.
• Perform process characterization and validation under guidance.
• Contribute to risk assessments and regulatory compliance.

Skills

Cross-functional collaboration

Project management

Documentation

GMP/regulatory compliance

CAD—SolidWorks

Communication

Multitasking

Attention to detail

Travel up to 10%

Education

BS in Mechanical or Biomedical Engineering

Tools

SolidWorks

IQ/OQ/PQ

Job description

Job Title: Senior Engineer, 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

Required Education and Experience

• 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%.