Principal Engineer, Quality

Overview

Job Title:

Principal Engineer, Quality

Supervisor/Manager

Title:

Director, Quality

Job Description

Summary:

Jena Valve Technology, Inc. designs, develops, and manufactures transcatheter aortic valve replacement (TAVR) systems comprising the implantable transcatheter heart valve (THV) and transfemoral delivery system.

Responsible for providing Quality Engineering technical leadership across product development and manufacturing programs, THV and delivery system.

• Train, coach, and guide lower-level employees on projects, procedures, and complex problem solving. Oversee Quality support tasks; instruct engineers/technicians on conducting tests; train engineers/technicians and provide feedback; and may coordinate engineers/technician work/tasks.
• Responsible for the quality engineering aspects of process development, risk management, qualification of equipment, qualification of the cleanroom, validation of processes, quality processes including receiving and in-process or final inspections, test method development, applicable software validations, and Supplier Quality requirements.
• Lead and actively support Risk Management activities including Hazard Analyses, Design/Process/Application Failure Mode and Effects Analyses (DFMEA, PMEA and AFMEA), Complaint Investigations and Product Evaluations, Risk-Benefit Analyses, and periodic Risk Management Reviews.
• Drive the development and manage the execution of experiments and tests (including protocol and report writing) to verify, validate, and improve products (including components and subassemblies) and manufacturing processes/methods based on sound engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion.
• Develop training and documentation materials (e.g., work instructions) to enable the effective knowledge transfer of project, manufacturing, and business processes to production. Proactively coordinate activities that require contributions across functions and geographic sites.
• Initiate and lead in the investigation of highly complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations); analyze results, make recommendations, and develop reports, based on engineering principles.
• Other responsibilities as determined by Management.
• Up to 30% travel may be required.

• Bachelor’s degree in Engineering with a minimum 10 years’ experience or Master’s degree plus 8 years’ experience in medical device engineering.
• ASQ Certified Quality Engineer (CQE) preferred.
• Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering.
• Experience in special manufacturing environmental controls for cardiovascular implantable devices, sterile device packaging, and process validation.
• Strong knowledge and understanding of US 21 CFR Part 820, EN ISO 13485:2016, ISO 14971:2019, and other International Standards.
• Expert problem-solving, organizational, analytical, and critical thinking skills.
• Knowledge of and adherence to cleanroom medical device hygiene and manufacturing best practices.
• Demonstrated experience in leading Design Control, manufacturing transfers, process verification and validation, equipment qualification and control in the medical device industry.

• Work independently with high attention to detail, and without close supervision.
• Effectively collaborate and communicate (verbal, written) within cross-functional teams.
• DMAIC and other problem solving and analytical skills. Strong knowledge of statistics and experience with application in medical device development and manufacturing environments required.
• Excellent documentation, communication, negotiating, interpersonal, and relationship management skills.
• Expert in quality systems, statistical techniques, and risk management.
• Serve as best practice/quality resource within Quality or as technical expert on functional or cross-functional teams or projects.
• Excellent presentation skills enabling representation of Quality considerations, requirements, data, and trends for regulatory agency meetings, customer visits, business meetings, or other company functions.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industries:
  Medical Equipment Manufacturing

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