Staff Engineer, Medical Device Manufacturing

Jenavalve Technology Inc; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Jenavalve Technology Inc. seeks a Staff Engineer, THV Manufacturing in Irvine, CA. You will serve as the main interface between R&D and commercial manufacturing, guiding valve product lifecycle from development to commercialization.

You will lead process development, qualify equipment, and drive continuous improvement using Six Sigma and LEAN. Strong collaboration with Quality, Regulatory, and Operations is required; travel up to 20%.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering required; MS preferred.
• Minimum 6+ years in Medical Device development or manufacturing.
• Knowledge of equipment qualification and design verification; process validation.
• Strong statistical skills and ability to communicate results clearly.
• GMP and regulatory standards in medical devices knowledge.

Responsibilities

• Provide technical engineering support to scale up THV manufacturing processes.
• Partner with Quality and R&D to validate critical processes.
• Identify opportunities to optimize processes using Six Sigma and LEAN.
• Develop training materials and work Instructions for production.
• Design equipment, tooling, and fixtures for development and operations.
• Lead complex projects with schedules and risk analyses.
• Coach junior engineers; address CAPA, non-conformances, audits.

Skills

Six Sigma

Lean Manufacturing

Project Management

Statistical analysis

GMP compliance

Cross-functional collaboration

Documentation skills

Hands-on engineering

Multinational coordination

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Master of Science in Engineering

Job description

Jenavalve Technology Inc. seeks a Staff Engineer, THV Manufacturing in Irvine, CA. You will serve as the main interface between R&D and commercial manufacturing, guiding valve product lifecycle from development to commercialization.

You will lead process development, qualify equipment, and drive continuous improvement using Six Sigma and LEAN. Strong collaboration with Quality, Regulatory, and Operations is required; travel up to 20%.