Staff Engineer, Medical Device Manufacturing

Jenavalve Technology; Irvine (CA); On-site; USD 113,000 - 138,000; Full time

Job summary

Jenavalve Technology in Irvine, CA is seeking a Staff Engineer, THV Manufacturing. You will serve as the main interface between R&D and commercial manufacturing, contributing to the valve product lifecycle from early human use to commercialization.

The role requires a Bachelor of Science in Mechanical or Biomedical Engineering, 6+ years in medical device development or manufacturing, and knowledge of GMP, process validation, and LEAN/Six Sigma methods. Travel up to 20% may be required.

Qualifications

• Bachelor of Science in Mechanical or Biomedical Engineering required.
• Master of Science in Engineering preferred.
• Minimum 6+ years’ experience in Medical Device Development or Manufacturing.
• Knowledge of equipment qualification, design verification, and process validation in medical devices or regulated industries.
• Understanding of statistical techniques and ability to articulate results clearly.

Responsibilities

• Provide technical engineering support to ensure processes are characterized and scaled up using new technology and standard work.
• Collaborate with Quality and R&D to develop/validate critical processes; drive optimization with Six Sigma/LEAN.
• Develop training materials and work instructions for production to enable knowledge transfer.
• Support equipment/tooling/fixture design, cost assessment, and reliability improvements.
• Support design qualifications, design transfer, regulatory submissions, and change control activities.
• Analyze and resolve manufacturing/compliance issues (CAPA, non-conformances, audits).
• Lead and coordinate project plans and guide junior staff in critical procedures.
• Conduct experiments and tests to qualify manufacturing processes and generate reports.

Skills

Initiative

Collaboration

Communication

Documentation

Time management

Attention to detail

GMP compliance

Education

B.S. in Mechanical or Biomedical Engineering

M.S. in Engineering preferred

Job description

Jenavalve Technology in Irvine, CA is seeking a Staff Engineer, THV Manufacturing. You will serve as the main interface between R&D and commercial manufacturing, contributing to the valve product lifecycle from early human use to commercialization.

The role requires a Bachelor of Science in Mechanical or Biomedical Engineering, 6+ years in medical device development or manufacturing, and knowledge of GMP, process validation, and LEAN/Six Sigma methods. Travel up to 20% may be required.