Staff Engineer I, Medical Device Manufacturing

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA seeks a Staff Engineer, THV Manufacturing to bridge R&D and commercial manufacturing, driving valve product life cycle from early use to commercialization and optimizing manufacturing processes.

The role focuses on developing and validating critical processes, leading cross-functional teams, and delivering robust, scalable manufacturing solutions for THV devices.

Qualifications

• Bachelor of Science in Mechanical or Biomedical Engineering required.
• Master of Science in Engineering preferred.
• Minimum 6+ years in Medical Device Development or Manufacturing environment.
• Knowledge of equipment qualification and design verification, process validation in the medical device industry or other regulated industries is required.
• Understanding of statistical techniques is required and must be able to articulate results to technical and non-technical personnel.

Responsibilities

• Provide technical engineering support for THV devices to ensure processes are characterized and scaled up using new technology and standard work.
• Collaborate with Quality and R&D to develop and validate critical processes; lead opportunities to optimize manufacturing processes using engineering methods (Six Sigma/Lean).
• Develop training and documentation materials for production to enable knowledge transfer of projects.
• Support equipment, tooling, and fixture design for Development and Operations, including cost assessment and improvements.
• Provide technical quality support for design qualifications, design transfer, regulatory submissions, and change control.
• Analyze and resolve medium to complex Manufacturing and Compliance issues (CAPA, non-conformances, audits).
• Execute manufacturing support tasks; instruct engineers/technicians; train and provide feedback.
• Train, coach, and guide lower-level employees on procedures.
• Lead medium to complex project plans with project management tools (e.g., Project Plan, Risk Analysis).
• Drive development and execution of complex experiments and tests to qualify and validate processes; analyze results and report.
• Provide technical management of Development and Manufacturing-related team projects.

Skills

Initiative

Cross-functional teams

Communication

Project management

Documentation

GMP compliance

Regulatory knowledge

Multitasking

Intercultural skills

Education

B.S. in Mechanical or Biomedical Engineering

M.S. in Engineering preferred

6+ years in Medical Device Development or Manufacturing

Equipment qualification and design verification experience

Statistical techniques knowledge

Job description

JenaValve Technology, Inc. in Irvine, CA seeks a Staff Engineer, THV Manufacturing to bridge R&D and commercial manufacturing, driving valve product life cycle from early use to commercialization and optimizing manufacturing processes.

The role focuses on developing and validating critical processes, leading cross-functional teams, and delivering robust, scalable manufacturing solutions for THV devices.