Staff Engineer I, THV Manufacturing (2nd Shift)

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

Job Title

Staff Engineer, THV Manufacturing

• Staff Engineer I, THV Manufacturing
• Staff Engineer II, THV Manufacturing
• Staff Engineer III, THV Manufacturing

Role Level

Individual Contributor

Supervisor/Manager Title

Senior Global Manager, Manufacturing Engineer

Job Location & Environment

Irvine, CA

Job Description Summary

The Staff Engineer, THV Manufacturing will serve as a main interface between R&D and commercial manufacturing, contribute to the THV valve product life cycle from Early Human Use to commercialization, and the development of new or optimized manufacturing processes.

Job Responsibilities

• Technical engineering support for THV devices to ensure processes are characterized and scaled up by utilizing new technology and standard work.
• Partner with Quality and R&D Engineers to develop and validate critical processes in the Development and Operations environment. Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to redesign/design of and ensure equipment, tools, fixtures, etc. are up to standards.
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Equipment, tooling and fixture design support and selection for Development and Operations activities, including cost assessment, cost reductions and product reliability improvement.
• Technical quality support for design qualifications, design transfer, activities for Regulatory submissions, product and process development and implementation of design control documents, and approval of product/process change.
• Analyze and resolve medium to complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Execute manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work.
• Train, coach, and guide lower-level employees on critical procedures.
• Lead and establish medium to complex project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Technical management of Development and Manufacturing-related team projects.

Qualifications

Required Education and Experience

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Master of Science degree in Engineering preferred.
• Minimum of 6+ years' experience in Medical Device Development or Manufacturing environment is required. Level I, II, III DOE.
• 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 effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.

Preferred Qualifications

• Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
• Project Management Certification.
• Six Sigma Green Belt and/or Lean Mfg Certification.

Skills And Abilities Required For This Job

• Must be able to take initiative, report activities to supervisor and have the ability to conduct hands-on work with minimal leadership.
• 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
• Strong interpersonal and intercultural skills are required.
• Ability to work across various time zones and to travel up to 20%.