Staff Engineer I, THV Manufacturing (2nd Shift)

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

Job Details: Job Location: Irvine, CA 92618, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $125,600.00 - $125,600.00 Salary, 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 re-design/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 customer’s 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%.