Staff Engineer I, THV Manufacturing (2nd Shift)

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

Job Title: Staff Engineer, THV ManufacturingStaff Engineer I, THV ManufacturingStaff Engineer II, THV ManufacturingStaff Engineer III, THV ManufacturingRole Level: Individual ContributorSupervisor/Manager Title: Senior Global Manager, Manufacturing EngineerJob Location & Environment: Irvine, CAJob 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.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 environmentStrong interpersonal and intercultural skills are required.Ability to work across various time zones and to travel up to 20%.