Staff Engineer I, THV Manufacturing (2nd Shift)

JENAVALVE TECHNOLOGY INC•Irvine, CA

20d•$125,600 - $125,600•Onsite

About The Position

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.

Requirements

A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
Minimum of 6+ years’ experience in Medical Device Development or Manufacturing environment is required.
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.
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.

Nice To Haves

Master of Science degree in Engineering preferred.
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.

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.