Senior Engineer I, THV Manufacturing

JENAVALVE TECHNOLOGY INC•Irvine, CA

1d•$94,800 - $94,800•Onsite

About The Position

Responsible for manufacturing engineering tasks associated with sustaining clinical/commercial valve (THV) production line.

Requirements

A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree).
Minimum of 4 years’ experience in Medical Device Development or Manufacturing environment is required.
Knowledge of equipment and process qualification (IQ/OQ/PQ) in the medical device industry or other regulated industries is required.
Knowledge of statistical process control and sampling plans is required.
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Six Sigma and/or Lean Manufacturing experience required.
Knowledge and experience in Work Instruction creation and implementation.
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

Lean Six Sigma certification preferred.
Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
Experience in designing and implementing fixturing from design concept to a clinical/commercial production line.
Experience in implementing equipment from parameter/settings origin to the production line.
Experience in the use of CAD packages (SolidWorks preferable).
Ability to work across various time zones and to travel up to 10%.

Responsibilities

Provide real-time production line support, such as daily GEMBA walks, equipment troubleshooting, daily tiered meetings, material review board.
Develop and optimize manufacturing processes to increase efficiency and quality of products, using lean manufacturing engineering principles.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless transfer of new product/processes to manufacturing.
Generate, analyze and summarize data to identify improvement opportunities or to determine appropriate limits and variables for product and process.
Perform Corrective and Preventative Action investigations to determine root causes for identified defects and/or trends.
Lead short-term and long-term manufacturing process improvement activities/projects.
Support equipment, tooling, and fixture design for development and production activities.
Document and manage non-standard manufacturing build requests from cross-functional groups (R&D, Quality) on the production line; provide manufacturing engineering support from production planning, procedure redlines, operator training, through to completion of builds.
Perform process characterization and validation, under the guidance of a project leader or more senior engineer.
Confront issues in a constructive manner and at an appropriate organizational level and persevere in the face of adversity.
Make risk-based decisions to ensure identified issues are assessed and resolved in a way that support JenaValve’s commitment to product quality, regulatory compliance and product availability.