Project Engineer, Quality Engineering

Overview

Our Client l is looking for a Project Engineer who will be contributing to the design, development, and manufacturability of neurovascular/ vascular products in accordance with the company's Quality System and customer requirements. The role is multifaceted and varied; it requires technical knowledge for assigned projects or products to ensure the design and development process is followed and will include but is not limited to design, development, verification, and validation testing, transfer to manufacturing, and continuous enhancements/ improvements to the products.

Project Engineering:
Develop detailed specifications, maintain product documentation (Design History File, Technical file), etc...

• Develop, execute, and report project verification validation activities in accordance with project plans.
• Support the development of design specifications to assure manufacturability.
• Provide Manufacturing Engineering expertise in the daily operation and maintenance of the assigned manufacturing processes and related business continuity needs in production and to contract manufacturers as needed. Troubleshoot manufacturing processes and equipment.
• Provide Engineering expertise to the design, fabrication, development, installation, validation, and qualification of equipment/fixtures per the Quality System requirement.
• Work with R&D and the Production team to manufacture products for Design Verification and to transfer new products and processes into a manufacturing environment.
• May be required to lead or contribute to the process of transferring the design from development to manufacturing.
• Ensure product documentation is in accordance with the Quality Management System requirements.
• May work directly with Q'Apel's customers to assure product design, user interface, and integration activities needed for products, and verification/validation testing.
• May be required to lead or contribute to the process of transferring the design into the manufacturing environment from development.
• Perform job functions in a safe and effective manner.
• Provide verification/validation testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies.
• Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements, and training requirements for the position. Communicate concerns involving product quality as needed.
• Other duties as assigned.

BS Degree in Engineering or related discipline or equivalent related experience in the medical device industry.

• 6 years minimum of experience in engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry.
• Knowledge of FDA regulations, guidelines, and policy statements.
• Knowledge of international regulations, standards, and guidelines (QSR, ISO 13485, Risk Management, Usability).
• Effective/ Excellent verbal and written communication.
• Project management experience and detailed project planning is desirable.
• Familiar with Design Control procedures and requirements.
• Ability to work independently or in a team setting required.
• Communicating effectively across all levels of the organization.
• Works well under pressure, is organized and self-motivated.
• Experience in sterile validation, aging studies, packaging validation, biocompatibility, RMF.
• Ability to work on multiple projects at any given time.
• Familiarity with ERP systems such as Netsuite is a plus.
• Proficient in MS Word, Excel, PowerPoint, and Project. CAD experience is a plus.
• Available to work from the office at our HQ location in Fremont.