Senior Quality Engineer
: Job Details :

Job Description:

• Collaborate with a cross-functional design team to develop Client cardiovascular device/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance with applicable internal and external requirements.
• In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate the successful transfer/launching of robust products.
• This position provides an opportunity to work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
• Lead Risk Management process for the project in compliance with appropriate external standards and corporate policies, to ensure critical quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971.
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities. Strong leadership and collaboration with other leaders in the project and across the organization.
• Mentor engineers in the understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.).
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem-solving tools.
• Support Quality Engineering activities to improve customer satisfaction and the achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
• Train, coach, and guide lower-level employees on more complex procedures.
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/technicians' work.

Responsibilities:

• In-depth knowledge of Design Control, Risk Management, and related standards, as applicable for medical devices.
• Knowledge of Quality Engineering and Six Sigma concepts with the ability to apply to work product.
• Strong technical and analytical engineering skills.
• ble to understand drawings and device design at a practical level.
• Excellent verbal and written communication skills.
• ble to communicate clearly and concisely yet thoroughly.
• Strong leadership skills and ability to influence change.
• bility to handle multiple tasks simultaneously.
• Must be accurate in handling detailed information/data.
• Experience in early human use of NPD strongly preferred.
• Experience in Design for Manufacturing (DFM) preferred.
• Certified Six Sigma Black belt / CQE preferred.
• Experience with electronic devices, data transmission/acquisition a plus.
• Microsoft Office, Minitab.
• NPD experience as Quality/Design Assurance in Early Human Use, ISO 13485, ISO 14971.
• Experience in early medical device development as Design Assurance/Quality Engineer, results-driven, flexible and critical thinking.
• Design control in medical devices, NPD Quality Assurance, Risk Management.
• Design Six Sigma, ISO 14971, Early Human Use.

Requirements:

• Bachelor's Degree or equivalent in Engineering with 4 years of related industry experience OR master's degree in engineering with 3 years of related industry experience.