Join our Structural Heart Group as a design assurance engineer (quality engineer) on new product development projects for the transcatheter valve program. Provide focused quality engineering support to the cross-functional valve engineering design team in order achieve commercial product launch. You will be responsible for supporting design goals for device reliability, valve durability, valve hemodynamic performance, customer needs, business timelines, and manufacturability. Individual will also develop, establish, and maintain quality engineering methodologies, design control systems, and practices which meet BSC, customer, and regulatory requirements.
Specific Duties and Responsibilities:
Determine device requirements for new product development valve projects.
Develop test methods confirming safety, efficacy and reliability of valve designs, including next generation technology.
Actively promote and participate in a cross-functional team environment.
Develop and coordinate the execution and documentation of Design Validation and Verification activities to confirm design and to support regulatory submissions to Notified Bodies and FDA.
Participate in the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Support the determination and implementation of Design controls based on Risk Management, Customer Needs and Manufacturing Input.
Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Perform regulatory standard assessments and support regulatory submissions to notified bodies.
Support the Design Control System during audit activities.
Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
Plans, organizes, and prioritizes own daily work routine to meet established schedule and provides guidance to less experienced staff.
· BS/BA in Mechanical or Biomedical Engineering Required ·
3-5 years of new product development experience, preferably in a quality role
· Surgical or transcatheter valve experience is preferred
· Medical device experience is required
· Strong written/verbal communication skills
· Demonstrated used of Quality tools/methodologies
· Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)
· Able to work well in a team environment with peer group
The majority of the work will be spent on-site (less than 10% travel) including testing labs and manufacturing environments.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.