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Responsible for program/application/product development supporting business objectives while providing expertise in all phases of development lifecycle: conception, design, testing, production, and maintenance. Analyses, designs and builds using design patterns and systematic approaches. Works on new and existing programs/applications/products. Performs hands-on development, mentors junior developers, and assists in architecting and engineering solutions. Serves as liaison to internal customers, research groups and various business support areas. This person will work with other engineers and contract manufacturers to achieve project milestones including, but not limited to, design verification testing, regulatory submission and product launch of initial concepts and future iterations of the product.

 Key Job Responsibilities

• Functions as the single point of contact to a cross-functional team.
• Responsible for the development and delivery lifecycle during the following phases: 
  • Requirement Assessment: Works with inter-departmental teams to analyze and understand business requirements. Provides technical expertise during the requirements-gathering phase of a project. Accurately documents new requirements, enhancements to existing functionality, and implementation deficiencies that need to be addressed.
  • Development: Based on requirements, develops functionality by following internal development standards. The technical solution includes detailed design documentation, code, configuration, and other supporting technical documents. 
  • Testing: Performs unit, regression, connectivity and full end-to-end integration tests, when it applies; Supports quality insurance effort to gain user acceptance. 
  • Delivery: Works collaboratively with inter-departmental and cross-departmental resources to migrate new or enhanced functionality from test to production. Provides effective communication across the team as appropriate. Follows change control standards and processes for release to production. 
• Functions as a liaison with end users, research groups and other business support areas
• Leads the design and development of a program/application/product
• Facilitates design and technical meetings. Provides technical documentation to internal business and design teams
• Instructs, guides and mentors junior-level staff
• Provides support during special events such as mission-critical upgrades/enhancements, upgrades, new go-lives
• Develops and implements policies for security and confidentiality of program/application/product
• Provides support in the role of a backup to other members of the team
• Performs other duties as assigned or required by management
• Responsible for the mechanical design, development, and testing of a transcatheter heart valve and related accessory components for the treatment of aortic stenosis. 

• Bachelor's degree in Computer Science, Mathematics, Engineering, or related discipline required.
• Masters Degree in Engineering or similar field preferre

Licenses:

AWS Certified Solutions Architect - Associate    AWS Certified Solution Architect Associate, or AWS Certified Developer Associate, or similar.

Experience:

• 4-5 years of experience managing design, development, and maintenance in a complex, multiplatform environment required.
• 10 years' experience developing structural heart products and/or product design preferred 
• 10 Years' experience using 3D model software preferred
• Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO 14971, and ISO 62304 standards.
• Ability to use structural finite element analysis software such as Cosmos or Ansys.
• Demonstrate data analysis skills and sound statistical analysis methodologies to prepare data for regulatory review (Minitab, JMP or MedStat).