Engineer II Software Quality

About the position

This position works out of our Westfield, IN location in the Structural Heart division. Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division.

Responsibilities

• Develop and conduct training of company personnel for the divisional software development and validation program.
• Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
• Create and execute or direct software validation protocols traceable to system/software requirements.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Assist in the completion and maintenance of risk analysis, focused on software related risks.
• Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
• Software scoping and Part 11 audits.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• Bachelors Degree (± 16 years) in Engineering or Technical Field or an equivalent combination of education and work experience.
• Minimum 2 years of Software Quality Engineering experience.
• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
• Advanced computer skills, including statistical/data analysis and report writing.
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred.
• ASQ CSQE certification desired.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally.

Benefits

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.