Senior Software Design Assurance Engineer

The Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software.   The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience. 

• Provides technical and quality system guides related to establishing software requirements.
• Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures.  This includes, but is not limited to, reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation.
• Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development.
• Leads risk evaluation and associated management activities related to software development, including Risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues. 
• Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met.  Represent the quality engineering function for the review and approval of designated design outputs.    
• Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required. 
• May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
• Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures. 
• Maintains a strong, collaborative partnership with cross-functional team members, especially with R&D.
• Works as an individual contributor and may provide guidance or oversee the work of other QE team members.
• Develop and conduct training of company personnel for the divisional software development and validation program.
• Support audits and lead quality system improvement activities.
• Additional responsibilities may be assigned as needed.

• Bachelor’s degree in engineering or a technical field
• Minimum of 5 years related work experience in Quality or a related field.
• Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development. 

•  Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. 

• Advanced degree
• Previous quality engineering experience and demonstrated use of quality tools/methodologies.   
• Experience working in a broader enterprise/cross-division business unit model. 

Apply Now