Senior Software Design Assurance Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role: 
We have an exciting opportunity for Senior Software Design Assurance Engineer supporting software test activities for a Software As Medical Device (SaMD) product within Boston Scientific’s Interventional Oncology and Embolization portfolio.  In a hybrid work mode, the Senior Software Design Assurance Engineer will support software design, development, verification, validation, and maintenance throughout the full Software Development Lifecycle.  This position supports a major product category with high visibility which will provide the right candidate with excellent technical problem solving opportunity and  growth potential 

Your responsibilities include: 

• Representing the voice of quality within the product development team to ensure that design implementation meets the intent of product design while meeting quality standards and strategic business objectives.
• Develop and maintain understanding of the product/therapy space, including clinical use applications, to effectively integrate this knowledge with functional quality management system requirements.
• Application of Design Control and Risk Management processes throughout SDLC. Provide quality and compliance input to colleagues for project decisions and deliverables. 
• Creation, execution, and documentation of Software Design Validation & Verification activities such as protocols, test cases, reports, investigation and resolution of issues identified during test.
• Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Software Failure Mode and Effects Analysis. 
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Support internal and external regulatory audits as required.

What we’re looking for in you:
Required Qualifications:

• Bachelor’s degree in engineering or science discipline, or equivalent. 
• Minimum of 3 years experience in software test, software/product design assurance, quality, or related medical device or regulated industry experience
• Understanding and demonstrated use IEC 62304
• Strong communication skills (verbal & written) and presentation skills
• Problem solver, capable of facilitating the problem-solving process & driving issues to closure
• Excellent organizational and planning skills; drives for results 
• Travel approximately <10%

Preferred Qualifications:

• Used and understanding of ISO 13485, ISO 14971, CFRs, and Quality System Regulations 
• Experience in automated integration testing of Software as a Medical Device
• Prior exposure to risk management tools & methodologies such as hazard analysis, software FMEA on detailed work with emphasis on accuracy and completeness 
• Ability to collaborate and work on a highly matrixed and global team
• Experience with Class III Medical Devices
   

 

 

 

Requisition ID: 603343 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (s