Boston Scientific Software Design Assurance Engineer III 

United States, Minnesota 

655050811

Your Responsibilities include:

• • Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, and software design V&V
  • Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
  • Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
  • Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs).
  • Lead and participate in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Participate in Cybersecurity related discussions and assist supporting activities
  • Assist in the design and development of software test cases and inspection procedures.
  • Support regulatory submissions to notified bodies.
  • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we’re looking for in you:

Required Qualifications

• Bachelor’s degree in Engineering, or related discipline
• A minimum of 3 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience or 2 years of experience with an advanced relevant degree
• Understanding of Software Development Life Cycle (SDLC)
• Experience with software testing and issue investigation/resolution
• Experience with Issue Tracking Tools and requirements / test management tools
• Understanding of software configuration management (version control, Microsoft office tools)
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment
• Demonstrated use of Quality tools/methodologies

Preferred Qualifications

• Experience with Software integration with electro-mechanical devices
• Prior Software Design Assurance or Software R&D experience
• Medical device or other regulated industry experience
• Understanding of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)

Maximum Salary: $ 144400

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.