Boston Scientific is seeking a Software-focused Design Quality Engineer II to support the development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) division, aiming to solve important health industry challenges and ensure patient safety and business needs are met.
Requirements
- Understanding of Software Development Lifecycle (SDLC)
- Understanding of software testing and issue investigation/ resolution
- Understanding of software configuration management (version control, Microsoft office tools)
- Knowledge of analytical techniques, problem solving and process improvement
- Prior Software Design Assurance or related experience is a plus
- Medical device or other regulated industry experience
- Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
Responsibilities
- Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V
- Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
- 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).
- Participate in Cybersecurity related discussions and assist supporting activities
- Assist in the design and development of software test methods and inspection procedures.
Other
- Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device/regulated industry
- Strong written/verbal communication skills
- This role follows a hybrid work model requiring employees to be in our Maple Grove office at least three days per week.
- Relocation assistance is available for this position.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
