Boston Scientific is a global medical technology company that provides medical solutions to improve patient health. The Design Assurance Engineer I will support WATCHMAN projects within the Cardiology division, providing quality engineering support to digital application development and product development projects, ensuring compliance with regulatory requirements.
Support reviews of quality system deliverables, within JIRA and Windchill systems, for Digital Health (DH) and Software as a Medical Device (SaMD) products, developed in-house or with external vendors.
Collaborate with cross-functional teams (e.g., marketing, regulatory, legal, and software development) and external partners to create and review project or validation documentation (e.g., Software Intake Assessment, Software Validation Plan, etc.), ensuring compliance with Digital Health Quality System processes.
Working knowledge of IEC62304, IEC82304, and ISO14971 standards.
Collaborate globally with quality system stewards to enhance processes for digital health software development and compliance.
Working knowledge of Design Controls and Risk Management. Collaborate with a cross-functional team to identify and implement effective controls through an ongoing basis.
Provide quality and compliance input for product activities such as design changes, surveillance, design concessions, product CE marking and associated investigations: NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
Support internal and external regulatory submission, information requests and audits, as required.
Qualification
Required
Minimum of a Bachelors Degree
0-2 years of related work experience
Medical device regulated industry experience
Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent)
Working knowledge of IEC62304, IEC82304, and ISO14971 standards
Working knowledge of Design Controls and Risk Management
Preferred
Familiarity with digital applications and software as a Medical Device (SaMD) product experience
Self-motivated with a passion for solving problems and a bias for action
Focus on detailed work with emphasis on accuracy and completeness
Excellent organizational and planning skills; drives for results
Strong communication (oral and written) and presentation skills
High energy problem solver
Benefits
Boston Scientific is a global medical technology company that provides medical solutions to improve patient health.
