Senior System Design Quality Engineer

Senior System Design Quality EngineerAt 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 System Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support an Imaging Guidance System, a significant product line with high visibility, which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls, software development lifecycle (SDLC), risk management, product development, regulatory and standards compliance, compliance, corrective and preventive actions, improvements for manufacturability, and cost-reduction efforts.They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three days per week.Relocation assistance:Relocation assistance may be available for this position at this time.Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities include:Responsible for design control and risk management of next-generation medical devicesInternational standards compliance, including ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304.Uses clinical knowledge to influence how devices they are working on are tested and designedApplies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesIndependently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projectsLeads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulationsProvides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development groupParticipates in the implementation of product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&VActs as an effective leader or team member in supporting quality disciplines, decisions, and practices.What we're looking for in you:Bachelor's degree in engineering or science discipline, or equivalent.Minimum of 5 years experience in design assurance, quality, or related medical device or regulated industry experienceISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304, CFRs, and Quality System Regulations understanding & demonstrated useStrong communication skills (verbal & written) and presentation skillsProblem solver, capable of facilitating the problem-solving process & driving issues to closureExcellent organizational and planning skills; drives for resultsAdaptable and effective collaborator in a team environment and in self-directed workAbility to work in a highly matrixed and geographically diverse business environment as the product expands Globally.Demonstrated use of Quality tools/methodologiesFocus on detailed work with emphasis on accuracy and completenessAbility to collaborate and work on a highly matrixed and global teamExperience with Class III Medical Devices