Job Description
Additional Location(s): US-MA-Marlborough; Ireland-Galway 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: The Design Quality Assurance Engineer II directly supports medical device product development from concept through commercialization. This individual will work with a high-performance cross-functional team to ensure the safety, quality, and compliance of our Endoscopy products. Provides quality engineering support as part of a new product development or sustaining team. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three days per week. We will also consider candidates based in our Galway, Ireland location. 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: Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, and Labeling). Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management. Apply sound, systematic problem-solving methodologies to resolve quality issues. Champion compliance to company policies, work instructions and SOPs. Support Post Market activities such as assessment of risk based on post-market signals, field assessments Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements. Lead the implementation of NCEP’s and CAPA’s while meeting or exceeding internal and external requirements Support internal and external regulatory audits as required. What we’re looking for in you: Required Qualifications Minimum of a bachelor’s degree in engineering Minimum of three years of experience in design assurance, new product development, or related medical device experience Ability to travel up to 15% (international and domestic) Ability to be onsite for a minimum of 3 days per week Preferred Qualifications: Master’s degree in engineering ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Demonstrated experience using Quality tools and methodologies Experienced in cross-functional collaboration and facilitating problem-solving Experience with design changes, complaint reduction, and corrective actions Strong communication (oral and written) and presentation skills. Requisition ID: 628284 Minimum Salary: $ 75100 Maximum Salary: $ 142600 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