Design Assurance Engineer III - Electrophysiology

Additional Location(s): N/A 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: We have an exciting opportunity for a Design Assurance Engineer III supporting new product development and sustaining activities for the cardiac mapping and ablation systems within the EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The Design Assurance Engineer III will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week. Relocation assistance Relocation assistance is not 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: * Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. * Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. * Maintains product risk management documentation (i.e. Hazard Analysis & FMEAs). * Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities. * Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. * Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc. * Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. * Able to navigate gray space by applying risk-based criteria to prioritize project work. * Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables. Required Qualifications: * Minimum of a bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study * Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience * ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis * Experience navigating design, manufacturing and/or supplier variations Preferred Qualifications: * Strong understanding of NCEP/CAPA processes * Previous experience working to create/maintain risk documentation such as FMEAs and HAs * Experience working with Stature or FMEA MED-8 software * Self-motivated with a passion for solving problems and a bias for action * Ability to manage multiple priorities and work with ambiguity * Strong communication skills (verbal & written) * Proficiency in collaborating with interdisciplinary teams * Familiar with EP environment Requisition ID: 629780 Minimum Salary: $ 82100 Maximum Salary: $ 156000 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), non-sales roles may 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 for exempt, non-sales roles may 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. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 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.