Principal Design Quality Engineer - New Product Development

Additional Location(s): US-MN-Minnetonka; US-MA-Marlborough 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 Principal Design Quality Engineer will support the Valencia Technologies Integration project with a focus on New Product Development. This role is responsible for leading Design Assurance activities throughout the product development lifecycle, ensuring products and processes remain safe, effective, high quality, and compliant with Boston Scientific and global regulatory requirements. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work mode requiring employees to work onsite at least three days per week. This position is based in Minnetonka, MN or Marlborough, MA. Relocation Assistance Relocation assistance is available for this position. Visa Sponsorship Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position. Key Responsibilities Serve as the quality representative within cross-functional development teams, influencing project strategy, driving compliance to Design Control and Risk Management requirements, and ensuring alignment with regulatory and business objectives. Lead Design Assurance activities throughout product development for an active implantable technology. Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality-related issues. Author and maintain Design History File (DHF) documentation, including design inputs/outputs, technical rationales, verification/validation documentation, and risk management deliverables in compliance with internal and external requirements. Lead and support product risk management activities throughout the product lifecycle, including hazard analysis, fault tree analysis, FMEA, usability risk assessments, and post-market risk evaluation. Partner with R&D, Manufacturing, Regulatory, and other cross-functional teams to establish and implement Design Controls based on Risk Management, customer needs, and manufacturing inputs. Support verification, validation, and usability testing activities to ensure products meet internal requirements, regulatory expectations, and customer needs. Demonstrate strong working knowledge and application of validation methodologies, statistical techniques, and quality engineering principles. Collaborate effectively within a mixed onsite and remote working environment. Required Qualifications Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline. Minimum of 7+ years of experience in Design Assurance, Quality Engineering, New Product Development, or related medical device/regulated industry experience. Strong understanding of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and Design Control requirements for medical devices. Demonstrated experience applying Quality Engineering tools and methodologies. Strong verbal and written communication skills with the ability to influence across functions and levels. Demonstrated experience authoring and reviewing detailed technical documentation. Self-motivated with strong problem-solving skills and a bias for action. Ability to effectively collaborate in a hybrid onsite and remote work environment. Preferred Qualifications Experience working with active implantable medical devices and/or medical electrical equipment. Experience supporting acquisition integration and quality system harmonization activities. Experience supporting software development lifecycle activities in accordance with IEC 62304. Experience facilitating structured problem-solving methodologies and risk-based decision making. Experience supporting regulatory inspections and external audits. Adaptable and effective collaborator in both team-based and self-directed environments. Requisition ID: 629871 Minimum Salary: $ 102100 Maximum Salary: $ 194000 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.