Job Information
Boston Scientific Principal Design Assurance Engineer in Arden Hills, Minnesota
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: The Principal Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization.This engineer will serve as a quality representative on a high-performing cross-functional and cross- divisional product development team on a major product category. This high visibility position provides the right candidate with excellent growth potential. Your responsibilities will include: Learn, use, and teach the most effective engineering tools to optimize designs of systems - Design Failure Modes and Effects Analysis (DFMEA), Benchmarking, Design of Experiments (DOE), Highly Accelerated Life Testing (HALT), Tolerance Stack Up Analysis, Engineering Statistics, and Weibull Analysis. This position is a technical, engineering job. Learn differences in divisional Quality Systems and Tools and apply them to product development or to design change process. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Serve as an effective quality leader or team member on a cross-functional product development team. Owns and drives deliverables related to Design Controls, Product Performance, Quality, and Compliance for cross divisional product. Develops and implements quality strategies; seeks innovative approaches to attain quality goals. Review and approve quality records, including product specifications, design verification test protocols, design verification test reports. Maintains and enhances cross-functional team relationships. Directly interfaces with internal and external audit activities. Required qualifications: Bachelor's degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline 6 years of experience in design assurance, post-market quality, or R&D engineering Strong mechanical and electrical aptitude Experience writing specifications, test protocols, and technical reports. Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, 5 Why's. Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics. Experience with mechanical and electrical test and measurement equipment. Preferred qualifications: Bachelor's degree and 9+ years or Master's degree with 6+ years of experience in design assurance, post-market quality, or R&D engineering Experience in design engineering or process development, including design optimization, process validation, and continuation engineering, Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA). Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. Experience with Active Implantable Medical Devices. Adaptable and effective collaborator in a team environment or in self-directed work. Requisition ID:579354 Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. As a leader i medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. 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. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran