Job Information
Boston Scientific Design Assurance Engineer II in Maple Grove, 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: We have an exciting opportunity to join the Peripheral Interventions Design Assurance team supporting the TheraSphere device. This Design Assurance Engineer II will be dedicated to advancing the treatment of liver cancer, TheraSphere is a catheter-based, loco-regional radiation therapy. The Design Assurance Engineer II develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Design Assurance Engineer II will provide focused quality engineering support for sustaining and new product development to ensure the delivery of the highest quality product to the customer. Your key responsibilities will include: Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input. Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Actively support the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed. Monitor field performance of established medical devices against risk assessments in support of Post - Market activities. Analyze these data and identify areas of product design to proactively improve field performance. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Update and maintain Design History File, Design Input / Output, and Risk documentation. Acts as team member in supporting quality disciplines, decisions, and practices. Required Qualifications: Minimum of a Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field of study Minimum of 2 years of related experience Preferred Qualifications: Medical device experience Focus on detailed work with emphasis on accuracy and completeness Ability to collaborate with cross functional teams Strong communication (oral and written) and presentation skills High energy problem solver capable of driving items to closure Requisition ID:577292 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 in 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 imp oving 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