About
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 Senior Design Assurance (DA) Engineer supporting WATCHMAN new product development projects within BSC's Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and new product development experience. In this position you will work with a Design Assurance and cross-functional team to support medical device product development from concept through commercialization and maintain the design control and risk analysis files. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN at our Weaver Lake Campus and requires being on-site at least three days per week. Relocation assistance is available for this position at this time. Visa sponsorship is not available for this position at this time. Your Responsibilities Include:
In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams. Support the execution and documentation of Design Validation & Verification and Usability activities. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications). Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs). Lead and support cross-functional root-cause analysis investigation and resolution activities Support regulatory submissions to notified bodies. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. What We're Looking For:
Required Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use Excellent organizational and planning skills; drives for results Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies Ability to travel up to 10% Preferred Qualifications: Experience in developing test methods Experience supporting clinical trials Problem solver, capable of facilitating the problem-solving process Adaptable and effective collaborator in a team environment and in self-directed work Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups. Experience with Class III Medical Devices Refer to ID 85766844 when applying
Languages
- English
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