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Über
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 Design Quality Engineer III 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 offered for this position at this time. Your responsibilities include: Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints) Work within a cross-functional team to identify and implement effective controls and support product development through commercialization. Support regulatory submissions to notified bodies. Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process. Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team 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 in you: Required Qualifications: Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent. Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience Some experience in new product development: e.g. creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), design verification 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) and presentation skills Ability to travel up to 10% Preferred Qualifications: Experience in developing test methods Experience supporting clinical trials Self-motivated with a passion for solving problems and a bias for action. Focus on detailed work with emphasis on accuracy and completeness 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
Sprachkenntnisse
- English
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