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Design Assurance Engineer III - ElectrophysiologyBoston Scientific Gruppe • Waltham, Massachusetts, United States
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Design Assurance Engineer III - Electrophysiology

Boston Scientific Gruppe
  • US
    Waltham, Massachusetts, United States
  • US
    Waltham, Massachusetts, United States
Jetzt Bewerben

Über

Design Assurance Engineer III – Electrophysiology Onsite Location(s): Waltham, MA, US 02138 About the role We have an exciting opportunity for a Design Assurance Engineer III supporting new product development and sustaining activities for the cardiac mapping and ablation systems within the EP division. This position supports several product categories with high visibility and will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The Design Assurance Engineer III will work with a high‑performance cross‑functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer. Work Mode This role follows a hybrid work model requiring employees to be in our local office three days per week. Relocation Assistance Relocation assistance is not available for this position at this time. Visa Sponsorship Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Responsibilities Work cross‑functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. Lead or support the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. Maintain product risk management documentation (i.e., Hazard Analysis & FMEAs). Lead or support the development of and coordinate the execution and documentation of Design Validation and Verification activities. Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Support and lead the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc. Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards. Navigate gray space by applying risk‑based criteria to prioritize project work. Support cross‑functional team through product life cycle process; specifically, with respect to design control and risk management deliverables. Required Qualifications Minimum of a bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study. Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience. ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. Experience navigating design, manufacturing and/or supplier variations. Preferred Qualifications Strong understanding of NCEP/CAPA processes. Previous experience working to create/maintain risk documentation such as FMEAs and HAs. Experience working with Stature or FMEA MED‑8 software. Self‑motivated with a passion for solving problems and a bias for action. Ability to manage multiple priorities and work with ambiguity. Proficiency in collaborating with interdisciplinary teams. Familiar with EP environment. Compensation Minimum Salary: $82,100 –
Maximum Salary: $156,000. Equal Opportunity Employer 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.
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  • Waltham, Massachusetts, United States

Sprachkenntnisse

  • English
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