Design Assurance Engineer
hace 2 meses
The Boston Scientific Corporation is seeking a highly skilled Design Assurance Engineer to join its team. This role will play a key part in ensuring the quality and safety of medical devices from concept to commercialization.
This individual will be responsible for assessing product performance, analyzing trends, and identifying areas for improvement. The successful candidate will also lead and communicate with cross-functional teams to implement complaint reduction and post-marketing projects.
The ideal candidate will have a Bachelor's or Licenciature degree in a relevant field, such as Chemical, Mechanical, Materials, or Biomedical Engineering. They will also possess excellent problem-solving and critical thinking skills, as well as the ability to work in a regulated environment and collaborate with clinical teams.
This role offers a unique opportunity to contribute to the development and launch of innovative medical devices that improve patient health and outcomes.
Responsibilities:
- Assess product performance and identify areas for improvement
- Lead and communicate with cross-functional teams to implement complaint reduction and post-marketing projects
- Guarantee compliance with Quality System Regulations, Corporate Quality Manual, and corporate and local standard operating procedures
- Develop and maintain safety risk management processes, including Hazard Analysis, Fault Tree Analysis, and Risk Management Plans
- Perform quality trending using complaint and NCEP/CAPA systems, and lead risk analyses for CAPA and/or audit findings investigations
- Assess changes to protect the design intent of a product to meet safety, efficacy, regulatory, and business requirements
- Support internal and external regulatory audits, as required
Requirements:
- Bachelor's or Licenciature degree in a relevant field
- Excellent problem-solving and critical thinking skills
- Ability to work in a regulated environment and collaborate with clinical teams
- Strong communication and leadership skills
Benefits:
- Competitive salary and benefits package
- Opportunities for career growth and professional development
- Collaborative and dynamic work environment
- Recognition and reward for outstanding performance
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