Boston Scientific is looking for a Design Assurance Engineer II to develop, establish, and maintain quality engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role will provide quality engineering support within new product development, operational, or system/services support.
Requirements
- In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.
- Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
- Detailed understanding and experience with the IEC 60601-1 Medical Electrical Equipment Standard and/or supplemental standards.
- Experience working with medical equipment systems.
Responsibilities
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Other
- Bachelor’s Degree Mechanical, Electrical or Biomedical Engineering, or equivalent.
- Minimum of 3 years of experience
- Strong communication (oral and written) and presentation skills.
- Ability to collaborate and work on a global team.
- Must be able to work independently under limited supervision
