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Senior Design Assurance Engineer
2 months ago
At Boston Scientific, we're driven by a passion for medical innovation and a commitment to delivering life-changing solutions. Our team of experts works tirelessly to develop cutting-edge technologies that improve patient lives and create value for our customers.
We're seeking a highly skilled Senior Design Assurance Engineer to join our Design Assurance Quality team. In this role, you'll work closely with new product development and product life cycle teams to ensure adequate design controls are met and subsequent production and process controls are adequate.
Your Key Responsibilities- Develop and implement design control and risk management strategies for novel electrophysiology devices.
- Collaborate with cross-functional teams to ensure devices meet clinical and regulatory requirements.
- Apply sound problem-solving methodologies to identify, prioritize, and resolve quality issues.
- Lead the implementation and development of product risk management tools, such as Hazard Analysis and Fault Tree.
- Demonstrate expertise in validation and statistical techniques to comply with regulatory requirements.
- Foster a culture of quality-centric patient care and customer satisfaction within the New Product Development team.
- Promote compliance to BSC's quality, business, and health & safety systems and market/legal regulations.
As a successful candidate, you'll possess a Bachelor's Degree in Engineering (Mechanical or Biomedical preferred) and 5+ years of relevant work experience. Your knowledge of ISO 13485, ISO 14971, IEC 62366-1 is essential, as is your experience with design controls, design inputs and outputs, and risk mitigation activities.
Our ideal candidate will have excellent analytical and communication skills, both written and oral, as well as strong organization and time management skills. If you're passionate about biomedical or health-related industry and want to make a meaningful difference, we encourage you to apply.
Estimated Salary: $120,000 - $150,000 per year, depending on location and experience.
