Lead Design Assurance Specialist
3 weeks ago
About the Opportunity
Boston Scientific is a global leader in medical science, committed to solving challenges that matter most. We're united by a deep caring for human life and are dedicated to advancing science for life. Our mission is to create innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities we operate in.
As a Senior Design Assurance Engineer, you will work closely with new product development and product lifecycle teams to ensure adequate design controls are met and subsequent production and process controls are adequate. This role requires strong analytical and communication skills, as well as excellent organization and time management skills.
Key Responsibilities
- Responsible for design control and risk management of novel electrophysiology devices.
- Uses clinical knowledge to influence how devices are tested and designed.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Develops, directs, and executes plans for design control and risk management of complex projects.
- Loves the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
- Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team.
- Promotes and influences compliance to Boston Scientific's quality, business, and health & safety systems and market/legal regulations.
- Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Comply with the Health & Safety policies of the company and inform management of unsafe working conditions.
- Other duties as required.
Requirements
- Bachelor's Degree in Engineering (Mechanical, Biomedical preferred)
- 5+ years related working experience in the medical device industry
- Knowledge of ISO 13485, ISO 14971, IEC 62366-1
- Experience with design controls, design inputs and outputs, and risk mitigation activities
- Excellent analytical and communication skills (written and oral)
- Excellent organization and time management skills
- Interest in biomedical or health-related industry
Preferred Qualifications
- 2+ years of experience directly in a Design Assurance role
Salary
We offer a competitive salary of $120,000 per year, based on experience.
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