Responsible for design control and risk management of novel electrophysiology devices.
Uses clinical knowledge to influence how devices they are working on are tested and designed
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
Leads 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 BSC’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.
Required qualifications:
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