Senior System Design Quality Engineer

About the role

We have an exciting opportunity for a Senior System Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support an Imaging Guidance System, a significant product line with high visibility, which will provide the right candidate with excellent growth potential and product development experience.

Responsibilities

• Responsible for design control and risk management of next-generation medical devices
• International standards compliance, including ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304
• 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
• Led the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• 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)
• Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices

Requirements

• Bachelor’s degree in engineering or science discipline, or equivalent
• Minimum of 5 years experience in design assurance, quality, or related medical device or regulated industry experience
• ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304, CFRs, and Quality System Regulations understanding & demonstrated use
• Strong communication skills (verbal & written) and presentation skills
• Problem solver, capable of facilitating the problem-solving process & driving issues to closure
• Excellent organizational and planning skills; drives for results
• Adaptable and effective collaborator in a team environment and in self-directed work
• Focus on detailed work with emphasis on accuracy and completeness
• Experience with Class III Medical Devices

Qualifications

• Preferred Qualifications: Focus on detailed work with emphasis on accuracy and completeness Ability to collaborate and work on a highly matrixed and global team Experience with Class III Medical Devices