Senior System Design Quality Engineer
About The Position
We have an exciting opportunity for 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. This role will apply the directives of design controls, software development lifecycle (SDLC), risk management, product development, regulatory and standards compliance, compliance, corrective and preventive actions, improvements for manufacturability, and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
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
- Ability to work in a highly matrixed and geographically diverse business environment as the product expands Globally.
- Demonstrated use of Quality tools/methodologies
Nice To Haves
- 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
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
- Leads 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
- Participates in the implementation of product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
