Senior Design Quality Assurance Engineer

Senior Design Quality Assurance Engineer

This is an exciting opportunity for a Senior Design Quality Assurance Engineer to join a cross-functional team on the new Renal Denervation business within BSC's Cardiology division. This position will support the significant new Renal Denervation acquisition integration and product development program 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 to support acquisition integration of product design, product development lifecycle and software development lifecycle activities. The Senior Design Assurance Engineer 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.

Your responsibilities will include:

• Work within a cross-functional, cross-site team to identify and implement effective controls to support product acquisition integration and product development from concept through commercialization.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices, providing quality and compliance input to project teams for project decisions and deliverables throughout total product lifecycle of the medical electrical equipment systems, including hardware, firmware and software.
• Participate in the implementation of new product design controls including risk management (per ISO 14971) for medical electrical equipment systems, including hardware, firmware and software.
• Support the execution and documentation of Design Verification, Design Validation, and Usability activities with a thorough understanding of medical electrical equipment, system engineering and software design controls.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including software bugs and/or field issues.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor's degree in Engineering, or related degree
• Minimum of five years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Understanding of Medical Electrical Equipment (MEE) Total Product Life Cycle
• Experience with hardware, firmware and system testing and associated issues investigation/resolution
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment
• Demonstrated use of Quality tools/methodologies

Preferred qualifications:

• Prior Software experience
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR, MDR), Risk Management standards (ISO 14971) and Cybersecurity requirements/guidance
• People management/supervision, coaching, mentoring experience

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.