Boston Scientific is looking to integrate a new Renal Denervation business acquisition and develop new products within their Cardiology division. This role will support the acquisition integration and product development lifecycle, requiring expertise in design controls, risk management, and quality assurance to ensure patient safety and meet business needs.
Requirements
- Experience with hardware, firmware and system testing and associated issues investigation/resolution
- Prior Software experience
- Strong knowledge of Quality System Regulation (QSR, MDR), Risk Management standards (ISO 14971) and Cybersecurity requirements/guidance
Responsibilities
- 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.
Other
- This role requires employees to be in our Arbor Lakes, MN office four days per week.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
- Minimum of 5 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
- 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
- People management/supervision, coaching, mentoring experience
