Boston Scientific is looking to solve health industry challenges, specifically in the Renal Denervation business within the Cardiology division, by integrating new acquisitions and developing products that meet regulatory requirements.
Requirements
- ISO 13485/ Quality System Regulations, ISO 14971/Risk Management understanding
- Medical Electrical Equipment, Cybersecurity and Software design controls understanding
- Strong communication skills (verbal & written) and presentation skills
- Focus on detailed work with emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- High energy problem solver capable of driving items to closure
- Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.
Responsibilities
- Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
- Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
- Support regulatory submissions to notified bodies.
- Develop, update, and maintain product and/or software risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
- Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
- Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team
Other
- Bachelors Degree in Engineering (preferably in Mechanical, Electrical or Biomedical) or related degree.
- Minimum of 3 years of experience in design assurance, quality, or related regulated industry experience
- Self-motivated with a passion for solving problems and a bias for action.
- Must be in the 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.
