Design Quality Assurance Engineer II, Renal Denervation
About The Position
This is an exciting opportunity for a Design Quality Assurance Engineer II 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 programs with high visibility, which will provide the right candidate with excellent growth potential, acquisition integration experience, and broad perspective in the medical device industry. The engineer will provide quality engineering support to acquisition integration, product development and sustaining projects for current clinical products and future commercial products. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Design Quality Engineer II will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals. At Boston Scientific, we value collaboration and synergy. This role requires employees to be in our Arbor Lakes 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.
Requirements
- 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.
- ISO 13485/ Quality System Regulations, ISO 14971/Risk Management understanding
- Strong communication skills (verbal & written) and presentation skills
Nice To Haves
- Medical Electrical Equipment, Cybersecurity and Software design controls understanding
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
