Design Quality Assurance Engineer III, Renal Denervation

Design Quality Assurance Engineer III, Renal Denervation

Work mode: Onsite

Onsite Location(s): Maple Grove, MN, US, 55311

About the Role:

This is an exciting opportunity for a Design Quality Assurance Engineer III 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 III 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.

Your Responsibilities Will Include:

• 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

Required Qualifications:

• Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or related degree.
• Minimum of 4 years of experience in design assurance, quality, or related medical device or 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

Preferred Qualifications:

• 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.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.