Design Quality Engineer III WATCHMAN

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:

We have an exciting opportunity for Design Quality Engineer III supporting WATCHMAN new product development projects within BSCs Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and new product development this position you will work with a Design Assurance and cross-functional team to support medical device product development from concept through commercialization and maintain the design control and risk analysis files.

Work mode:

At Boston Scientific we value collaboration and synergy. This hybrid role is based in Maple Grove MN at our Weaver Lake Campus and requires being on-site at least three days per week.

Relocation assistance:

Relocation assistance is available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities 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 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
• Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
• Applysystematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues with guidance/collaboration of the team
• 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.

What were looking for in you:
Required Qualifications:

• Minimum of aBachelors Degree in Mechanical Electrical or Biomedical Engineering or equivalent.
• Minimum of 3 years of experience in design assurance quality or related medical device or regulated industry experience
• Some experience in new product development: e.g. creating risk management deliverables (risk management plan/report hazard analysis task analysis dfmea etc.) design verification
• ISO 13485 ISO 14971 CFRs and Quality System Regulations understanding & demonstrated use
• Excellent organizational and planning skills; drives for results
• Strong communication skills (verbal & written) and presentation skills
• Ability to travel up to 10%

Preferred Qualifications:

• Experience in developing test methods
• Experience supporting clinical trials
• Self-motivated with a passion for solving problems and a bias for action.
• Focus on detailed work with emphasis on accuracy and completeness
• Ability to collaborate and work on a global team with peers in R&D Process Development Manufacturing and other groups.
• Experience with Class III Medical Devices

Requisition ID:619399

Minimum Salary:$76000

Maximum Salary: $144400

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre 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!

At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve.

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.

Please be advised that certain US based positions including without limitation field sales and service positions that call on hospitals and/or health care centers require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company you will be expected to meet the ongoing requirements for your roles including any new requirements should the Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest 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.