Senior Design Assurance Engineer - WATCHMAN

Additional Location(s): N/A

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

At Boston Scientific, we'll give you the opportunity to harness all that's 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, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role:

We have an exciting opportunity for a Senior Design Assurance (DA) Engineer supporting WATCHMAN new product development projects within BSC's 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 experience. In 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:

• In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams.

• Support the execution and documentation of Design Validation & Verification and Usability activities.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.

• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).

• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).

• Lead and support cross-functional root-cause analysis investigation and resolution activities

• Support regulatory submissions to notified bodies.

• 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 we're looking for:

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study

• Minimum of 5 years of experience in design assurance, quality, or related medical device or regulated industry experience
• Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation

• 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)

• Demonstrated use of Quality tools/methodologies
• Ability to travel up to 10%

Preferred Qualifications:

• Experience in developing test methods
• Experience supporting clinical trials

• Problem solver, capable of facilitating the problem-solving process

• Adaptable and effective collaborator in a team environment and in self-directed work
• 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:619400

Minimum Salary:$82600

Maximum Salary: $156900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will 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) 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!

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 Company's 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.