Senior System Design Quality Engineer

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 aSenior System Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support an Imaging Guidance System a significant product line with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls software development lifecycle (SDLC) risk management product development regulatory and standards compliance compliance corrective and preventive actions improvements for manufacturability and cost-reduction efforts.The Senior System Design Quality Engineer is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

At Boston Scientific we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office three days per week.

Relocation assistance is available for this position.

Boston Scientific will not consider offering sponsorship or take over sponsorship of an employment visa for this position.

Your responsibilities include:

• Responsible for design control and risk management of next-generation medical devices
• International standards compliance including ISO 9001 ISO 13485 ISO 14971 IEC 60601-1 and IEC 62304.
• Uses clinical knowledge to influence how devices they are working on are tested and designed
• Applies sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues
• Independently or as a member of a team develops directs and executes plans for design control and risk management of complex projects
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis Fault Tree FMEAs)
• Promotes and influences compliance to BSCs quality business and health & safety systems and market/legal regulations
• Provides quality input (SME and/or independent reviewer) as required at defined project/product/process milestones (e.g. design reviews project design plans design/process changes to existing product lines).
• Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group

• Participates in the implementation of product software including risk management (per ISO 14971) hazard analysis software FMEAs security risk analysis software design V&V
• Acts as an effective leader or team member in supporting quality disciplines decisions and practices.

What were looking for in you:
Required Qualifications:

• Bachelors degree in engineering or science discipline or equivalent.
• Minimum of 10 years experience in design assurance quality or related medical device or regulated industry experience
• ISO 9001 ISO 13485 ISO 14971 IEC 60601-1 and IEC 62304 CFRs and Quality System Regulations understanding & demonstrated use
• Strong communication skills (verbal & written) and presentation skills
• Problem solver capable of facilitating the problem-solving process & driving issues to closure
• Excellent organizational and planning skills; drives for results
• Adaptable and effective collaborator in a team environment and in self-directed work
• Ability to work in a highly matrixed and geographically diverse business environment as the product expands Globally.
• Demonstrated use of Quality tools/methodologies

Preferred Qualifications:

• Focus on detailed work with emphasis on accuracy and completeness
• Ability to collaborate and work on a highly matrixed and global team
• Experience with Class III Medical Devices

Requisition ID:612209

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 --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) 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 identify 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.