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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 Senior 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.
They are 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.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based at the Arbor Lakes Campus in Maple Grove, MN and requires being on-site at least three days per week.
Relocation assistance:Relocation assistance may be 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: - 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 BSC's 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 we're looking for in you:Required Qualifications:
- Bachelor's degree in engineering or science discipline, or equivalent.
- Minimum of 5 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: 631120 Minimum Salary: $ 85000 Maximum Salary: $ 161500 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.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn.
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 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.
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