Senior Design Quality Engineer - Peripheral Interventions (605515)
Senior Design Quality Engineer - Peripheral Interventions (605515)
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1 Vacancy
Job Description
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 highperforming 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 Senior Design Quality Engineer product development activities Medical Electrical Equipment within Boston Scientifics Interventional Oncology and Embolization and Vascular portfolios. In a hybrid or onsite work mode the Senior Design Quality Engineer will work crossfunctionally to ensure safety quality and compliance of a System. This role will serve as quality lead on System design development verification validation and maintenance throughout the full Product Life Cycle Process.
Your responsibilities include:
- Representing the voice of quality as a Core Team member on product development team to ensure that design implementation meets the intent of product design while meeting quality standards and strategic business objectives.
- Develop and maintain understanding of the product/therapy space including clinical use applications to effectively integrate this knowledge with functional quality management system requirements.
- Application of Design Control and Risk Management processes throughout product development lifecycle independently or as a member of a team. Provide quality and compliance input to colleagues for project decisions and deliverables.
- Creation execution and documentation of System Design Validation & Verification activities such as protocols test cases reports investigation and resolution of issues identified during test.
- Collaborate with crossfunctional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis Task Analysis Design Failure Mode and Effects Analysis and Software Design Failure Mode and Effects and Analysis
- Apply sound systematic problemsolving methodologies in identifying prioritizing communicating and resolving quality issues.
- Provides quality input as a subject matter expert and or independent reviewer. Support internal and external regulatory audits as required.
- Advise management on potential improvements or enhancements to quality systems processes and products in the company.
What were looking for in you:
Required Qualifications:
- Bachelors degree in engineering physics math or other science discipline or equivalent.
- Minimum of 4 years experience in design quality system test systems R&D or product development engineering in Medtech /regulated industry experience; or equivalent combination of education and experience
- Understanding and demonstrated use of industry standards (e.g. IEC 60601 IEC 62304). within product design and development process
- Strong ability to navigate ambiguous situations in a collaborative innovative and peoplecentric team environment.
- Knowledge of key regulatory requirements including of ISO 13485 Quality Management Systems ISO 14971 Risk Management 21 CFR 820 and EU MDR.
- Travel approximately <10%
Preferred Qualifications:
- Experience in Complex Systems Development or Integration Engineering
- Variable and Attribute Test method generation and validation experience
- Prior exposure to risk management tools & methodologies such as hazard analysis FMEA 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:605515
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 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 nonexempt (hourly) nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm 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 problemsolver 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 COVID19 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 COVID19 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 COVID19 vaccination.
Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safetysensitive positions. This role is deemed safetysensitive 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.
Required Experience:
Senior IC
Employment Type
Full Time
