Senior Design Quality Engineer 601634
Senior Design Quality Engineer 601634
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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:
Join our Interventional Cardiology Team where we create innovative technologies to diagnose and treat cardiovascular disease. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.
We are thrilled to be developing a new platform technology to treat calcified artery disease. We are looking for a dynamic Senior Design Quality Engineer to provide focused quality engineering leadership for single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC) which is a rapidly growing division of Boston Scientific.
This role offers a unique chance to work on the integration of innovative technologies gain endtoend exposure to the product development cycle and excel in a dynamic fastpaced environment. If you are passionate about advancing Medtech device product development and making a significant impact lets connect and explore this exciting opportunity together!
Design Quality drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans risk management plans and reports hazard analysis design FMEA analysis of use error (task analysis) sampling systems / procedures and statistical techniques verification protocols/testing/reports validation protocols/testing/reports. This Senior level role involves influencing and executing functional plans and collaborating with crossfunctional teams and will be responsible for ensuring quality and compliance through integration product development and commercialization.
Your responsibilities will include
- & strategy of deliverables such as Design and Development Planning Risk Management Design Verification and Validation Usability Validation plans Design Review Field Assessment Design Change and NCEP/CAPA/PIR
- Effectively communicates within project team across functions and elevates issues above the project team as appropriate
- Develops solutions to technical problems. Investigate failure modes perform root cause analyses and develop solutions to address technical challenges. Ensure compliance with relevant regulatory requirements and standards
- Execute crossfunctional plans provide feedback to overall project strategy knows when to solicit feedback and facilitate project decisions to ensure successful product development and integration
- Builds quality into all aspects of work by maintaining compliance to all quality requirements defending work as well as support internal & external regulatory audits
- Author and review design documentation including technical reports design history files design verification protocols/reports and regulatory submissions. Present project updates and technical insights to stakeholders.
What were looking for in you
Required qualifications:
- Bachelors degree in mechanical electrical biomedical chemical engineering or related discipline
- 4 years of related experience in design assurance new product development or related medical device or regulated industry experience
- Experience with Risk Management Standard ISO 14971
- Experience with class III medical devices
- Experience with reliability testing
- Demonstrated use of Quality tools/methodologies
- Strong technical knowledge problemsolving abilities collaborative mindset and effective communication skills
Preferred qualifications:
- An independent critical thinker; willingness to challenge status quo
- Understanding of electrical safety standards IEC 60601
- Previous experience with product integrations
- Strong knowledge of QSR and ISO standards
Requisition ID:601634
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
