Design Quality Engineer II (605784)
Design Quality Engineer II (605784)
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Job Description
Additional Location(s):USMNMaple Grove
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:
Boston Scientific Peripheral Interventions has an opportunity for a Design Quality Engineer II to join our Vascular team to grow and develop our portfolio of products. The DQ Engineer II will work crossfunctionally to ensure safety quality and compliance of the device while delivering the highest quality product to the customer. This role will serve as a Quality team member on NPD Sustaining and/or Integration projects and will utilize quality engineering methodologies and practices which meet BSC customer and regulatory requirements.
Your responsibilities will include:
- Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
- Develops understanding of Design Controls Risk Management and Usability for Medical Devices
- Supports departmental functional and divisional design quality goals and priorities
- Executes methodologies to effectively meet individual and team objectives
- Execute methodologies such as Statistical Analysis Risk Management and Root Cause Analysis in support of project activities
- Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics Product Life Cycle Process (PLCP)
- Applies critical thinking and engineering analysis to solve problems
Required qualifications:
- BS in Mechanical / Biomedical Engineering or related discipline or equivalent
- 2years experience in design assurance or related field or a combination of education and experience to perform at this level
- Knowledge of key regulatory requirements including ISO 14791 (Risk Management) 21 CFR 820 (US QS Regulation) ISO 13485 (Quality Management Systems) EU MDR and IEC 623661 (Usability)
- Ability to travel up to 10%
Preferred qualifications:
- Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management
- Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards
- Strong technical knowledge problemsolving abilities collaborative mindset and effective communication skills
- Experience with medical device development for single use devices
- Ability to work independently and as part of a team
Requisition ID:605784
Minimum Salary:$69500
Maximum Salary: $132000
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.
Employment Type
Full Time
