Design Quality Assurance Engineer II - Sustaining Engineering Peripheral Interventions 603878
Design Quality Assurance Engineer II - Sustaining Engineering Peripheral Interventions 603878
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1 Vacancy
Job Description
Recruiter: Spencer Gregory Hale
Design Quality Assurance (DQA) Engineer II Sustaining Engineering Peripheral Interventions
About the role:
The Design Quality Assurance Engineer II supports a major product category with high visibility which will provide the right candidate with excellent growth potential. Work with highperformance crossfunctional Sustaining Engineering team to ensure safety quality and compliance of launched products while continuously improving their commercial value through endoflife. Products transferred to Sustaining Engineering (SE) include internally developed products Sourced Finished Medical Devices and acquired products.
This position will be located in Maple Grove MN and will provide key project support for design changes market expansion product performance monitoring risk assessments and cost reduction activities. The SE Design Quality Assurance engineer works in close partnership with Operations Project Management Regulatory and Research & Development and focuses on protecting the design intent of a product to meet safety efficacy regulatory and business requirements.
Your responsibilities include:
- Actively promote and participate in a crossfunctional teamwork environment.
- Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
- Maintains product risk management documentation (i.e. Hazard Analysis Fault Tree FMEAs).
- Supports product Post Market activities such assessment of risk based on post market signals field assessments and post market surveillance plans and reports.
- Leads/supports the determination and implementation of Design Controls based on Risk Management Customer Needs and Manufacturing Input.
- Leads the development of and coordinates the and documentation of Design Validation and Verification activities.
- Applies sound systematic problemsolving methodologies in identifying prioritizing communicating and resolving quality issues.
- Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
- Perform regulatory standard assessments and support regulatory submissions to notified bodies.
- Maintain Design History File and Design Input / Output documentation (Product Specification Component Specifications and Prints).
- Collaborate with crossfunctional new product development team to facilitate design ownership transfer to SE team; specifically with respect to design control risk management and usability deliverables.
What were looking for in you:
Minimum qualifications:
- Bachelors degree in an Engineering discipline or related field of study
- 24 years of experience in design assurance sustaining engineering or related medical device experience
- Selfmotivated with a passion for solving problems and a bias for action
- Handson approach to project work and collaboration
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies.
- ISO 13485 ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Management
Preferred qualifications:
- International crossfunctional collaboration
Requisition ID:603878
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.
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.
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
