Additional Location(s): N/A
About the role: Boston Scientific is currently recruiting for a Design Quality Engineer II at our Arbor Lakes campus in Maple Grove, MN. This is an exciting opportunity to participate as a design assurance team member in the development of capital equipment products for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.
The Design Quality Engineer II will support the application of design controls and risk management to projects with a focus on new product development. This individual will work within a high performing cross-functional team to ensure safety, quality, and compliance of products.
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 (3) 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 will include: - Develop, update, and maintain Design History File and Design Input / Output documentation (e.g., Product Specification, Component Specifications, and Prints)
- Develop, update, and maintain product Risk Management documentation (e.g., Hazard Analysis, Fault Tree, FMEAs)
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements
- Work within a cross-functional team to identify and implement effective controls and support new product and commercial design changes, specifically with regard to quality and risk management
- Apply sound, systematic problem-solving methodologies to resolve quality issues
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs
- Apply basic problem-solving techniques to identify, communicate, and resolve quality issues
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
What we're looking for in you: Required qualifications:
- Bachelor of Science degree in engineering or related field
- 2+ years of experience in an engineering role within medical device or similar regulated industry
- Knowledge of Quality System Requirements, Good Documentation Practices, and relevant standards and regulations (e.g., ISO 13485, ISO 14971)
- Comfortable working independently and as part of a cross-functional team
- Collaborative mindset and willingness to learn in a team-oriented environment
- Strong written and verbal communication skills
Preferred qualifications:
- Bachelor's degree in Electrical, Computer, or Biomedical Engineering
- Familiarity with quality tools and methodologies include DFMEA, Hazard Analysis, and Root Cause Analysis
- Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics
- Experience with technical writing, such as specifications, test protocols, and technical reports
Requisition ID: 635253Minimum Salary: $ 71500 Maximum Salary: $ 135800 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will 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.
