Sr Design Quality Engineer - Sustaining Engineering (606282)

Recruiter: Spencer Gregory Hale

Senior Design Quality Engineer Sustaining Engineering

About the role:

The Design Quality Engineer supports major products with high visibility providing the right candidate with excellent growth potential. Work with highperformance crossfunctional Sustaining Engineering (SE) team to ensure safety quality and compliance of launched products while continuously improving their commercial value through endoflife. Products transferred to SE include internally developed products Sourced Finished Medical Devices and acquired products. SE Design Assurance engineer works in close partnership with Research and 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 coordinate the execution 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).
• Mentor cross functional team through product development process; specifically with respect to design control and risk management deliverables
• Potential for supervisory responsibility

What were looking for in you:

Minimum qualifications:

• Bachelors degree in an Engineering discipline or related field of study
• 5 years of experience in design quality/design assurance new product development or related medical device experience
• Selfmotivated with a passion for solving problems and a bias for action
• Handson approach to product development
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies.
• ISO 13485 ISO 14971 EU MDR and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Preferred qualifications:

• MBA or advanced degree in science
• Previous supervisory experience
• Experience with technology acquisition & integration
• International project support/coordination

Requisition ID:606282

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.

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.