Additional Location(s): N/A
About the role: Boston Scientific is currently recruiting for a Sustaining Design Quality Engineer III in our Arbor Lakes, MN location. This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.
The Design Quality Engineer III will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance 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: - Ownership of design change projects including scoping, assessment, and implementation.
- Develop, update, and maintain Design History File and Design Input / Output documentation
- Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
- Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
- Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Demonstrates 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's degree in an engineering discipline
- Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
- Knowledge of basic Quality System Requirements and Good Documentation Practices
Preferred qualifications:
- Bachelor's degree in mechanical, electrical, or biomedical engineering
- Experience with design control, risk management, and medical device standards compliance
- Experience with corrective and preventive action
- Adaptable and effective collaborator in a team environment and in self-directed work
- Strong communication skills (verbal & written)
Requisition ID: 634497 Minimum Salary: $ 78300 Maximum Salary: $ 148800 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.
