Design Quality Engineer III - Interventional Cardiology

Onsite Location(s):
Maple Grove, MN, US, 55311

Additional Location(s): N/A

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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.

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.

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

Requisition

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 — 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…