Boston Scientific Design Quality Engineer II 

United States, Minnesota 

979301060

Your responsibilities include:

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Develops and executes plans for design control and risk management of complex projects

• Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Working knowledge of Design Controls. Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).

• Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations

• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure.

What we’re looking for in you
Required Qualifications

• Bachelor’s degree in engineering or science discipline, or equivalent.

• 3+ years experience in design assurance, quality, or related medical device or regulated industry experience

• Knowledge of basic Quality System Requirements and Good Documentation Practices
• High energy problem solver capable of driving items to closure.

• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)

Preferred Qualifications

• Experience with Class III Medical Devices

• Experience with Capital Equipment

• Experience with design control, risk management, and medical device standards compliance
• Experience with corrective and preventive action

Maximum Salary: $ 132000

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive 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.