Boston Scientific Design Assurance Engineer II 

United States, Minnesota 

395690957

We have an exciting opportunity for Design Assurance Engineer supporting WATCHMAN projects within the BSC’s Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. In a hybrid work mode, the Design Assurance Engineer II provides quality engineering support to digital application development/maintenance as well as product development/sustaining projects for current products on the market. The Design Assurance Engineer II will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. This Design Assurance Engineer II will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities.
Your responsibilities include:

• Independent reviews of quality system deliverables, within JIRA and Windchill systems, for Digital Health (DH) and Software as a Medical Device (SaMD) products, developed in-house or with external vendors.
• Collaborate with cross-functional teams (e.g., marketing, regulatory, legal, and software development) and external partners to create and review project or validation documentation (e.g., Software Intake Assessment, Software Validation Plan, etc.), ensuring compliance with Digital Health Quality System processes.
• Working knowledge of IEC62304, IEC82304, and ISO14971 standards.
• Collaborate globally with quality system stewards to enhance processes for digital health software development and compliance.
• Working knowledge of Design Controls and Risk Management. Collaborate with a cross-functional team to identify and implement effective controls through an ongoing basis.
• Provide quality and compliance input for product activities such as design changes, surveillance, design concessions, product CE marking and associated investigations: NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Support internal and external regulatory submission, information requests and audits, as required.

What we're looking for in you:
Required Qualifications

• Minimum of a Bachelors Degree
• Minimum of 2 years of risk management or related experience
• Medical device experience
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).

Preferred Qualifications:

• Self-motivated with a passion for solving problems and a bias for action
• Focus on detailed work with emphasis on accuracy and completeness
• Excellent organizational and planning skills; drives for results
• Strong communication (oral and written) and presentation skills
• High energy problem solver capable of driving items to closure
• Ability to collaborate and work on a global team

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.