Boston Scientific Design Quality Engineer II 

United States, Minnesota 

155466758

Your responsibilities will include:

• Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices
• Supports departmental, functional, and divisional design quality goals and priorities
• Executes methodologies to effectively meet individual and team objectives
• Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities
• Ensure adherence to the quality systems and design assurance SOPs and Boston Scientific’s Product Life Cycle Process (PLCP)
• Applies critical thinking and engineering analysis to solve problems

Required qualifications:

• BS in Mechanical / Biomedical Engineering or related discipline or equivalent
• 2+ years’ experience in design assurance or related field, or a combination of education and experience to perform at this level
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability)
• Ability to travel up to 10%

Preferred qualifications:

• Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management
• Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards
• Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills
• Experience with medical device development for single use devices
• Ability to work independently and as part of a 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.