Boston Scientific Design Quality Engineer III 

United States, Massachusetts, Marlborough 

829361631

Your responsibilities include:

• Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
• Work with cross functional team members on Value Improvement Projects (VIPs) which are intended to continually improve the quality, delivery, and cost of BSC products.
• Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (eg. EN 14971).
• Support Usability Engineering and planning documentation (eg. EN 62366/ISO 62366)
• Interface with the core team and support the sustaining effort for both product and packaging designs.
• Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
• Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues.
• Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.
• Support internal and external regulatory audits as required.

What we’re looking for in you:
Required Qualifications:

• BS in Engineering (Biomedical, Electrical, Software or equivalent).
• 3-6 years of related experience.
• Travel approximately <10%
• In depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design & development and product risk management.
• Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
• Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
• High energy problem solver capable of driving items to closure.
• Strong communication (oral and written) and presentation skills.
• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.