Boston Scientific Design Assurance Engineer III 

United States, Massachusetts, Waltham 

238476222

Your responsibilities include:

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
• Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Maintains product risk management documentation (i.e. Hazard Analysis & FMEAs).
• Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Able to navigate gray space by applying risk-based criteria to prioritize project work.
• Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

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

• Minimum of a bachelor’s degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
• Minimum 5 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience.
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
• Experience navigating design, manufacturing and/or supplier variations

Preferred Qualifications:

• Strong understanding of NCEP/CAPA processes
• Previous experience working to create/maintain risk documentation such as FMEAs and HAs
• Experience working with Stature or FMEA MED-8 software would be excellent, but is not required
• Self-motivated with a passion for solving problems and a bias for action.
• Ability to manage multiple priorities and work with ambiguity.
• Strong communication skills (verbal & written).
• Proficiency in collaborating with interdisciplinary teams.
• Familiar with EP environment
  

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.