Boston Scientific Senior Design Assurance Product Performance Engineer 

United States, Minnesota, Maple Grove 

324932646

Your responsibilities include:

• Functional lead who applies sound, systematic problem-solving methodologies in identifying, analyzing, prioritizing, communicating, and resolving quality issues.
• Facilitate cross-functional team to identify/implement effective controls and support product performance/development.
• Demonstrates sound working knowledge and application of risk management file.
• Assess, maintain, and update product trending (e.g. Risk Thresholds) and evaluate associated product risk management impact (e.g. Hazard Analysis, Fault Tree, FMEAs).
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Mentor for technical guidance for identifying and resolving quality issues.
• Acts as an effective leader/team member in supporting quality disciplines, decisions, and practices.
• Support submissions to notified bodies.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Mentor cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.

Minimum qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
• 5+ years’ experience in Design Quality or related medical device experience; or Master’s degree and 3 years’ experience
• Hands-on approach to product development
• Demonstrated use of Quality tools/methodologies
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

Preferred qualifications:

• 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)
  

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.