Design Assurance Quality Engineer III

Additional Location(s): N/ADiversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

The Design Assurance Engineer directly supports medical devices through operations, product development and sustaining functions. Develop, establish, and maintain quality-engineering methodologies, system, and practice which meet BSC, customer, and regulatory requirements. Serves 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. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance:

Relocation assistance is not available for this position at this time.

Visa Sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint 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).Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).Champion

compliance to company policies, work instructions and SOPs.Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.

Support internal and external regulatory audits as required.

Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management

Required Qualifications Minimum of a Bachelors degree in Biomedical Engineering, Mechanical Engineering or related degree.

Minimum of 3 years of medical device engineering experience.

Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.Travel approximately 10-20%.

Preferred Qualifications:

Strong communication (oral and written) and presentation skills.

Ability to collaborate and work on Global team Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies (Six Sigma / CQE certification preferred).

Requisition  Salary: $ 82100

Maximum Salary: $ 156000

The anticipated compensation…