
Design Assurance Engineer
Are you a highly skilled and detail-oriented engineer looking for a rewarding career opportunity? Boston Scientific is seeking a Design Assurance Engineer to join our dynamic and innovative team. As a Design Assurance Engineer, you will play a crucial role in ensuring the safety, reliability, and quality of our medical devices. We are looking for candidates who possess a strong technical background, a passion for problem-solving, and a dedication to excellence. If you are driven by a desire to make a positive impact on the healthcare industry, we encourage you to apply for this exciting position.
- Develop and implement design verification and validation plans to ensure the safety and effectiveness of medical devices.
- Conduct risk assessments and identify potential hazards or issues related to product design.
- Collaborate with cross-functional teams to ensure design changes and updates are properly reviewed and approved.
- Oversee the design control process, including documentation and change management.
- Utilize statistical methods and tools to analyze data and identify trends in product performance.
- Create and maintain detailed design verification and validation protocols and reports.
- Investigate and resolve product quality issues, including conducting root cause analyses and implementing corrective and preventive actions.
- Stay up-to-date on industry standards, regulations, and best practices related to medical device design.
- Communicate with stakeholders, including management, engineering teams, and regulatory bodies, regarding design assurance activities and results.
- Train and mentor junior team members on design assurance processes and procedures.
- Support external audits and inspections related to design assurance.
- Continuously identify opportunities for process improvement and implement changes to enhance design assurance practices.
- Maintain accurate and organized documentation of all design assurance activities.
- Adhere to all company policies, procedures, and regulatory requirements.
Minimum Of 3-5 Years Of Experience In Medical Device Design And Development.
Bachelor's Or Master's Degree In Biomedical Engineering, Mechanical Engineering, Or A Related Field.
Strong Knowledge Of Fda Regulations And Industry Standards For Medical Device Design And Manufacturing.
Experience With Risk Management Processes, Including Fmea And Dfmea.
Ability To Work Effectively In A Cross-Functional Team Environment And Communicate Complex Technical Information To Non-Technical Stakeholders.
Quality Management
statistical analysis
Root Cause Analysis
Process validation
Risk assessment
DOCUMENT CONTROL
Regulatory compliance
Design Control
Failure mode analysis
Test method development
Supplier management
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Design Assurance Engineer in Marlborough, MA, USA is between $77,000-$117,000 per year. This can vary depending on factors such as experience, education, and the specific company and industry.
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Boston Scientific Corp. engages in the development, manufacture and marketing of medical devices that are used in interventional medical specialties. Its products and technologies are used to diagnose or treat medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health and chronic pain conditions.

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