Design Assurance Quality Engineer III
Boston Scientific · Marlboro, MA
- Level
- Senior
- Team
- Quality
- Travel
- 20%
- Degree
- Required
- Experience asked
- 3+ years
- Industry
- Medical devices
- Posted
- 8 days ago
The role in 30 seconds
A senior quality role at Boston Scientific (medical devices) in Marlboro, MA. Develop, establish, and maintain quality-engineering methodologies, system, and practice which meet BSC, customer, and regulatory requirements.
- They ask for
- 3+ years · degree required
- Tools it names
- Six Sigma, DMAIC, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)
- Day to day
- about 20% travel · relocation help
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- 1
Pick 2–3 people on the Quality team at Boston Scientific
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- 2
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- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
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- 4
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About the role
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.
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).
Minimum Salary: $ 82100
Maximum Salary: $ 156000
For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .
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Additional Location(s): N/A
Diversity - 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.
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.
Y our
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