- 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, SW Validation, Process Validation and Labeling).
- Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management
- 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).
- Provide quality guidance to assure country specific compliance.
- Champion compliance to company policies, work instructions and SOPs.
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
- 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.
- 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.
- BS in Mechanical, Electrical, Biomedical Engineering, or related degree.
- 5+ years of Medical Device engineering experience with BS, 3+ years with MS.
- Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
- Travel approximately 10-15%
- Strong communication (oral and written) and presentation skills.
- Ability to collaborate and work on a global team.
- Previous Experience in Problem Solving and CAPA methodologies.
- Focus on detailed work with emphasis on accuracy and completeness.
- Excellent organizational and planning skills; drives for results.
- High energy problem solver capable of driving items to closure.
- Minitab Statistical Analysis software (or equivalent).
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Sr. Design Quality Assurance Engineer - Marlborough, United States - Boston Scientific
Description
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.
Sr. Design Quality Assurance Engineer
Work mode: Hybrid
Onsite Location: Marlborough, MA
About the Role:
At Boston Scientific, the Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This individual will work with high-performance cross-functional development team to ensure safety, quality and compliance of launched products while continuously improving their commercial value. Initially, this position supports the transition of the current commercial portfolio to meet European Union Medical Device Regulation (EUMDR) requirements. This position is part of the design site for the Endoscopy division and can support activities including but not limited to New Product Development, Sustaining and Life Cycle Management and Quality Systems initiatives as they relate to design and development.
Provides quality engineering support to operations, product development and sustaining projects for current products on the market. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices 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.
This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of two days per week.
Your Responsibilities Include:
What We're Looking For:
Required Qualifications:
Preferred Qualifications:
Requisition ID: 580987
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.
