DUTIES: Lead, coordinate, and support the execution and documentation of design validation, verification, and usability activities. Plan voice of customer/animal labs to evaluate possible design changes. Apply problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Perform troubleshooting on new products/process problems as related to design, material, or process. Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization as well as sustaining engineering activities for released products. Develop, update, and maintain design history file and design input / output documentation (User Needs, Product Specification and Component Specifications). Update and maintain product risk management tools (i.e. Hazard Analysis, Task Analysis, FMEAs). Support regulatory submissions to notified bodies (EUMDR transition) and assist in the preparation of Design History Files (DHF), Risk Management Files (RMF), and Verification & Validation (V&V) documentation for regulatory and internal/external audits. Maintain compliance to the Quality Policy and all other documented quality processes and procedures. Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk. Conduct Signal Evaluation Forms (SEF) and risk escalations as part of complaint management. Design CAPAs owner, non-conformance investigations and solution implementation. Prepare standard reports/documentation to communicate results to technical community. Assist on Complaint Management Center (CMC) and Complaint Investigation Site (CIS) on the analysis, investigation, and reporting information regarding medical devices. Create market surveillance strategies, support complaint review board, support any product investigation based on complaints. Apply engineering principles to develop Test Methods. Create and Develop Test Method Validations (attribute or variable) using tools like Capability analysis (Minitab) or executing Gage R&R studies. Define and support Material Qualification process for components provided by suppliers. Support manufacturing process validations (IQ/OQ/PQ, review of AACs and process improvement projects (VIPs) focused on cost reduction and variability reduction. Lead and support Manufacturing transfer with sister plans and SFMD (Source Finished Medical Device). Mentor new engineers in Design Control/Design Validation/Design Verification/Design Changes/Process Changes/Validations/CAPA process. May require travel/Telecommute. REQUIREMENTS: Employer requires a Bachelors degree or foreign equivalent in Industrial Engineering or related technical field plus 60 months of progressive, post-baccalaureate experience in the job offered, Quality Engineer, Process Engineer, or related occupation. Experience must include: 1) Large Scale C++ Medical software application development, including multithread programming on Linux system, 2) Signal and Image Processing, 3) Rapid prototyping, 4) MATLAB/Python, 5) Source Code management, CI/CD practices, 6) Software Architecture, 7) Medical Software Development process (IEC62304 compliance, requirements management), 8) Microsoft .NET (WPF, WCF), and 9) DICOM Standards. WORKSITE: 100 Boston Scientific Way, Marlborough, MA, 01752 SALARY: $135,325 to $150,717 per year CONTACT: Susan Cardinal, Boston Scientific Corporation, (email removed). Must include reference H9. Boston Scientific offers medical & dental coverage, well-being support, & 401K plan (EOE).
