Additional Locations: Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges. Together, we re one global team committed to making a difference in people s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life s work. Job Title: Systems Engineer II About This Role: To ensure the quality of Boston Scientific Corporation s software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Your Responsibilities Include: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control via a Change Notice Develop comprehensive software validations and/or equipment qualification protocols per the specification. Execute software validation and/or qualification protocols & record results. Document and communicate and follow-up on software/equipment issues. Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements. Create documents, links and Change Notices utilizing a Product Data Management system. Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures. Develop and review comprehensive validation procedures in compliance with FDA. Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations. Provide peer reviews on specifications, protocols and reports. Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives. Provide leadership role on championing functional best practices. What We're Looking For: Minimum Qualifications: Bachelr s Degree in Engineering Discipline (please define is any certain discipline is preferred) 3-5 years direct experience Experience in Medical Device manufacturing specifically writing cmpliance documentation In depth knwledge of MS Office tools Must have excellent rganization, clear verbal and written skills Experience wrking in a SDLC-system development lifecycle Hand n skills using navigating equipment user interfaces High level attentin to detail and ability to support multiple priorities at once Must be team-riented with people skills and positive can-do attitude in dealing with a large number of customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc) Preferred Qualifications: Experience wrking in FDA-regulated industry Experience wrking with a regulatory body in an audit Perfrmed in a quality role ensuring industry compliance Practical knwledge of 21 CFR Part 11 (electronic records/electronic signature) About us As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you re looking to truly make a difference to people both around the world and around the corner, there s no better place to make it happen. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran Requisition ID: 448122
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