Boston Scientific Senior Systems Engineer 

United States, Minnesota 

44248101

About the role:

This role will 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 will 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 from early-career engineers
• Submit specification, protocol, and report for approvals and documentation control via a Change Request
• Develop comprehensive software validations and/or equipment qualification protocols per the specification
• Execute software validation and/or qualification protocols & record results
• Document, 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 Requests 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 guidance, mentoring, and training to early-career engineers; ensure consistency of work among early-career engineers; provide peer reviews on specifications, protocols, and reports
• Influence and define functional, departmental, and divisional policies & procedures through involvement with cross-functional engineering initiatives
• Provide leadership role on championing functional best practices

Required qualifications:

• Bachelor’s degree in Engineering discipline
• 5+ years direct, professional experience relevant to this role
• Experience in Medical Device manufacturing, specifically writing compliance documentation
• In-depth knowledge of MS Office tools
• Must have excellent organization skills, clear verbal and written communication skills
• Experience working in a SDLC-system development lifecycle
• Hands-on skills using/navigating equipment user interfaces
• Exemplary attention to detail and ability to support multiple priorities at once
• Ability to support many customers from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

Preferred Qualifications:

• Experience working in FDA-regulated industry
• Experience working with a regulatory body in an audit
• Performed in a quality role ensuring industry compliance
• Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)
• Team-oriented with effective interpersonal skills

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.