Senior Systems Engineer

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.

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.

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 (3) days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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

Requisition ID: 611003

Minimum Salary: $ 82600

Maximum Salary: $ 156900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.