Senior Process Engineer
Coventry, RI, US, 02816
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:
Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.
In this role, you will serve as a subject matter expert on Boston Scientific's internal ethylene oxide (EtO) sterilization processes, related equipment, procedures, documentation and applicable external standards. Your primary focus will be supporting internal sterilization processing while actively participating in EtO sterilization process and quality activities across our global sterilization organization.
Work model, sponsorship, relocation:
This is an on-site role based in Coventry. Regular on-site presence is required to support manufacturing and sterilization operations. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is available for this position.
Your responsibilities will include:
- Serve as a technical subject matter expert for EtO sterilization processes, equipment, procedures, documentation and applicable standards.
- Provide ongoing sterilization engineering support for manufacturing operations, including process improvements and troubleshooting sterilization equipment, process and material issues.
- Review complaint trends, investigate and resolve nonconformances, and support corrective and preventive actions.
- Support the development, review and approval of sterilization process validation activities.
- Support value improvement programs and lead continuous improvement activities related to sterilization processes and operations.
- Support sterilization process development and validation activities, including developing applicable protocols and reports.
- Create, execute and analyze experiments using appropriate statistical methods in collaboration with Corporate Sterilization and Quality Assurance teams.
- Prepare technical reports, validation protocols and validation reports for EtO sterilization processes.
- Review internal deviations and investigate and implement corrective and preventive actions to maintain compliance with procedures and regulatory requirements.
- Ensure compliance with site and corporate requirements and applicable FDA, ISO, EN and other regulatory requirements.
- Develop and maintain operating procedures and associated training materials to support compliance with industry and regulatory standards.
- Maintain processing specifications and required documentation, including load configurations, sterilization specifications and manufacturing documents, as needed.
- Review and approve process change control documentation and specifications.
- Serve as the sterilization process subject matter expert during audits.
- Support team members by setting an example and providing coaching, feedback and guidance.
- Lead small projects or project phases with manageable risks and resource requirements.
- Exchange complex technical information with cross-functional partners and participate in meetings and presentations to clearly communicate key messages.
Qualifications:
Required qualifications:
- In-depth conceptual, practical and technical knowledge of principles and theories related to the role, with a general understanding of related functions.
- Demonstrated experience applying technical and functional knowledge across a variety of situations to accomplish objectives.
- Ability to understand key business drivers and how closely related teams collaborate to accomplish objectives and improve efficiency.
- Demonstrated ability to solve problems of varying scope and complexity, applying established solutions while exercising judgment and proposing appropriate alternatives.
- Ability to work independently within company policies, guidelines and procedures while seeking guidance for complex or unprecedented situations.
- Ability to communicate complex information effectively and collaborate with cross-functional teams.
Preferred qualifications:
- Experience with EtO sterilization processes, sterilization equipment and manufacturing operations.
- Experience supporting sterilization process development and validation activities.
- Experience developing and executing validation protocols, technical reports and controlled documentation.
- Experience applying statistical methods to process development, validation or continuous improvement activities.
- Knowledge of applicable FDA, ISO, EN and other regulatory or industry requirements related to sterilization.
- Experience investigating deviations and nonconformances and supporting corrective and preventive actions.
- Experience supporting audits as a technical or process subject matter expert.
Quality system requirements:
In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
For individuals who supervise others:
- Ensure appropriate resources, including personnel and tools, are maintained to support Quality System compliance and adherence to the Boston Scientific Quality Policy.
- Establish and promote a work environment that supports the Quality Policy and Quality System.
Requisition ID: 633398
Minimum Salary: $ 89200
Maximum Salary: $ 169500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will 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.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.
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 identity, 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.
Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island
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