Senior Process Engineer

Boston Scientific Gruppe; Coventry, Northern (RI, KY); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Sterilization Engineer to provide technical leadership for EtO sterilization and related quality activities across our global sterilization organization.

The role leads complex initiatives from manufacturing support to validation, compliance and continuous improvement, mentoring cross‑functional teams to ensure patient safety and product quality. This is an on‑site Rhode Island position.

Qualifications

• Bachelor's degree in engineering, science or a related technical discipline.
• Minimum of 5 years' experience in sterilization engineering, manufacturing engineering, process engineering or related field.
• Experience leading technical projects, investigations, or validations from planning through implementation.
• Experience with process development, validation, statistical analysis, and CAPA methodologies.
• Ability to communicate complex technical information to diverse stakeholders.

Responsibilities

• Provide advanced leadership for manufacturing-related sterilization operations and resolve complex issues.
• Lead investigations of significant nonconformances and develop robust technical solutions.
• Serve as SME in EtO sterilization, guiding cross-functional partners.
• Lead development, validation strategies, protocols and reports.
• Drive value improvement and continuous improvement initiatives for process capability and compliance.
• Define technical approaches, acceptance criteria, and risk for sterilization activities.
• Design and analyze experiments using appropriate statistical methods and translate results into actions.
• Author and approve technical reports and validation documentation.
• Mentor engineers and cross-functional teams to share sterilization expertise.
• Ensure compliance with FDA, ISO, EN and other regulatory requirements.

Skills

Sterilization engineering

Process validation

Statistical analysis

Root cause investigations

Education

Bachelor's degree in engineering or science

Job description

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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.

This Senior Sterilization Engineer role will provide technical leadership and subject matter expertise for internal sterilization processing while actively supporting ethylene oxide (EtO) sterilization processes and quality-related activities across our global sterilization organization. The role will independently lead complex technical initiatives spanning manufacturing support, process development, validation, continuous improvement and regulatory compliance. As a senior technical contributor, this individual will influence cross-functional decisions, mentor colleagues and drive solutions that advance operational performance while maintaining a strong commitment to patient safety and product quality.

This is an on-site position requiring employees to work from the local Boston Scientific facility. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Provide advanced technical leadership for manufacturing-related sterilization operations, independently identifying and resolving complex equipment, process and material-related issues.
• Analyze complaint and process trends, lead investigations of significant nonconformances, and develop robust technical solutions that improve sterilization process performance and reliability.
• Serve as a senior technical expert in EtO sterilization, providing guidance and recommendations to manufacturing, quality and cross-functional partners.
• Lead the development, review, execution and approval of sterilization process validation strategies, protocols and reports.
• Lead value improvement programs and continuous improvement initiatives, identifying opportunities to improve process capability, quality, efficiency and compliance.
• Lead sterilization process development and validation activities, including defining technical approaches, establishing acceptance criteria, assessing risk and authoring applicable protocols and reports.
• Design, execute and analyze complex experiments using appropriate statistical methods, partnering with Corporate Sterilization, Quality Assurance and other technical functions to translate results into actionable recommendations.
• Author and approve technical reports, validation protocols, validation reports and other documentation supporting EtO sterilization processes.
• Lead technical investigations of deviations and nonconformances, determine root causes, and develop and implement effective corrective and preventive actions.
• Interpret and apply site, corporate and regulatory requirements, including applicable FDA, ISO, EN and other standards, to ensure sustained process compliance.
• Develop, improve and maintain operating procedures, technical standards and associated training materials to support consistent execution and regulatory compliance.
• Own and maintain critical processing specifications and documentation, including load configurations, sterilization specifications and manufacturing documentation.
• Provide technical review and approval of process change controls, specifications and other documentation, assessing potential impacts to sterilization processes, product quality and regulatory compliance.
• Serve as a sterilization process subject matter expert during internal and external audits, providing technical rationale and supporting responses to audit observations as appropriate.
• Provide technical guidance and mentorship to engineers and cross-functional partners, sharing expertise and promoting consistent application of sterilization engineering principles.
• Influence cross-functional technical decisions and proactively identify opportunities, risks and solutions that support business and organizational objectives.
• 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.

Qualifications:

Required qualifications:

• Bachelor's degree in engineering, science or a related technical discipline.
• Minimum of 5 years' experience in sterilization engineering, manufacturing engineering, process engineering, quality engineering or a related technical field.
• Advanced technical and functional knowledge with demonstrated ability to apply engineering principles to complex sterilization, manufacturing or process-related challenges.
• Demonstrated experience independently leading technical projects, investigations, process improvements or validation activities from planning through implementation.
• Experience with process development, validation, statistical analysis, root cause investigation and corrective and preventive action methodologies.
• Ability to exercise independent technical judgment, evaluate multiple potential solutions and recommend appropriate courses of action for complex or ambiguous problems.
• Demonstrated ability to influence technical decisions and collaborate effectively across manufacturing, quality, engineering and other cross-functional teams.
• Ability to communicate complex technical information, risks and recommendations clearly to technical and nontechnical stakeholders.
• Demonstrated ability to manage multiple priorities and deliver high‑quality results with limited direction.
• Working knowledge of applicable quality systems, regulatory requirements and industry standards.

Preferred qualifications:

• Experience with EtO sterilization processes and sterilization validation.
• Experience supporting medical device manufacturing in an FDA‑regulated environment.
• Knowledge of applicable sterilization standards, including relevant ISO requirements.
• Experience applying statistical methods and design of experiments to process development, characterization or validation.
• Experience serving as a technical subject matter expert during internal, regulatory or external audits.
• Demonstrated experience mentoring engineers or providing technical guidance to cross‑functional teams.

Requisition ID:635470

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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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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