Process Engineer II

Boston Scientific; Coventry (CO); On-site; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific in Colorado is seeking an EtO sterilization engineer to provide technical support for manufacturing-related sterilization operations, drive process improvements and ensure regulatory compliance and patient safety.

The role covers development, validation and continuous improvement of EtO sterilization processes, review deviations, and prepare reports while collaborating with Quality Assurance and corporate teams to maintain site standards and regulatory readiness.

Qualifications

• Expanded conceptual, technical and functional knowledge within the job function.
• Working knowledge of business and industry practices and company processes needed to accomplish assigned work.
• Ability to exercise judgment to solve problems in straightforward situations and determine appropriate actions and solutions.
• Ability to work under general direction from more senior-level colleagues or management while remaining accountable for individual contributions and objectives.
• Ability to work within established guidelines and policies while contributing to the quality of individual and team deliverables.
• Ability to organize, present and explain data and factual information to internal audiences.

Responsibilities

• Provide ongoing technical support for manufacturing-related sterilization operations, including process improvements and troubleshooting of sterilization equipment, processes and material-related issues.
• Review complaint trends, investigate and resolve nonconformances, and provide sterilization engineering support to manufacturing operations.
• Serve as a technical expert in the EtO sterilization process.
• Support the development, review and approval of sterilization process validation activities.
• Support value improvement programs and lead continuous improvement activities.
• Support sterilization process development and validation activities, including the development of applicable protocols and reports.
• Create, execute and analyze experiments using statistical methods, collaborating with Corporate Sterilization and Quality Assurance teams as appropriate.
• Prepare sterilization technical reports, validation protocols and validation reports for EtO sterilization.
• Review internal deviations and investigate and implement corrective and preventive actions to support compliance with procedures and regulatory requirements.
• Ensure compliance with site and corporate requirements, as well as 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 a sterilization process subject matter expert during audits.
• 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.

Skills

Sterilization engineering

EtO sterilization

Process validation

Quality Assurance

Statistical methods

Regulatory compliance

Job description

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.

This role will focus primarily on internal sterilization processing while actively participating in ethylene oxide (EtO) sterilization processes and quality-related activities that support our global sterilization organization. The role provides technical expertise across manufacturing support, process development, validation, continuous improvement and regulatory compliance, with a commitment to patient safety and product quality.

Work model, sponsorship, relocation:

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 ongoing technical support for manufacturing-related sterilization operations, including process improvements and troubleshooting of sterilization equipment, processes and material-related issues.
• Review complaint trends, investigate and resolve nonconformances, and provide sterilization engineering support to manufacturing operations.
• Serve as a technical expert in the EtO sterilization process.
• Support the development, review and approval of sterilization process validation activities.
• Support value improvement programs and lead continuous improvement activities.
• Support sterilization process development and validation activities, including the development of applicable protocols and reports.
• Create, execute and analyze experiments using statistical methods, collaborating with Corporate Sterilization and Quality Assurance teams as appropriate.
• Prepare sterilization technical reports, validation protocols and validation reports for EtO sterilization.
• Review internal deviations and investigate and implement corrective and preventive actions to support compliance with procedures and regulatory requirements.
• Ensure compliance with site and corporate requirements, as well as 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 a sterilization process subject matter expert during audits.
• 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:

• Expanded conceptual, technical and functional knowledge within the job function, with the ability to apply relevant concepts to sterilization engineering activities.
• Working knowledge of business and industry practices and company processes needed to accomplish assigned work.
• Ability to exercise judgment to solve problems in straightforward situations and determine appropriate actions and solutions.
• Ability to work under general direction from more senior-level colleagues or management while remaining accountable for individual contributions and objectives.
• Ability to work within established guidelines and policies while contributing to the quality of individual and team deliverables.
• Ability to organize, present and explain data and factual information to internal audiences.

Requisition ID: 634322

Minimum Salary: $ 75100

Maximum Salary: $ 142600

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 atwww.bostonscientific.comand follow us onLinkedIn.

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.