דרושים Senior Eh & Specialist ב-Boston Scientific ב-United States, Carlsbad

About the role:

Boston Scientific is seeking a highly experienced and proactiveto lead environmental, health, and safety initiatives across manufacturing and R&D operations. This critical role ensures compliance with regulatory requirements, mitigates workplace risks, and champions a culture of safety, sustainability, and continuous improvement.

Your responsibilities will include:

● Develop, implement, and maintain EH&S policies and procedures in compliance with federal, state, and local regulations.

● Conduct risk assessments, inspections, and performance analyses to identify hazards and implement corrective actions.

● Lead incident investigations and root cause analyses; ensure timely resolution and documentation.

● Deliver training on hazardous materials handling, emergency response, industrial hygiene, laser safety, and general workplace safety.

● Evaluate work-related injuries and incidents in alignment with applicable laws and internal protocols.

● Manage hazardous waste and chemical handling operations to maintain compliance and safety.

● Collaborate with engineering, facilities, and operations teams to embed EH&S into process improvements.

● Mitigate ergonomic risks across manufacturing and office environments through proactive assessments, workstation design, training, and best practices.

● Maintain and enhance the laser safety program through site-specific protocols, risk assessments, and comprehensive training.

● Serve as a liaison with fire, police, and HAZMAT agencies to support emergency preparedness and response planning.

● Support onboarding and ongoing safety education programs.

● Coordinate Emergency Response Team activities and ensure overall site readiness.

● Chair or contribute to EH&S-related committees, task forces, or cross-functional teams.

● Represent EH&S in cross-functional projects such as new chemical introductions, equipment implementations, and facility changes.

● Maintain and report site EH&S metrics and statistics to ensure regulatory and corporate compliance.

● Act as the facility’s Hazardous Materials/Waste Coordinator, including oversight of all regulated and non-regulated waste streams and vendor management.

● Provide regulatory guidance for equipment specifications, installations, and facility modifications.

● Conduct internal and external EH&S compliance audits, self-assessments, and inspections.

● Partner with Supervisors, Trainers, and Technicians to identify and control environmental health and safety risks across operations.

Required qualifications:

● Bachelor’s degree in Environmental and Occupational Health, Occupational Safety, Safety Engineering, or Safety Management. Equivalent experience may be considered in lieu of a degree.

● Minimum of 5 years' experience in progressive EH&S roles.

● Demonstrated experience in medical device, biotech, or advanced manufacturing environments.

● Strong knowledge of relevant regulatory frameworks and compliance standards.

● Proven ability to influence, lead, and coach across multiple departments.

● Effective communicator with strong problem-solving and leadership skills.

● Experience leading ergonomic and injury prevention initiatives, including risk assessments and root cause analysis.

● Ability to develop and deliver EH&S training programs to diverse audiences.

Preferred qualifications:

● 7 or more years' experience managing EH&S programs with site-wide impact.

● Familiarity with EH&S metrics reporting, incident tracking systems, and internal audit programs.

Maximum Salary: $ 164500

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.

About the role:

You will oversee a diverse portfolio of initiatives ranging from small-scale tasks to large-scale process improvements, design changes, line extensions, and design transfers. This role requires close collaboration with cross-functional teams across business units and global manufacturing sites.

Your responsibilities will include:

● Develop and implement an overall sustaining strategy from product launch through end of life to ensure product continuity.

● Manage project structure and governance, including scope, roles and responsibilities, workstreams, risks, communication, and alignment.

● Develop a comprehensive set of project milestones and a project plan to define budget and resource needs.

● Guide the team through decision-making by analyzing options and presenting logical recommendations.

● Communicate project status and performance through standard reports, dashboards, and update meetings.

● Lead cross-functional teams to evaluate, design, build, and implement solutions aligned with project objectives.

● Identify, communicate, and manage technical risks and knowledge gaps.

● Serve as the liaison between the project team and leadership/governing bodies, ensuring alignment and visibility.

● Create and manage submission cadence in partnership with Regulatory Affairs to support R&D, process improvement, and business continuity projects.

Required qualifications:

● Bachelor’s degree (Master’s degree preferred).

● Minimum of 5 years' experience as a Project Manager or in a similar role leading cross-functional teams in the medical device industry.

● Strong business acumen and strategic leadership capabilities.

● Excellent written and oral communication skills with the ability to present to senior leadership.

Preferred qualifications:

● PMP certification.

● Experience working across all levels of an organization and engaging with external stakeholders.

● Strong leadership, interpersonal, and relationship-building skills within project teams.

● Technical problem-solving expertise.

● Familiarity with U.S. and EU regulatory bodies and medical device classifications.

● Proficiency in Microsoft Project.

● Experience managing projects involving catheter and console (system) components.

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.

About the role:

You will oversee a diverse portfolio of initiatives ranging from small-scale tasks to large-scale process improvements, design changes, line extensions, and design transfers. This role requires close collaboration with cross-functional teams across business units and global manufacturing sites.

Your responsibilities will include:

● Develop and implement an overall sustaining strategy from product launch through end of life to ensure product continuity.

● Manage project structure and governance, including scope, roles and responsibilities, workstreams, risks, communication, and alignment.

● Develop a comprehensive set of project milestones and a project plan to define budget and resource needs.

● Guide the team through decision-making by analyzing options and presenting logical recommendations.

● Communicate project status and performance through standard reports, dashboards, and update meetings.

● Lead cross-functional teams to evaluate, design, build, and implement solutions aligned with project objectives.

● Identify, communicate, and manage technical risks and knowledge gaps.

● Serve as the liaison between the project team and leadership/governing bodies, ensuring alignment and visibility.

● Create and manage submission cadence in partnership with Regulatory Affairs to support R&D, process improvement, and business continuity projects.

Required qualifications:

● Bachelor’s degree (Master’s degree preferred).

● Minimum of 5 years' experience as a Project Manager or in a similar role leading cross-functional teams in the medical device industry.

● Strong business acumen and strategic leadership capabilities.

● Excellent written and oral communication skills with the ability to present to senior leadership.

Preferred qualifications:

● PMP certification.

● Experience working across all levels of an organization and engaging with external stakeholders.

● Strong leadership, interpersonal, and relationship-building skills within project teams.

● Technical problem-solving expertise.

● Familiarity with U.S. and EU regulatory bodies and medical device classifications.

● Proficiency in Microsoft Project.

● Experience managing projects involving catheter and console (system) components.

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.

About the role:

Boston Scientific is seeking aSenior Quality Engineerto provide quality engineering leadership and support for manufacturing process development and implementation. This position partners closely with Manufacturing to ensure the production of disposable medical catheters complies with all applicable regulatory and quality system requirements.

This role plays a critical function in driving validation activities, risk management, and product lifecycle support while ensuring a robust and compliant manufacturing process.

Your responsibilities will include:

● Oversee ethylene oxide (EO) sterilization validation processes and ensure routine sterilization meets regulatory standards.

● Support environmental monitoring and cleanroom verifications per schedule; assist with excursion investigations.

● Review and approve manufacturing validation test plans, protocols, and reports.

● Lead completion of risk management deliverables, including process Failure Mode and Effects Analyses (pFMEA) and Control Plans.

● Support and lead test method validation activities to ensure reliable and accurate testing.

● Develop, review, and approve inspection plans, Device History Records (DHRs), and product drawings for new products.

● Create and implement quality plans to ensure product and process compliance.

● Drive defect prevention and detection efforts within manufacturing.

● Provide statistical support and problem-solving expertise for process validations and engineering protocols.

● Support Management Review, internal/external audits, deviations, CAPAs, NCRs, supplier management, and RGAs.

● Provide quality support for New Product Development activities.

● Lead resolution of quality issues related to CAPAs and NCRs.

● Ensure compliance with quality system procedures and applicable regulations.

Technical expertise:

● Provide technical expertise on component schematics and inspection requirements.

● Identify opportunities for improvement in both product quality and the quality system.

● Ensure accurate development and verification of Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs).

● Oversee calibration and preventive maintenance programs to ensure equipment reliability (as needed).

● Manage supplier quality activities including audits, performance assessments, and quality agreements (as needed).

Required qualifications:

● Bachelor’s degree in a scientific or engineering discipline, or an equivalent combination of education and experience.

● Minimum of 5 years' experience in a regulated industry such as medical devices or pharmaceuticals.

● Experience in catheter design and manufacturing while working in Quality.

● Strong understanding of GMPs and regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820).

● Proficient in interpreting engineering drawings.

● Experience with risk management records and performing risk analysis.

● Hands-on experience with test method validation and Gage R&R studies.

● Knowledge of statistical techniques including normality analysis and tolerance analysis.

● Proficient in Minitab or equivalent statistical software.

Preferred qualifications:

● Expertise in EO sterilization validation (ISO 11135).

● Knowledge of biocompatibility standards (ISO 10993 series).

● Strong analytical, planning, and organizational skills.

● Excellent written and verbal communication skills.

● Self-motivated and capable of working independently in a fast-paced environment.

● Proficiency with MS Office tools: Word, Excel, PowerPoint, Project, and Visio.

Maximum Salary: $ 164500

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.