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Lead Supplier Engineering Specialist
3 months ago
Additional Location(s): Canada-ON-Ottawa
Core Values: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we empower you to leverage your full potential by collaborating with a diverse and high-performing workforce, addressing critical challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to supporting your professional growth and career advancement. Here, you will find encouragement to pursue your aspirations.
Role Overview
The Senior Supplier Engineer acts as a technical authority for the TheraSphere division, overseeing and directing all facets of projects and initiatives aimed at enhancing processes and materials initiated by Boston Scientific or Contract Manufacturing (CM) partners. In this capacity, the Senior Supplier Engineer will independently manage and provide strategic direction on projects for integrating new service providers, collaborating with cross-functional teams to fulfill deliverables aligned with business objectives for the TheraSphere product line. The Supplier Engineering Team is tasked with delivering technical leadership and resolving non-conformances and process enhancements, ensuring business continuity and the seamless integration of product and process modifications at CM sites under Boston Scientific's standards. The Senior Supplier Engineer will play a pivotal role in driving performance improvements of Sourced Finished Medical Device (SFMD) suppliers to consistently align with Boston Scientific's expectations. This position necessitates a strong commitment to patient safety and collaboration with suppliers and cross-functional teams to guarantee that product quality meets customer standards.
Key Responsibilities Include:
Spearhead initiatives and projects with suppliers to pinpoint improvement opportunities and offer guidance and support for process advancements. Assess and initiate projects concerning mass escalation and reactor capacity to ensure manufacturing capabilities are adequately established to meet anticipated product demand. Cultivate open and transparent communication with suppliers to ensure a mutual understanding of expectations and objectives. Demonstrated experience in leading and managing large-scale process improvement initiatives utilizing six sigma and lean manufacturing methodologies. Collaborate and facilitate communication with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory, to align supplier performance with corporate objectives. Direct the execution of SFMD Engineering and Quality deliverables while collaborating with cross-functional new product development teams to contribute to the next generation of the device. Engage with suppliers to assist in the investigation of supplied material issues or supply constraints. Investigate and resolve supplier-related challenges, such as non-conformances, quality discrepancies, and delivery delays, in a prompt and effective manner. Execute and support NCEP/CAPA investigations to identify and address root causes for process deviations and component modifications. Assist in product complaint investigations where supplied materials may be a potential root cause, employing basic statistical tools as necessary. Ensure compliance with the Quality Policy and all documented quality processes and procedures to uphold Boston Scientific's commitment to patient safety and product quality.Required Qualifications:
Bachelor's degree in engineering, preferably in Biomedical Engineering. Experience in a regulated environment adhering to ISO13485 and FDA standards. Over 7 years of relevant experience as a Supplier/Sustaining Engineer. Proficiency in statistical tools, such as Minitab. Strong report writing skills. Solid understanding of statistical methods, problem-solving techniques, and six sigma methodologies.Preferred Qualifications:
Effective communication skills at all levels, with strong technical writing and reporting capabilities. Highly organized and detail-oriented; adept at prioritizing and managing multiple projects. Strong interpersonal skills with the ability to cultivate internal and external relationships. Results-oriented with robust critical thinking and analytical abilities. Experience in working with nuclear medicine and radioactive materials. Proven experience in leading projects with suppliers and/or contract manufacturers.Requisition ID: 583213
Boston Scientific maintains a prohibited substance-free workplace. Pursuant to applicable laws, Boston Scientific prohibits the unlawful manufacture, sale, distribution, dispensation, possession, or use of controlled substances or marijuana in the workplace, with violations resulting in disciplinary action up to and including termination.
Please note that certain positions may require acceptable proof of COVID-19 vaccination status. Candidates will be informed during the interview and selection process if proof of vaccination is a condition of employment. Boston Scientific continues to assess its policies regarding the COVID-19 vaccine and will comply with all applicable laws and healthcare credentialing requirements.
