Location: Maple Grove, MN
Company: Boston Scientific
commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. Your responsibilities include: Sustaining Engineering: Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
Reviews and approves supplier corrective action plans and verification of effectiveness documentation. Proactively backsses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. Plans and leads audits of suppliers to backss
compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
New Product Development: Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers. Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Quality System Champion: Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development.
Includes generation, review, and implementation of these documents.
Identifies and advises management on potential improvements to quality systems and processes in the company. Champions 100% compliance to company policies and SOP’s. What we’re looking for in you: Minimal qualifications: BS degree in engineering or technical field with 5+ years relevant experience. Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry. Project management: the ability to influence cross-functional global teams spanning quality, operations, R&D, and sourcing. Experience in process validation, design controls, risk management, and CAPA.
Ability to work independently; organized and self-driven. Articulate communicator; adept at packaging and appropriately scaling information to the intended audience. Ability to rapidly learn and use new software applications (e. g. PLM, ERP). Domestic and international travel up to 25%. Preferred qualifications: 7+ years of medical device engineering experience. Leadership experience on a materials or service commodity team. Lead auditor of quality systems experience (ISO 13485 or similar). ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired. Requisition ID: 563810
Engineering jobs encompass a broad range of professions that involve the application of science and mathematics to solve problems and design, construct, and maintain structures, devices, and systems. These jobs are characterized by creativity, analytical skills, and the pursuit of technological innovation. Engineers can specialize in various fields, such as civil, mechanical, electrical, software, or biomedical engineering, each with its distinctive focus and techniques. A hallmark of engineering roles is their impact on shaping our built environment and the way we interact with technology, making them crucial for the advancement and sustainability of modern societies.
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Engineering jobs encompass roles that involve applying scientific and mathematical principles to design, develop, and maintain structures, machines, materials, systems, and processes. These positions are characterized by innovation, problem-solving responsibilities, and the need for technical expertise. Engineers can specialize in various fields such as civil, mechanical, electrical, chemical, and software, among others. They are essential in shaping the infrastructure of the modern world, formulating solutions to complex challenges, and driving technological advancement. Engineering roles often require a strong educational background combined with practical experience, and they stand out for their contribution to societal progress and potential for career growth.
Engineering jobs encompass a broad range of professions that involve the application of science and mathematics to solve problems and design, construct, and maintain structures, devices, and systems. These jobs are characterized by creativity, analytical skills, and the pursuit of technological innovation. Engineers can specialize in various fields, such as civil, mechanical, electrical, software, or biomedical engineering, each with its distinctive focus and techniques. A hallmark of engineering roles is their impact on shaping our built environment and the way we interact with technology, making them crucial for the advancement and sustainability of modern societies.
