Job title: Senior Design Engineer
Company: CR Bard
Job description: Job Description Job Description Summary Job Description Job Title: R&D Sr. Engineer Reports To: BD-TCI Sustaining Engineering R&D Manager BD Medical – Vascular Access Devices – is searching for a Senior R&D Engineer to be part of a team focused on s
Job Description Job Description Summary Job Description Job Title: R&D Sr. Engineer Reports To: BD-TCI Sustaining Engineering R&D Manager BD Medical – Vascular Access Devices – is searching for a Senior R&D Engineer to be part of a team focused on sustaining engineering activities to support the Peripheral Intravenous Catheters. The scope of this position includes, working knowledge of Quality Management Systems (ISO 13485), design history files and risk management (ISO 14971). We are recruiting a highly driven senior technical team member with passion for problem solving and a proven track record of successfully designing medical products. The successful candidate will be responsible for the following activities: Product Design Lead or support design and development activities for new and existing products. Support current products in terms of quality, manufacturing, supply continuity and cost improvement. Participate in executing technical and/or cross-functional project work. Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance. Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. Translate customer needs into engineering requirements into specific product, packaging and process specifications Engineer robust and manufacturable products through strong understanding and application of engineering fundamentals Analyze design solutions using engineering first principles and advanced engineering methods such as FEA Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis Develop design verification traceability matrices and associated requirements analysis Develop realistic and actionable design plans Develop project schedules and drive projects to completion on time Write detailed technical reports based on design verification analysis/testing for design changes and product design activities Ensure compliance with BD quality policies, procedures, and practices as well as with all local, state, federal and BD safety regulations, policies and procedures Lead and ensure implementation and rigor of design control best practices with compliance to BD quality policies and procedures through appropriate communication, training, and education of sound quality assurance principals. Leadership/Project Management Demonstrate strong accountability for successful completion of designated tasks Provide design control leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices. Responsible for developing and implementing critical component changes for high volume, disposable medical devices. Influence others: Demonstrate strong persuasion and timing skills. Remain open to be persuaded when appropriate. Inclusive work environment: Promote and leverage diversity to achieve best outcomes. Leadership courage: Demonstrate and promote leadership courage by doing what is right. Engage those who disagree to persuade or be persuaded. Instill confidence in associates and customers. Dealing with ambiguity: Demonstrate agility and action orientation when facing change and uncertainty. Effectively manage change and instill confidence. Quality systems processes: Ensure implementation of quality systems processes including design controls and change control. Project planning: Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities and associated resource requirements. Project management: Contribute to scope definition and effort estimates for project plans. Be accountable for timely delivery of project deliverables for which is responsible as specified in the project plans. Stakeholder Management: Identify project stake holders, establish and monitor stakeholder engagement Technology transfer: Ensure efficient and effective transition from research to development to manufacturing in locations throughout the world Process effectiveness: Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in project activities. Innovation: Develop and apply innovative approaches to ensure best outcomes in all aspects of the role. Support an environment in which innovation can flourish through empowerment, encouragement, and support. Qualifications Bachelor’s degree (Mechanical or Biomedical) required. in related technical field. Advanced degree preferred. Minimum of 4-6 years of engineering experience is required. Medical device design and development experience related to high-volume manufacturing is strongly preferred. Experience to include: Demonstrated ability to deliver robust products by following a disciplined design process Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred Strong design control experience Experience with developing innovative solutions to complex problems Experience writing invention disclosures, patent applications, patents, and publications Strong understanding of DOE and statistical methods. Strong understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions Experience with clinical studies, human physiology, and simulated product use studies. Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting. Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ’s. Knowledge of disciplined product development processes, regulatory and quality requirements such as 21CFR820.30 Analyze design solutions using engineering first principles and advanced engineering methods Write detailed technical reports based on design verification analysis/testing for design changes and product design activities Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
Location: Bangalore, Karnataka
Job date: Thu, 27 Jan 2022 23:44:51 GMT
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