BD — jobs and company profile

Bangalore, India

EducationFull time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial & Production, Chemical, Materials Engineering) or master's degree in a relevant engineering field is an added advantage.Experience7 - 12 years of experience in the engineering/technical field, with 3 years demonstrated project and team leadership, preferably in the medical device industry with a successful track record of project completion.Strong exposure to six sigma and lean methodologies would be an advantage. Candidates with prior experience in Medical Devices will be preferred.KnowledgeSix Sigma knowledge/Black /Greenbelt certification, DFSS, MSAPMP Certifications/Project Management knowledgeISO 20417, ISO 15223-1, ISO 13485, ISO 14971, ISO 62304Sustenance Engineering project delivery knowledgeStatistics and Verification methodsTool knowledge SAP, Master control, JDE added advantage Exposure to CAD/CAE tools (Solid Works, AUTOCAD, PRO-E, etc.) specializing in mold flow, structural designs, CFD and plastics domain is desired.Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.) will be an added advantage.Expertise with test method development, validation strategy, and execution is required.Expertise with design verification & validation strategy development and execution is required.Expertise in fixture design & development.Strong track record of technical problem solving and effective product development through expert application of engineering principles is required.Design controls expertise and experience with traditional and modern fabrication techniques is required.Proven experience in leading CAPAs, design-defect analyses, remediation is required.Proficiency in solid mechanics/mechanics of materials and proficiency statistical methods/tools is required.Experience with design standard methodologies, including advanced tolerance design, and design for reliability.Working with regulatory standardsExposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modelling desirable.SkillsAbility to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.Strong interpersonal and influence skills.Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.Ability to analyze, organize and present large amounts of data in a clear and concise manner.Disciplined, detailed, and well organized with managing documentation in a regulated environment.Ability to execute concurrently multiple projects and manage priorities.Ability to work independently with global exposure is desired.Strong written and verbal communication skills.Advanced Problem-solving skills.Strong Cross-functional Project Leadership skills.Strong technical and managerial judgment.Team orientation.Strong skills in project planning and management.Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.Strong motivational fit.Strong fit with BD values.Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)Experience in solid modelling (SolidWorks) or electromechanical systems is a plus.Experience in high-volume manufacturing processes is a plus.Experience developing and commercializing medical devices is a plus.DFSS training or certifications are a plus.

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