Job Description Summary
Job Description
Key Responsibilities
Develop and execute change management projects associated with design, labeling, packaging changes.
Lead creation and execution of verification protocols, summarize results, enable formal design reviews, and own the verification portion of the Design History File.
Define, plan and lead activities for test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
Demonstrate proficiency in spotting Design Variance through relevant statistical measures.
Follow Design Control & ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
Interpret and analyze design verification data with respect to product performance and operational stability in the manufacturing plants.
Application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose and implement robust solutions.
Synthesize, develop, update, and optimize designs based on understanding design space. Understand design options and tradeoffs; managing critical parameters; leverage strong engineering fundamentals and tools. Incorporate manufacturing principles early in the development process.
Ensure deliverables are reliable across the design space,isadequately pressure-tested to satisfy user, regulatory and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
Implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical,statistical,and analytical tools to drive informed design decisions and reduce design iteration cycle times.
Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, usability,reliability,and safety.
Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
Coach and mentor junior engineers and technicians to execute project deliverables.
Ensure compliance with BD quality policies, procedures, and practices.
Craft, edit, and interpret technical drawings and write protocols, reports, work instructions, presentations, etc.
Demonstrate accountability for the successful and timely achievement of goals.
Drive innovation and process efficiency.
Skills and Requirement
Bachelor’s Degree in Mechanical or Biomedical Engineering with minimum 8 years of experience in medical device or other regulated industry OR Master’s Degree in Mechanical or Biomedical Engineering and 5+ years of experience OR PhD in Mechanical or Biomedical Engineering and 3+ years of experience.
Expertise with design verification & validation strategy development and execution is required.
Expertise with test method development, validation strategy, and execution is required.
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 inleading 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 standards
Experience in solid modeling (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
Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modeling desirable.
DFSS training or certifications are a plus.
Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
Primary Work Location
IND Bangalore – Technology Campus
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
br{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Workstar Manpower bike captain pilot ₹ 22500 – 25500 /Month Job Type : full time...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Job Reference * JR00102335 Job Summary * Executive – Credit Operations Job Purpose “This position...
Apply For This JobFull Job Description To applay please send your updated resume to hrm@sevensenterprises.com Company Name:Sevens Consultancy Position:Team Leader – Automobile Sales...
Apply For This JobJob details Job Type Full-time Full Job Description Company Information: What we look for Our exceptional and motivated employees are...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> KRA- Head Electrical Ø Prepare detailed forward works plans for the electrical department in consultation...
Apply For This JobJob Description: RADIOLOGIST JOB IN WAYANAD KERALA Designation: CONSULTANT RADIOLOGIST Qualification: MD or DMRD or DNB Radiology 0-4 years experienced...
Apply For This Job