Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Responsibilities
Job Description Summary
This position supports product leadership and risk management of new product development and sustaining activities.Job Description
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
- Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
- Leads development of risk assessments and test methods
- Leads component qualifications, design validation / verification and process validation
- Leads product investigations
- Ability to make and present risked based decisions
- Assess product changes against product design
- Supports translation of design inputs into manufacturing control plans
- Develop and implement procedures to comply with corporate and industry standards.
- Coordinates and/or directs all aspects of product development activity related to a product line
- Leads development of risk assessments and test methods
- Quality engineering representation on Product Development Teams
- Prepare and present project updates and technical discussions
- Participate in project planning, budgeting, scheduling, and tracking
- Support internal and external supplier audits
- Provide support to the regulatory department in writing technical submissions
- Complies with company procedures and policies, government regulations
- Other duties and projects, as assigned
Required Qualifications:
- Knows how products are used and impact the user(s) so that risk can be managed effectively
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
- Ability to lead creation of risk management files
- Ability to develop solutions with business impact
- Advanced statistical and risk assessment techniques
- Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
- Ability to make and present risk-based decisions
- Strong interpersonal skills
- Ability to analyze and optimize manufacturing and quality systems
- Product, design & prototyping
- Ability to create and provide training
- Problem solving ability
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Oral and written presentation skills
- Ability to Lead cross functional teams
- Understanding of regulatory requirements including ISO 13485, ISO 14971
Preferred Qualifications:
- Quality Engineering Certification (ASQ) or equivalent
Education and/or Experience:
- BS in Engineering
- Minimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Primary Work Location
IND Bangalore - Technology CampusAdditional Locations
Work Shift
Success Profile
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Collaborative
- Conceptual
- Creative
- Imaginative
- Problem-solver
- Team player
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.