Job ID R-512945 Date posted April 1, 2025

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.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

Job Description Summary

Associate Staff Sustaining Engineer

Job Description

Summary:
The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices in all stages of the product life cycle. This includes supporting design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance. The candidate will be responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, authoring technical documents, and presenting findings to management. In addition, the individual will be responsible for communicating requirements to suppliers and managing external resources to meet project milestones on time and within budget. The ideal candidate should have experience in medical device industry or related field. Knowledge of FDA regulations, IEC standards, ISO 10993, and quality system requirements such as MDSAP would be beneficial. Experience with design control process, risk analysis, and conducting human factors studies is required.

Responsibilities:
• Supports all phases of new product development and sustaining engineering activities including design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post-market surveillance.
• Responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, and presenting findings to management.
• Develops/update technical documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements.
• Manages external resources to ensure timely completion of projects. Communicates requirements to suppliers and ensures they are met.
• Works closely with cross functional teams to execute project plans.
• Performs activities in compliance with SOPs and other quality systems requirements.
• Participates in audits and inspections as needed.
• Applies fundamental knowledge of engineering fundamentals.
• Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
• Reports to Manager, Sustaining Engineering.

Qualifications:
• Bachelor’s degree in Engineering or Science discipline plus minimum of 8 years relevant experience OR Master’s degree in Engineering or Science discipline plus 6 years relevant experience.
• Medical device industry experience preferred.
• Ability to understand complex business processes and develop efficient solutions.
• Strong communication skills (written and verbal).
• Ability to travel domestically and internationally approximately 5% of time.
• Proficient computer skills (Microsoft Office Suite).
• Demonstrated ability to handle multiple competing priorities simultaneously while meeting deadlines.
• Ability to interpret data, draw reasonable conclusions, and make sound decisions based upon available information.
• Familiarity with Design Control Process and Risk Analysis.
• Working knowledge of FDA regulations (21 CFR Part 820), IEC Standards (60601 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

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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.

As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.


Zakiyyah Walker
Staff Engineer

Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.


Michael Carrano
Senior Program Manager

BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.


Justyna Zielinska
Project Manager

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