Associate Staff Sustaining Engineer

4 days ago

IND Bengaluru Technology Campus, India BD Full time ₹ 15,00,000 - ₹ 25,00,000 per year
Job Description SummaryAssociate Staff Sustaining EngineerJob 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 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).

Required Skills

Optional Skills

.

Primary Work LocationIND Bengaluru - Technology CampusAdditional LocationsWork Shift

  • Associate Staff Engineer

    1 week ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryAssocaite Staff Engineer for Product Engineering . Med Tech Back Ground . Design Cntrols expertise . Mechnical EngineeringJob DescriptionPosition SummaryThe Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, leadand support the end-to-end Design and engineering deliverables and...

  • Associate Staff Engineer

    1 week ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryASE for Product EngineeringJob DescriptionPosition SummaryThe Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, leadand support the end-to-end Design and engineering deliverables and solutions for high-volume medical deviceproducts right from Design and Development to...

  • Manager, Quality Engineering

    16 hours ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryManages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process,...

  • Software Engineer

    4 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Job Description SummaryJob DescriptionAbout BD: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. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and...

  • Design Engineer II

    2 weeks ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryThe Design Engineer will assist the design and engineering solutions for high-volume medical device products. (S)he, under the mentorship of a lead or senior engineer, will deliver relevant solutions to existing products through Project scoping, Project planning, design iterations, risk-retirement using first principles engineering,...

  • Software Engineer

    4 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Description SummaryMMS Infusion is looking for a Senior SW Engineer who has passion for learning, developing high quality, customer focused and impactful SW products.Job DescriptionBD 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...

  • Software Engineer

    4 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Description SummaryMMS Infusion is looking for a Senior SW Engineer who has passion for learning, developing high quality, customer focused and impactful SW products.Job DescriptionAbout BD: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...

  • Senior Quality Engineer

    4 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Job Description SummaryPerforms a variety of quality assurance activities to ensure successful completion of projects or aspects of large programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and evaluation of medical devices. Supports development and successful...

  • Lead Quality Engineer

    4 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description SummaryAs directed by the Quality Manager, the Lead Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an...

  • [Urgent] Associate Staff Engineer

    3 days ago

    Bengaluru, India BD Full time

    Job Description Job Description Summary Assocaite Staff Engineer for Product Engineering . Med Tech Back Ground . Design Cntrols expertise . Mechnical Engineering Job Description Position Summary The Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, lead and support the end-to-end Design and...