Associate Staff Sustaining Engineer
2 weeks ago
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 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).
Required Skills
Optional Skills
.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift
-
Sustainability Workplace Manager
2 weeks ago
Bengaluru, Karnataka, India JLL Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJLL empowers you to shape a brighter way. Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where...
-
Staff AI Engineer
6 days ago
Bengaluru, Karnataka, India SeedlingLabs Private Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per yearAs a Staff AI Engineer, you will be a technical leader responsible for designing and implementing the core architectural components of the *AI Workbench platform* and ensuring all delivered applications achieve sustained production quality and scale. You will work within*"small, skilled AI-native teams"*using a *"Human + AI Co-creation"*approach to deliver...
-
Sustainability Workplace Manager
2 weeks ago
Bengaluru, Karnataka, India JLL Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJLL supports the Whole You, personally and professionally.Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology to our clients. We are committed to hiring the best, most talented people in our industry; and we support them through professional growth, flexibility, and...
-
Bengaluru, Karnataka, India Millennium Technology Services Full time ₹ 8,00,000 - ₹ 24,00,000 per yearRole OverviewTheService Reliability and Sustainability Engineeris responsible for ensuring the reliability, scalability, and sustainability of enterprise systems and services. This role bridges the gap between operations and engineering, focusing on automation, observability, performance optimization, and environmental sustainability in IT infrastructure.The...
-
GTC Sustainability
1 week ago
Bengaluru, Karnataka, India AtkinsRéalis Full time ₹ 15,00,000 - ₹ 30,00,000 per yearJob DescriptionOverviewLead the Sustainability and Environment (S&E) practice for AtkinsRéalis in India and support the Consulting, Strategy & Advisory (CS&A) capability practice.Lead the development and implementation of the S&E team strategy to ensure its continued growth, technical excellence and positioning in the marketplace as a trusted...
-
Sustainability Consultant
2 weeks ago
Bengaluru, Karnataka, India Omada Rail Systems Full timeDesign & EngineeringPermanent ContractMid-Senior LevelBengaluruAbout UsEgis is an international player active in architecture, consulting, construction engineering and mobility services. We create and operate intelligent infrastructures and buildings that respond to the climate emergency and contribute to more balanced, sustainable and resilient territorial...
-
Sustainability Consultant
2 weeks ago
Bengaluru, Karnataka, India Egis Full timeCompany DescriptionEgis is an international player active in architecture, consulting, construction engineering and mobility services. We create and operate intelligent infrastructures and buildings that respond to the climate emergency and contribute to more balanced, sustainable and resilient territorial development. Operating in 100 countries, Egis puts...
-
Sustainability Consultant
2 weeks ago
Bengaluru, Karnataka, India Egis Group Full timeCompany Description Egis is an international player active in architecture, consulting, construction engineering and mobility services. We create and operate intelligent infrastructures and buildings that respond to the climate emergency and contribute to more balanced, sustainable and resilient territorial development. Operating in 100 countries, Egis puts...
-
Sustainability Consultant
2 weeks ago
Bengaluru, Karnataka, India Egis Group Full timeCompany DescriptionEgis is an international player active in architecture, consulting, construction engineering and mobility services. We create and operate intelligent infrastructures and buildings that respond to the climate emergency and contribute to more balanced, sustainable and resilient territorial development. Operating in 100 countries, Egis puts...
-
Sustainability Consultant
2 weeks ago
Bengaluru, Karnataka, India Egis Group Full timeCompany Description Egis is an international player active in architecture, consulting, construction engineering and mobility services. We create and operate intelligent infrastructures and buildings that respond to the climate emergency and contribute to more balanced, sustainable and resilient territorial development. Operating in 100 countries, Egis puts...
