R&D Engineer II

4 weeks ago

Bengaluru India CR Bard Full time

Job Description

Job Description Summary

Primary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation assist/write technical documents, validation protocols and reports perform/coordinate hands-on testing of a device assist in failure investigations and support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

1. Design: serve as subject matter expert of components of a medical device, including design evaluation for proposed changes to materials, processes, suppliers, tolerances, clinical use scenarios and international standards.

2. Process Validation: assists in the development and review of process validation (IQ, OQ, and PQ) to qualify process and design changes, using statistical methods and software as appropriate.

3. Documentation: write protocols, technical documents, and reports. Prepare and edit raw material specifications and drawings. Assist in preparing verification and validation protocols and reports. Review and update documents such as Design Input Requirements, Design History File, and End Item Specification

4. Test Method Development: develop engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians prepare and assist in the validation of test methods.

5. Testing: coordinate/perform lab bench testing, conduct engineering and competitor evaluations, assist with failure investigations, and verification and validation activities.

6. Training: train technicians on new design and process development as well as new test methods.

Other Responsibilities may include, however are not limited to:

- Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
- Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- Experience: 3-5 years of industrial experience in R&D, quality, or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
- Demonstrated hands-on technical aptitude.
- Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization ability to assist in executing validation.
- Experience in creating and/or interpreting engineering drawings/specifications
- Excellent oral and written communication skills.
- Ability to work in cross functional teams.

Preferred Qualifications:

- Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
- Knowledge of cGMP and GLP is a plus.
- Training in Six Sigma or Design for Six Sigma is a plus.

Education and/or Experience:

- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- Experience: 3-5 years of industrial experience in R&D, quality, or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

Required Skills

Optional Skills

.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

  • R&D Engineer II

    2 weeks ago

    Hyderabad, India Medtronic Full time

    Job Description At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Careers that Change Lives Be a part of the Medtronic Engineering and Innovation...

  • Engineer-R&D

    3 weeks ago

    Roorkee, India Attero Full time

    Job Description Objective:- Assist the Technical Services manager in putting together Attero's capacity creation requirements, complete with definition of functional requirements, technology selection, technology transfer for the entire capacity creation & getting the new site(s) in readiness for commercial operations comprising - Assist the Technical...

  • R&D Engineer II

    5 days ago

    Bengaluru, Karnataka, India BD Full time US$ 60,000 - US$ 1,20,000 per year

    Job Description SummaryPrimary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device;...

  • R&D Engineer II

    6 days ago

    IND Bengaluru - Technology Campus, India BD Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job Description SummaryPrimary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device;...

  • R&D Manager

    1 day ago

    Bengaluru, India BD Full time

    Job Description Job Description Summary Seeking a high-level R&D Manager/Associate Staff Engineer who is a highly organized and results-driven professional with strong project management skills to lead complex, cross-functional initiatives. Primary focus of this position is to help execute, oversee and support strategic projects including Global UDI...

  • R&D Engineer

    1 week ago

    Bengaluru, Karnataka, India ABB Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This Position reports to:R&D Team LeadYour role and responsibilities:In this role, you will have the opportunity to contribute to ABBs success with technology, software, product, and system development. Each day, you will identify and implement innovative solutions to relevant problems. You will also showcase your expertise by providing ideas and by being...

  • ▷ [Urgent] Senior R&D Engineer

    1 day ago

    Bengaluru, India BD Nogales Norte Full time

    Job Description Job Description Summary Seeking a senior level engineer who is a highly organized and results-driven professional with strong project management skills to lead complex, cross-functional initiatives. Primary focus of this position is to oversee and support strategic projects including Global UDI implementation, Product Stewardship (covering...

  • R&D Escalations Engineer

    4 weeks ago

    Gurugram, Gurugram, India Tufin Full time

    Job Description Tufin is the leader in Network Security Policy Orchestration, allows enterprises to streamline the management of security policies across complex, heterogeneous environments. Serving over 2,500+ customers, Tufin's network security automation enables enterprises to implement changes in minutes with proactive risk analysis and continuous...

  • R&D Engineer

    1 week ago

    Bengaluru, Karnataka, India ABB Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    This Position reports to:R&D Department LeadYour role and responsibilities :In this role, you will have the opportunity to contribute to ABBs success with technology, software, product, and system development. Each day, you will identify and implement innovative solutions to relevant problems. You will also showcase your expertise by providing ideas and by...

  • R&D Internship

    2 weeks ago

    Bengaluru, India GiftdMinds Full time

    Role : UAV and UUV R&D Intern - Full Time Onsite (Bangalore)Internship Duration : 4-6 months + Opportunity to convert into full time job opportunity based on Internship Review MeetingLocation : Bangalore (GiftdMinds R&D and Learning Center, HSR Sec-1)Roles & Responsibilities :Skills :: As a Hands-on Engineer ----------------------------------Must...