Hi ,

We have the below open position please have a look and let me know your
interest.


*Job Title: R&D Engineer Location: San Diego, CA*

*Duration: 4 Months*


*GENERAL FUNCTION:*

Reporting to the BD manager, this associate shall plan, lead, review and
front-end Design Verification, Sustaining Engineering and New Product
Development projects as a technical contributor cum project leader and
engages in all aspects of product development / sustenance / remediation.


*EDUCATION:*

Bachelor’s or higher education in Mechanical Engineering or related
engineering/technology streams (Manufacturing / Mechatronics / Polymer
Science / BioMedical)



*EXPERIENCE:*

At least 5-7 years of working experience in design and development of new
products, preferably in a regulated industry (Medical Devices / Aerospace).



*CORE SKILLS:*

·         MUST have excellent communication skills (verbal, written,
presentation & articulation), appropriate for varying levels of
stakeholders.

·         Strong project management background in R&D or manufacturing
environment

·         Strong experience in tolerance analysis of plastic components in
molding and assembly.

·         Excellent analytical and problem-solving skills, as well as a
good background in product development/manufacturing process specifically
in high volume molding & assembly operations.

·         Experience in leading and managing a small group of engineers and
technicians

·         Demonstrated ability to effectively, critical thinking and
clearly communicate concepts, ideas, and knowledge to other individuals and
teams.

·         Experience in fixture design & development and test method
development, implementation and validation.

·         Desirable experience with ISO requirements and GMP guidelines,
FDA regulations, medical device design control, and manufacturing scale up
processes.

·         Good on statistical concepts such as in measurement system
analysis and design verification.

·         Proficient in Microsoft Office products with an emphasis on MS
projects, Excel and Word.



*RESPONSIBILITIES*

1.       Leads the Design Verification, Sustaining Engineering & New
Product Development projects and applies the best engineering practices and
tools.

2.       Demonstrates excellent project management, contributes on projects
as the R&D member, carrying out assigned responsibilities in a timely,
diligent, safe and professional manner.

3.       Develops and maintains good rapport with business leaders, other
internal functions, technical consultants, outside vendors, and other
stakeholders to accomplish project objectives and be a strong team-player.

4.       Reviews the deliverables to ensure completeness, accuracy, and
appropriateness of the design output/test executed and ensure its
compliance with Good Documentation Practices.

5.       Provides training to the team on GDP/GLP, IQ/OQ process,
Calibration & Preventive maintenance activities and ensures the quality of
deliverables.

6.       Involves in the review/creation of DV Protocols and provides
valuable inputs regarding test equipment selection, capability/accuracy,
sample size optimization, acceptance criteria definition,  etc.

7.       Conducts Weekly Status Review Meeting with stakeholders, shares
the progress of various projects supported/led, keeps a track on the
self-utilization.

8.       Promptly follow-up with the parties concerned for
review/approval/signatures of project artifacts (including Memos, MSA, DV
Protocol & Reports, IQ/OQ Protocols & Reports, etc).

9.       Quality System accountability: Maintains all relevant Protocols,
Procedures, Reports and Records to ensure strict compliance of R&D
functional operation to meet the Quality System requirements.

10.   Supports the organization’s intellectual property strategy by
documenting data and independent, unique and patentable ideas that result
from experimentations.

11.   Performs any other tasks (like Sustaining Engineering / New Product
Development activities), as assigned.





Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

E:  saikiran.nandr...@w3global.com

A:  1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

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