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Tek Support
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Research And Development Specialist

Research And Development Specialist

Tek Support

8 years

0 Lacs

bengaluru karnataka india

Posted:2 days ago| Platform:

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Skills Required

research development design verification engineering compliance analyze support risk management traceability documentation manufacturing cad prototype report data integrity controls solidworks test dfmea dfm communication

Work Mode

On-site

Job Type

Part Time

Job Description

We’re Hiring! – R&D Engineer (Medical Device / Pharma Equipment)

Location:

Work Type:

Experience Level:

About the Role

Research and Development Engineer

engineering precision with regulatory awareness

🔹 Key Responsibilities

Participate in
concept development, design, and prototyping
of new medical devices or process equipment.
Conduct
design verification and validation testing
, analyze results, and document findings per regulatory requirements.
Support
risk management activities (FMEA)
and ensure traceability throughout design and development phases.
Prepare and maintain
Design History Files (DHF), technical documentation, and change control records
.
Collaborate with cross-functional teams including
manufacturing, quality, and regulatory affairs
to ensure design transfer readiness.
Troubleshoot and improve existing product designs for
performance, manufacturability, and cost optimization
.
Apply
CAD/CAE tools
for design development and design modifications.
Ensure compliance with
ISO 13485, ISO 14971, and 21 CFR Part 820
design control requirements.
Coordinate with suppliers for prototype components and material evaluations.
Participate in
V&V protocol and report writing
, ensuring data integrity and documentation accuracy.

🎓 Qualifications

Bachelor’s or Master’s degree in
Mechanical, Biomedical, Industrial, or Materials Engineering
.
3–8 years of R&D or product development experience in
medical device or pharmaceutical equipment
industries.
Strong understanding of
FDA design controls, risk management, and quality systems
.
Hands-on proficiency with
CAD tools
(SolidWorks, Creo, or CATIA).
Experience in
design verification, validation, and test method development
.
Familiarity with
DFMEA, DFM/DFA, and tolerance analysis
.
Excellent documentation, problem-solving, and communication skills.
Working knowledge of
GMP, ISO 13485, and regulatory documentation practices
.

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