Vasai Maharashtra Biomedical engineering Jobs – 2 Open Jobs Today

Production Engineer - Medical Device
Aviyana Ventures Pvt Ltd —Vasai, Maharashtra
- Up to ₹40,000 a month
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
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11d
Biomedical Engineer
HVS —Borivali H.O, Mumbai, Maharashtra
- ₹10,921.60 - ₹30,000.00 a month
- Full-time
- Microsoft Office
- Analysis skills
- Bachelor's degree
- Paid time off
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13d

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Production Engineer - Medical Device

Aviyana Ventures Pvt Ltd
Vasai, Maharashtra

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Job details

Permanent | Full-time
Up to ₹40,000 a month
11 days ago

Qualifications

GD&T
Master's degree
Analysis skills
Bachelor's degree
Product development

Full job description

Job Summary

We are looking for a skilled Product Engineer – Medical Devices to support the design, development, testing, validation, and improvement of medical device products. The role will work closely with R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Supply Chain teams to ensure products meet performance, safety, quality, and regulatory requirements.

Key Responsibilities

Design and develop new medical device products and components based on product and clinical requirements.
Convert product requirements into engineering specifications, drawings, prototypes, and design outputs.
Prepare and maintain BOMs, engineering drawings, specifications, design files, and technical documentation.
Support the complete product development lifecycle from concept and prototyping through verification, validation, transfer, and commercialization.
Conduct product testing, verification, validation, reliability testing, and performance evaluation.
Work with the Quality and Regulatory teams to ensure compliance with applicable medical device standards and regulations.
Support Design Control activities, including design inputs, outputs, reviews, verification, validation, and design changes.
Participate in risk management activities, including FMEA and risk analysis.
Identify product defects, investigate failures, and perform root-cause analysis.
Implement corrective and preventive engineering improvements.
Support manufacturing teams during Design Transfer and production scale-up.
Work with suppliers on component development, technical specifications, qualification, and quality issues.
Evaluate materials, components, manufacturing processes, and alternative designs.
Drive product improvements related to performance, reliability, usability, manufacturability, and cost.
Support engineering change requests, ECO/ECN processes, and product configuration management.
Analyze field complaints, customer feedback, and product performance data to identify improvement opportunities.
Prepare technical reports, test protocols, test reports, and other engineering documentation.
Participate in internal and external audits when required.
Ensure all product development activities are properly documented and traceable.

Regulatory & Quality Knowledge

Candidate should have exposure to relevant medical device requirements such as:

ISO 13485 – Quality Management Systems for Medical Devices
ISO 14971 – Medical Device Risk Management
IEC 60601, where applicable to electrical medical devices
Design Control and Design History File (DHF)
Device Master Record (DMR)
Verification & Validation (V&V)
Design Transfer
CAPA and Non-Conformance
Change Control / ECO / ECN
Supplier Qualification
Regulatory documentation and compliance

Candidate Profile

Bachelor's/Master's degree in Mechanical, Biomedical, Electronics, Electrical, Mechatronics, or a relevant engineering discipline.
2–6 years of experience in medical device product development, R&D, product engineering, or design engineering.
Experience with medical devices, healthcare products, surgical instruments, implants, diagnostic devices, or related products preferred.
Good understanding of engineering drawings, CAD, materials, manufacturing processes, and product testing.
Working knowledge of Design Control, Risk Management, Verification & Validation, and Design Transfer.
Knowledge of ISO 13485 and ISO 14971 preferred.
Strong analytical, troubleshooting, documentation, and problem-solving skills.
Ability to work effectively with cross-functional teams.
Strong attention to detail and quality mindset.

Preferred Skills

CAD/3D modelling
GD&T
Medical device design and development
Product testing and validation
Design verification and validation
Risk analysis / FMEA
Root Cause Analysis
Design Transfer
Engineering Change Management
Supplier Development
ISO 13485
ISO 14971
Technical documentation

Key Performance Indicators (KPIs)

Product development timelines
Successful verification and validation
Product quality and reliability
Design-change effectiveness
Manufacturing issue resolution
Cost optimization
Documentation accuracy and completeness
Risk reduction
Successful design transfer to manufacturing

Pay: Up to ₹40,000.00 per month

Work Location: In person

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Production Engineer - Medical Device

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