Overview
On Site
Full Time
Skills
Testing
ISO 9000
Risk Analysis
Verification And Validation
Development Testing
Regulatory Compliance
ISO 13485
Collaboration
Manufacturing
Product Development
Product Lifecycle Management
Research and Development
Medical Devices
Biomedicine
Mechanical Engineering
Design Controls
Risk Management
FMEA
SolidWorks
Test Equipment
Documentation
Communication
Job Details
Job Description:
We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to commercialization.
Responsibilities:
We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to commercialization.
Responsibilities:
- Design and develop medical devices and components from concept to production.
- Create design inputs, outputs, risk analysis, and test protocols.
- Perform design verification and validation (V&V) activities.
- Support prototype development, testing, and documentation.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and IEC 60601.
- Collaborate with quality, manufacturing, and regulatory teams throughout the product development lifecycle (PDLC).
- 3-7 years of experience in R&D within the medical device industry.
- Bachelor's or master's in biomedical, Mechanical, or related Engineering field.
- Strong knowledge of design controls, V&V, risk management (FMEA).
- Experience with CAD tools (e.g., SolidWorks) and lab testing equipment.
- Familiarity with biocompatibility, sterilization, and material selection.
- Strong documentation and communication skills.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.