Job Opportunity: R&D – Product Development Engineer (Medical Devices)
Summary:
Mavoix Technology Solutions Pvt. Ltd. is seeking a highly motivated and detail-oriented R&D – Product Development Engineer to join our dynamic team in Bangalore. This is an excellent opportunity for a recent graduate or early-career professional with a passion for medical device development, verification & validation, and quality systems compliance. As an integral part of our R&D team, you will contribute to the design, development, and testing of innovative smart medical devices. If you’re eager to apply your engineering skills in a fast-paced, impactful environment, we encourage you to apply.
About Mavoix Technology Solutions Pvt. Ltd.:
At Mavoix Technology Solutions, we are dedicated to pioneering advancements in medical device technology. We are committed to developing innovative solutions that improve patient outcomes and enhance healthcare delivery. Our team consists of talented and passionate individuals who are driven to make a difference in the world of healthcare.
Job Description:
We are looking for an R&D – Product Development Engineer to contribute to the development and validation of our cutting-edge smart medical devices. This role offers hands-on experience in all aspects of the product development lifecycle, from design and testing to quality system compliance.
Key Responsibilities:
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Verification & Validation (V&V): Own and maintain Verification & Validation activities for smart medical devices, including PCB boards, simulators, phantoms, testing equipment, and hardware tools. This involves ensuring devices meet performance and safety requirements before release.
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Test Planning and Reporting: Develop detailed test plans, conduct testing, and generate comprehensive test reports and traceability matrices. These documents must be aligned with risk analysis and design control requirements.
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Compliance: Ensure adherence to Engineering Quality Procedures, Quality Management System (QMS), and regulatory expectations for global medical device markets (e.g., FDA, CE Marking). This includes staying up-to-date with relevant standards and guidelines.
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Manufacturing Process Validation: Support manufacturing process validation for New Product Introduction (NPI) projects, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This includes creating validation plans, defining sampling strategies, and generating detailed documentation.
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Documentation: Maintain ISO 13485-aligned documents, such as Medical Device File (MDF), Design and Development File (DDF), Device Master Record (DMR), and Batch Manufacturing Record (BMR). This ensures the integrity and traceability of product information.
Qualifications:
- Education: Bachelor’s or Master’s degree (BE/BTech/MTech/MS) in Biomedical Engineering or Medical Electronics.
- Experience: 0–2 years of relevant experience. Fresh graduates are encouraged to apply.
- Knowledge: Strong understanding of medical device quality systems (ISO 13485, 21 CFR Part 820), design control principles, and process validation methodologies.
- Skills:
- Excellent analytical and problem-solving skills.
- Strong written and verbal communication skills.
- Ability to work independently and collaboratively within a team.
- Proficiency in using testing equipment and software tools.
- Familiarity with regulatory requirements for medical devices.
Benefits & Perks:
- Competitive salary package, commensurate with experience.
- Hands-on exposure to medical device R&D, working with cutting-edge technologies.
- Opportunity to work with advanced smart devices and testing platforms.
- Mentorship and a strong learning and growth path in Verification & Validation engineering.
- A collaborative and supportive work environment.
Location:
- Bangalore (On-site)
Mavoix Technology Solutions Pvt. Ltd.
How to Apply:
Interested candidates are invited to apply through [Application Link]. Please submit your resume and a cover letter highlighting your relevant skills and experience.
We look forward to receiving your application!