Senior Research And Development Engineer

> Role Objective

A key objective of this position is to support research and development activities related to medical devices and their delivery systems. The role focuses on product design, development, validation, documentation, and compliance with quality and regulatory standards, while ensuring timely execution of R&D projects and continuous improvement in product quality and processes.

> Desired Candidate Profile

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Relevant experience in medical device R&D, preferably involving IOLs or delivery systems.
• Hands-on experience with CNC machining and mechanical assembly for prototype or R&D production.
• Strong knowledge of ISO 13485, QMS, EDMS, and medical device regulatory requirements.
• Experience in design validation, process validation, and stability studies.
• Proficient in CAD software and technical documentation.

> Roles & Responsibilities

1) R&D Operations and Product Development

• Work closely with the R&D team on the development of IOLs and IOL delivery systems.
• Operate CNC machines for R&D production and perform mechanical work at R&D workstations.
• Design IOLs, injector cartridges, molded parts, blades, and other components, and generate CAD files.
• Support R&D batch planning, part production, assembly, testing, and quality control activities.
• Support commercial product stability function testing as required.

2) Design Control, Validation, and Compliance

• Prepare and maintain ISO design documents and design files for injectors and other components.
• Support ISO compliance activities and perform required tests for delivery systems.
• Conduct validation activities for delivery systems and components, including functional testing and reporting.
• Execute IQ, OQ, and PQ activities and prepare related documentation.
• Support sterilization validation, stability testing batches, and R&D stability study initiation and execution.

3) Quality Systems and Documentation

• Support QMS and EDMS implementation from the R&D function.
• Periodically review R&D SOPs and ensure timely updates.
• Prepare SOPs, BMRs, RMS documents, drawings, quality plans, IFUs, KLDs, and blister drawings.
• Handle BIBO reports and TrackWise activities, including CCNs, action plans, and PR closures.

4) Cross-Functional and Vendor Coordination

• Create PRs and GRNs and manage incoming QC checks.
• Coordinate vendor identification, quotations, follow-ups, vendor code creation, and payment follow-ups for R&D.
• Prepare required drawings and artwork for marketing, internal stakeholders, and external vendors.

5) Planning, Budgeting, and Execution

• Support preparation of R&D budgets, expense tracking, and payment planning.
• Create new internal orders (IOs) and obtain approvals for PRs.
• Ensure R&D order execution as per committed timelines.

6) Continuous Improvement

• Improve the quality, functionality, and performance of IOL delivery systems.
• Establish protocols and processes for all stages of R&D projects, ensuring all changes and evaluations are properly documented.
• Perform any other duties as assigned by superiors from time to time.

> Functional Skills Required

• Medical device design and development.
• CNC machining and mechanical assembly.
• CAD design and technical drawings.
• Design control, validation, and testing.
• ISO 13485 and QMS compliance.
• Documentation management (SOPs, BMRs, validation protocols).
• TrackWise, EDMS, and change management systems.

> Behavioral Skills Required

• Strong attention to detail and documentation accuracy.
• Effective communication and cross-functional coordination.
• Problem-solving and analytical thinking.
• Ability to manage multiple tasks and meet deadlines.
• Team-oriented mindset with a proactive approach.
• High level of integrity and compliance orientation.

> Authority

• Authorized to conduct training related to IOLs and injector/cartridge delivery systems.
• Authorized to sign off on R&D-related documents.
• Authorized to approve new product release notes.
• Authorized to sign off functional test reports for IOL delivery systems.
• Authorized to share R&D documents with relevant internal users.

> Team Size to be Handled:

• Individual contributor role, reporting to the AGM R&D.

> Important Links:

• Website:

  https://biotechhealthcare.com/

• LinkedIn:

  https://www.linkedin.com/company/biotechhealthcare/

• Instagram:

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Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.