Expert – Infusion Pump

Job Purpose

To lead the design, development, and validation of infusion pump systems and related drug delivery devices for parenteral generic products. This role ensures the safe, effective, and compliant integration of device and drug components, supporting global regulatory submissions and commercialization of combination products. The expert will drive innovation, cross-functional collaboration, and technical excellence in infusion technologies tailored to therapeutic needs. 

Key Responsibilities:

. Device Design & Development

• Define scope and objectives for infusion pump projects, including reusable and disposable systems.

• Evaluate reference listed devices (RLDs) and develop compatible delivery systems for generic formulations. Job Information

• Ensure mechanical, material, and functional compatibility between drug and device components.

• Guide design of device assembly and packaging machinery, including URS, FAT, and qualification.

2. Testing & Verification

• Lead functional, environmental, and transport simulation testing per ISO 11608, ISO 10993, ASTM D4169, and ISTA standards.

• Ensure robust performance of infusion pumps under varied conditions (e.g., temperature, flow rate, back pressure).

• Prepare comprehensive testing reports for internal review and regulatory submissions.

3. Documentation & Regulatory Compliance

• Oversee creation of Design History Files (DHF), risk assessments (FMEA, FTA), and usability studies.

• Ensure compliance with FDA 21 CFR Part 820.30, ISO 13485, EU MDR, and QMSR.

• Support regulatory submissions and agency communications (IR, DRL, CRL) for combination products.

4. Quality & Risk Management

• Conduct extractables and leachables studies for primary containers.

• Review printed packaging and IFU for regulatory alignment.

• Lead change control, deviation handling, and audit readiness for device-related activities.

5. Cross-functional & External Collaboration

• Liaise with internal teams (FR&D, RA, QA, QC, Manufacturing, SCM) and external partners (vendors, notified bodies, testing labs).

• Provide device expertise during site audits and regulatory inspections. Qualifications, Experience , Skills & Attributes

Education: Bachelor’s in Biomedical, Mechanical, Industrial Design, or Materials Engineering; Postgraduate diploma in Packaging Technology preferred

Experience: 12+ years in drug delivery device and packaging development

Specialization: Proven expertise in infusion pump systems, combination product development, and regulatory documentation

Skills & Competencies:

• Engineering & Design: Advanced knowledge of infusion pump mechanics and materials

• Regulatory Knowledge: Familiarity with global standards for combination products

• Design Controls & Risk Management: Proficient in FMEA, DHF, and usability engineering

• Project Management & Collaboration: Strong leadership in cross-functional and vendor coordination

• Quality Assurance: Expertise in device testing, packaging, and compliance documentation