Staff Engineer – Devices

Our client is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. They specialize in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company holds a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.

Our client operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a dedicated workforce of over 22,000 professionals.

The company is committed to improving patient health outcomes through its subsidiaries, which include Diagnostics, Digital Health, and Manufacturing Solutions.

Responsibilities:

Design & Development:

• Lead the design and development of drug combination products by understanding design space and managing critical design parameters.
• Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&T) to create sound engineering drawings.
• Identify the best tools and approaches to effectively solve engineering problems.
• Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.

Technical Support & Compliance:

• Support the evaluation and assessment of new technologies, intellectual property, products, and processes.
• Provide support for existing products in terms of quality, manufacturing, and cost improvement.
• Execute technical and cross-functional project work to ensure successful product development.
• Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.
• Collaborate effectively with laboratory technicians and support staff.
• Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.

Requirements:

Regulatory & Validation Expertise:

• Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).
• Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3

Experience:

• Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.
• Strong understanding of disciplined product development processes and quality requirements.
• Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.
• Proficiency in SolidWorks is required.

Skills & Competencies:

• Strong interpersonal skills with the ability to collaborate effectively.
• Excellent technical judgment and problem-solving abilities.
• Demonstrated accountability for the successful completion of assigned tasks.