Deputy Manager - Medical Devices Process development

Role Summary : Medical Devices Process development

Responsible for leading the development and optimization of manufacturing processes for new drug delivery devices and combination products. This role encompasses pilot-scale manufacturing, process validation, design-for-manufacture collaboration, and coordination with internal teams and external vendors to ensure successful scale-up to full production while adhering to regulatory and quality standards.

Technical / functional skills / Experience :

Working Knowledge & understanding of medical device regulations like ISO13485, EU MDD / MDR & US FDA 21 CFR Parts 4 & 820 & standards requirements like IEC60601, ISO14971, IEC62366, ANSI / AAMI HE75 etc.

Possess a high level of integrity with a passion to work with entrepreneurial teams in a rapidly growing organization.

Hands on experience with various techniques including

Process flow design

Design For Manufacture / Design for Assembly

Assembly of plastic moulded parts

Automation and robotics

Part handling and feed systems

Process set up and control definition

Process risk management and validation protocol creation and execution

Experience on process development role, with time spent in both manufacturing and process development environment

Experience on vendor development for automation equipment and services

Understanding of medical device process design and regulatory processes

Strong collaboration, active listening & excellent written and verbal communication

Responsibilities :

Responsible for Manufacturing Process Development for new products within the Device R&D team, focusing on pilot scale manufacture and assembly of Drug delivery devices and combination products.

Work with internal functions and external vendors needed for all device process development activities and equipment.

Responsible to establish design related specifications into process automation requirements and controls

Work with product design & development teams regarding Design for Manufacture & Assembly to avoid major gaps during later execution phases

Responsible for execution of process development and manufacturability deliverables for each development life cycle phase.

Ensure all work is completed in accordance with the latest applicable regulatory requirements and international standard

Validate pilot scale processes for clinical trials and Design Verification, including in line testing where applicable.

Follow the established procedures for the execution of process development activities

Develop feasible plans for execution of activities with clear accountabilities, tasks and objectives.

Liaise with Manufacturing science and Technology (MSAT) and other manufacturing stakeholders to transfer knowledge, capability and documentation that facilitates successful scale up to full production. Support scale up activities during their execution.

Process risk management and validation protocol creation and execution.

Management of third-party suppliers of equipment and services.

Qualifications

BE / B. Tech / M. Tech in Mechanical Engineering or equivalent degree

10+ years of total industrial experience

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.