Medical Device Process Development Engineer

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 :

Qualifications

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.