About the role

AI summarised

The Senior Engineer, Process Development role involves supporting new product introduction and production engineering in a regulated, high-volume environment. The engineer collaborates with R&D and cross-functional teams to develop manufacturable designs, improve processes, reduce costs, and increase yields. Responsibilities include applying technical expertise to solve complex problems, managing projects, and driving innovation through leadership and analytical thinking.

BiotechOnsite

Key Responsibilities

Work closely with R&D to develop Design-for-Manufacturing (DFM) processes for NPI, leveraging learning from existing products and providing feedback on material component selection and associated test plans
Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach
Works on assignments of diverse scopes where information is limited and problem solving requires adaptation of existing techniques
Adapts style to differing audiences and often advises others on difficult matters that require persuasion
Work is done independently and is reviewed at critical points
Uses evaluation, judgment, and interpretation to select best course of action

Requirements

Bachelor's Degree / Master's in Engineering/Science in Chemistry, Mechanical, Electrical, Biomedical, Material or a related field
Minimum 5 years of work experience, preferably in the biotech industry
Experience in FDA-regulated environment is a plus
Knowledge about wafer fabrication, biochemistry process, plastic engineering, or CMO Management will be an added advantage
Possess good understanding of manufacturing processes, methodologies and environment
Capable of defining test plans for components, materials and systems
Skilled in failure analysis of multiple reliability failure modes
Excellent Analytical, Problem Solving and Project Management skills
Good understanding of Quality Assurance and Process Control Knowledge
Excellent team player, interpersonal and communication skills
Able to work well under stress, both internally and across functions and perform multitasking
Proactive, innovative and self-motivating