About this role:
The Senior R&D Engineer’s key role is responsible for electro-mechanical system design, CAD, procurement, Qualification/functional delivery. You will work with Process, Analytical, and Formulation teams to deliver prototypes and manufacturing systems for DEC’s company strategy. Our teams translate new products from lab-scale, into production to support clinical trial, and then scale-up for commercial supply. You will work with the Chief Scientific Officer and other Executive to guide new product into production, liaising with customers and regulators to minimise product risk, and ensure project milestones are delivered.
Requirements:
- Bachelor’s or Master’s degree, or PhD in a relevant engineering discipline, plus
- >5 years of relevant industry experience
- Computer Aided Design (CAD) – high competence in 3D CAD software use such as SolidWorks
- Engineering measurement
- Mechanical assembly design
- Strong skills in writing technical reports and verbally communicating technical content in oral presentations
- Experience working in multi-disciplinary projects for medical product development
- Competent and proficient in Windows, Internet, Microsoft Office to include Word, Excel, PowerPoint, and Outlook
Desired skills:
- Plastic injection moulded part design for manufacture
- Plastic injection moulded tool design
- Experience in the process of regulatory submission for the registration or a medical device of pharmaceutical
- product
- Drug formulation experience
- Polymeric composite compounding/processing
- Experimental design (e.g. Design of Experiment)
- Understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations
- and Current Good Manufacturing Practices (cGMPs)
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