Engineer / Sr. Engineer - Research & Development (New Product Development)

• New products development and support sustenance activities for existing products using design control process.
• Hands on experience in functional and simulated use tests of medical devices, test methods, development and knowledge on maintenance of lab equipment, calibration is desirable.
• Understanding & good knowledge of various standards such as ISO 13485, ISO 14971, ISO 3826, ISO 10993, ISO 15223 etc.
• Ability to perform Gap assessment for standards and prepare equivalency reports. Experience in facing regulatory body audits on design control process would be beneficial, but not mandatory.
• Identify the problem and perform root cause analysis for failures. Knowledge in analysis using QC tools would be highly beneficial.
• Support Design verification activities with protocol and report preparation.
• Statistical analysis of data for investigating trends, patterns, and relationships using quantitative data.
• Preparation and periodic update of labels, drawings and specifications as and when necessary for both local and global sites.
• Working collaboratively with all stakeholders in Penpol operations team and from other R&D sites across the globe.
• Create and update standard operating procedures (SOP) employed in new product development.
• Support prototype, sample and design verification builds and coordinate activities with other departments including production, planning, procurement, stores, logistics etc.
• Good understanding of product life cycle management

Software: AutoCAD, SOLIDWORKS, Minitab, CorelDRAW, MS office, Excel

Qualification: Bachelors or Masters degree in Engineering or Science

Experience: 1-8 years in Medical device industry, preferably involved in design and development