Design and Development-Pen Technology Engineer

Job Title: Design and Development- Pen Technology Engineer.

Location: Bangalore

Experience: 3+ Yrs.

Qualification: mechanical engineering, precision engineering, mechatronics, medical technology, or similar education/experience.

Skillsets: 3D CAD/SolidWorks, EU MDR, Medical Device, tolerance analysis, mechanical design.

Responsibilities:

Ownership of design throughout development phase from design input to design verification. Definition of technical specifications for product functions and design of products according to specifications by owning the deliverable according to the Design Control Process.

• Creation of Product Design Specification
• Component and assembly design in the regulated environment of medical devices with support of CAD software
• Tolerance analyses
• Calculations
• Material selection
• Definition of functional tests
• Creating of drawings
• Article master data
• Bill of Material
• Testing and approval of components and assemblies
• Responsibility for product verification
• Carrying out root cause analyses
• Processing of design changes

Cross-functional activities and responsibilities:

• Core team member of the internal project team
• Cross-departmental support for engineering tasks
• Technical support of quotation requests for development services, operating resources and components and triggering of demand notifications
• Technical interface to external development partners, suppliers, and customers

Performing of activities within risk management:

• Responsibility for design FMEA
• Collaboration in user and process FMEA
• Technical support for complaints processing

Lives the medmix values:

• Customer Focus – Works with PM to organize tasks. Can present results of those tasks to the customer.
• Sustainable Innovation – Proposes innovative solutions to challenges within assigned work.
• Quality and accountability - Can provide effective solutions with minimal oversight.
• Trust and Teamwork - Actively communicates within team to advance the project.

Demands on the holder of the position:

• Completed studies in a technical field (e.g. mechanical engineering, precision engineering, mechatronics, medical technology) or similar education / experience.
• At least 3 years of professional experience in the development of medical devices
• Proficient in mechanical design and tolerance analysis
• Good knowledge of design with plastics (especially injection molded plastics)
• Proficient knowledge of 3D CAD systems, ideally SolidWorks
• Quality mindset with knowledge of relevant regulations, quality standards and technical norms such as EU MDR, 21 CFR 820, 21 CFR 4, ISO 13485, ISO 11608, and ISO 14971
• Proficient in the use of MS Office applications
• Proficient in English, both written and spoken