Eli Lilly is Hiring | Senior Associate Manager |

Position – Senior Associate Manager – Device Development Engineer, DDRD
Eli Lilly
Location – Bengaluru, Karnataka

Key Objectives/Deliverables

Provide Mechanical/Electromechanical design engineering technical expertise, and ensure that device design concepts are based on sound design engineering principles utilizing the latest engineering tools/technologies
Evaluate finite element analysis, tolerance stacks, manufacturing processes and scale-up, mold flow analysis, DOE, etc.
Assess and evaluate design concepts for technical risk and DFx (manufacturability, reliability, assembly). This includes ultrasonic welding, gluing, and snap fits for plastic device components.
Interact with internal and external design partners to enable project progression from clinical development through commercialization.
Work collaboratively with cross-functional teams to accelerate time to market of patient-centered drug delivery system designs
Coordinate device risk assessments and design control deliverables
Perform data/statistical analysis for packaging component and container closure system testing (functional and dimensional)
Stay abreast of regulatory and compendial requirements for packaging components and drug delivery devices

This individual is responsible for:

Ensuring thorough design risk assessments and risk management activities are conducted and acted upon,
Ensuring appropriate formal approval of required risk assessment documentation is accomplished,
Ensuring all required applicable design control deliverables are completed,
Writing technical reports, work instructions, change control documentation, and development plans
Authoring or coordinating the creation of process and design FMEA reports
Authoring design verification and design validation plans and reports
Authoring experimental protocols, conduct experiments, and analyze results
Develop and participate in building system and sub-system requirements
Preferred experience with syringes and needles

Basic Qualifications

Bachelors or Master’s in Engineering (Mechanical, Materials, or Biomedical Engineering) with at least 5 years of relevant experience.

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