Position – Senior Associate Manager – Device Development Engineer, DDRD
Location – Bengaluru, Karnataka
- 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
- Bachelors or Master’s in Engineering (Mechanical, Materials, or Biomedical Engineering) with at least 5 years of relevant experience.