Sr Device Engineer

Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Sr. Staff Device Engineer where you will be recoganized as a device SME of combination product device on the Commercial Device Engineering (CDE) team accountable for all the technical aspects of the on-market combination product lifecycle management. You will also be responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products.

As part of the CDE team, you will report to Director, Commercial Device Engineering and work with external CLO and CMO.

The on-market combination products enhance patient and medical professional experiences with Takeda’s medicinal drug products. In particular, the Sr. Staff Device Engineer has experience in drug delivery devices/systems and understanding of manufacturing process in global standards for the combination products.

How you will contribute:

• You will work as commercial device technical lead working with cross functional team to support lifecycle management of commercial combination product.
• This CDE position is within Takeda’s Drug Product Device Development and will work closely with drug product, quality, regulatory, program leadership, etc. The successful candidate will work in a cross functional environment and establish strategic working relationships.
• Conduct technical investigations, analyze technical aspects related to the manufacturing processes and/or commercial expansion.
• Oversight of commercial device qualification processes, coordinate tech transfer of verification and validations related to technology transfer of new drug delivery devices, and solve technical issues related to commercial products.
• Provide input to change controls, MDR, and post-market surveillance reports.
• Lead gap assessments / remediation as needed and guide technical aspects of risk management activities. Lead products’ projects within budget for defined activities.
• Complaint handling including SME evaluation root cause analysis, CAPA, change control.
• Design control process, specification creation, design verification and validation, design transfer, test protocol and report generation.
• Manufacturing expansion, process validation.
• Quality regulation system, DHF, MDR, ISO
  13485, ISO
  14971.
• Ensured Compliance with appropriate device and combination product regulations and Takeda policies.

Minimum Requirements /

Qualifications:

• PhD degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with a minimum of 3 years of relevant experience;
  Master's degree with a minimum of 5 years of relevant experience; or Bachelor's degree with a minimum of 8 years of relevant experience.
• SME in medical devices, particularly drug delivery systems, with technical leadership to manage drug delivery device commercialized products such as PFS, pen injector, Autoinjector, Needle Safety Device, etc.
• Knowledge in design controls and quality system requirements.
• Technical expertise in combination product with focus on life cycle management including complaint handling, change control, manufacturing expansion, and quality and regulatory supports.
• Knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document and Regulatory combination product guidance documents applicable to the role. Strong problem solving skills,…