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, excellent communication and cognitive skills.
• Good understanding of manufacturing process and packaging constructions methods. Ability to work in team, fulfills commitments and managing multiple stakeholders. Experience in drafting portions of combination product technical content. Proven ability to author user requirement specifications, technical protocols, reports and assessments. Previous project team…