Sr Staff Device Engineer
About The Position
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 recognized 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.
Requirements
- 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 experience with technology transfer.
- Hands on experience with the concept development and feasibility testing, test method development and test method validation.
- Technical leadership for high performing teams, with strong ability to meet timelines, work effectively cross functionally and expertly advise key stakeholders.
- Experience in medical device LCM: change controls, device complaint investigations and post-market surveillance
Responsibilities
- Work as commercial device technical lead working with cross functional team to support lifecycle management of commercial combination product.
- 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.
- Ensured Compliance with appropriate device and combination product regulations and Takeda policies.
Benefits
- Medical, Dental, and Vision
- 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Flexible Ways of Working
- Tuition reimbursement
- up to 80 hours of sick time
- up to 120 hours of paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
