Sr Staff Device Engineer
Takeda
Summary
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.
Job description
About the role
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.
How you will contribute
- 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.
- Quality regulation system, DHF, MDR, ISO13485, ISO14971.
- Ensure 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 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.
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.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Annual Retirement Contribution Plan
- Health & Wellness Programs
- Onsite Flu Shots
- Health Screenings
- Generous Vacation Time
- Option to Purchase Additional Vacation
- Community Outreach Programs
- Charitable Contribution Match
- Family Planning Support
- Flexible Ways of Working
- Tuition Reimbursement
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.