Sr Staff Device Engineer

Takeda•Lexington, MA

21h•$137,000 - $215,270

About The Position

Takeda is seeking a Sr. Staff Device Engineer to serve as a subject matter expert and commercial device technical lead on the Commercial Device Engineering team. The role is accountable for technical aspects of the on-market combination product lifecycle, including change controls, manufacturing process validation, device complaints, design history file review, and post-market surveillance. The engineer will work with external CLOs and CMOs and collaborate with drug product, quality, regulatory, program leadership, and other cross-functional partners within Drug Product Device Development. The role supports lifecycle management of commercial combination products and their manufacturing processes, including technical investigations, qualification, technology transfer, commercial expansion, and resolution of product issues. The engineer will provide technical input to change controls, medical device reporting, and post-market surveillance; lead gap assessments and remediation when needed; and guide risk management activities. Responsibilities also include complaint handling, design control activities, specification development, design verification and validation, design transfer, manufacturing expansion, and process validation, while ensuring compliance with applicable regulations, standards, and Takeda policies.

Requirements

PhD in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with at least 3 years of relevant experience; or a master's degree with at least 5 years; or a bachelor's degree with at least 8 years.
Subject matter expertise in medical devices, particularly drug delivery systems, and technical leadership managing commercialized devices such as prefilled syringes, pen injectors, autoinjectors, and needle safety devices.
Knowledge of design controls and quality system requirements.
Technical expertise in combination product lifecycle management, including complaint handling, change control, manufacturing expansion, and quality and regulatory support.
Knowledge and application of cGMP requirements and demonstrated application of relevant industry guidance, standards, and regulatory combination product guidance.
Strong problem-solving, communication, and cognitive skills.
Good understanding of manufacturing processes and packaging construction methods.
Ability to work in a team, fulfill commitments, and manage multiple stakeholders.
Experience drafting portions of combination product technical content.
Ability to author user requirement specifications, technical protocols, reports, and assessments.
Previous project team experience with technology transfer.
Hands-on experience with concept development and feasibility testing, test method development, and test method validation.
Technical leadership experience with high-performing teams; ability to meet timelines, work cross-functionally, and advise key stakeholders.
Experience in medical device lifecycle management, including change controls, device complaint investigations, and post-market surveillance.

Responsibilities

Serve as the commercial device technical lead for cross-functional lifecycle management of commercial combination products.
Conduct technical investigations and analyze technical aspects of manufacturing processes and commercial expansion.
Oversee commercial device qualification processes and coordinate transfer of verification and validation for new drug delivery devices.
Resolve technical issues related to commercial products.
Provide input to change controls, medical device reports (MDR), and post-market surveillance reports.
Lead gap assessments and remediation as needed, and guide technical aspects of risk management activities.
Lead product projects within budget for defined activities.
Handle complaints, including subject matter expert evaluation, root cause analysis, CAPA, and change control.
Perform design control activities, including specification creation, design verification and validation, design transfer, and generation of test protocols and reports.
Support manufacturing expansion and process validation.
Ensure compliance with applicable device and combination product regulations and Takeda policies.
Work closely with drug product, quality, regulatory, program leadership, and external CLOs and CMOs.
Review design history files (DHF) and support quality and regulatory activities for on-market products.