Device Engineering Group Lead

Takeda•Lexington, MA

3d•Onsite

About The Position

OBJECTIVES/PURPOSE: Lead, mentor, and develop the Injection Systems Development device engineering team to strengthen technical capability, execution discipline, and talent growth. Drive consistency in the application and evolution of device platforms, design standards, and Design Control/DHF expectations across programs and partners. Assure robust, compliant device/combination product solutions by guiding risk management and verification/validation strategy and driving data-based technical decisions. Partner with internal stakeholders and external development/manufacturing partners to align user needs, requirements, and execution plans, ensuring timely delivery of robust platform-based solutions.

Requirements

Bachelors Degree and 12-15+ years relevant industry experience, or Masters Degree and 10-13+ years relevant industry experience, or Ph.D. 5-7+ years relevant industry experience.
Demonstrated ability to lead and develop technical engineers (coaching, performance feedback, delegation, and talent development).
Expert-level competency in Design Control/DHF execution and quality (requirements, risk management, V&V, traceability) and ability to audit/coach teams and partners on expectations.
Strong stakeholder management and communication skills to influence cross-functional decisions and manage external partner performance (design/development, manufacturing, labs/CRO/CMO) to schedule and quality.

Nice To Haves

Recognized device/combination product SME; deep expertise in drug delivery system development from feasibility through qualification and launch readiness.
Applies and coaches Design Control and DHF deliverables (21 CFR 820, ISO 13485) including requirements/specification development, V&V, and statistically sound verification protocols and reports.
Strong working knowledge of risk management (ISO 14971), design validation and Human Factors support, and deviation/complaint/failure investigations to drive robust technical recommendations
Manages the preparation of device/combination product CMC sections for global regulatory submissions.
Provides functional leadership for a team of ~10 device engineers; sets expectations, prioritizes work across multiple programs, mentors and develops capability.
Leads project and technical direction for cross-functional teams through clinical development, registration, and launch readiness; communicates clearly to multidisciplinary audiences.
Drives continuous improvement of design control practices and ways of working; influences internal stakeholders and external partners to adopt agreed standards and deliverables.
Identifies and leads departmental/functional initiatives.
Makes day-to-day technical and execution decisions across multiple projects (test strategy, requirements maturity, V&V approach, DHF completeness) and escalates high-impact trade-offs as needed.
Evaluates complex drug delivery system issues and data; provides clear go/no-go recommendations, defines mitigations, and leads/assists investigations to resolve deviations and test failures.
Partners closely with internal stakeholders (Quality, Manufacturing, Regulatory, Drug Product development, Clinical, Legal) to align technical deliverables, timelines, and compliance expectations.
Establishes and maintains strong working relationships with external design/development and manufacturing partners, service providers, testing laboratories, CROs, and CMOs.
Develops fit-for-purpose feasibility and verification strategies and encourages technically rigorous, data-driven experimentation to retire risk early.
Builds organizational capability by coaching best practices (e.g., applying In-Silico first principles and DFSS where applicable), codifying lessons learned, and sharing knowledge across programs and with partners.
Manages technical execution across a portfolio of device/combination product programs in parallel, balancing competing priorities, schedules, and resource constraints.
Operates within a highly regulated, global standards environment (FDA, ISO, AAMI/ANSI) and a complex external partner network, requiring disciplined documentation and alignment across organizations.

Responsibilities

Provide functional leadership for the device engineering team (~7-10 engineers), including prioritization, coaching/mentoring, and performance support.
Provide project and technical leadership to cross-functional teams to progress device/combination product programs through clinical development, registration, and launch readiness.
Ensure projects and team deliverables meet Design Control and DHF expectations in accordance with applicable regulations and standards.
Facilitate consistent application of platform-based design solutions, requirements, and best practices across pipeline programs by sharing lessons learned and aligning teams and partners on standard approaches.
Direct development and review of statistically sound design verification protocols/reports and support design validation activities.
Establish and maintain effective working relationships with external design/development, manufacturing, and service partners to ensure aligned scope, quality, and timelines.
Support continuous improvement of design control processes and documentation practices to maintain compliance with medical device and combination product regulations.