Device Engineering Group Lead

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.

ACCOUNTABILITIES:

• 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.

CORE ELEMENTS RELATED TO THIS ROLE:

• Leads and develops a team of device engineers to provide injection system combination products for subcutaneous drug formulations.
• Provides technical governance and consistency across multiple device/combination programs, rather than driving development for a single asset.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• 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.

Leadership

• 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.

Decision-making and Autonomy

• 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.

Interaction

• 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.

Innovation

• 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.

Complexity

• 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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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.