Director of Systems Engineering- MedTech

Director Of Systems Engineering

Delve is seeking a Director of Systems Engineering to define, lead, and scale our Systems Engineering discipline across studios. This role blends deep technical expertise with organizational leadership, operational excellence, and capability growth. As Director, you will shape the strategic direction of Systems Engineering at Delve. You'll strengthen our capabilities in system architecture, requirements management, risk engineering, and design controls — while building a high-performing, connected, and engaged team. You will serve as both a senior advisor on complex client programs and a steward of the discipline's long-term growth, ensuring our work remains rigorous, innovative, and competitive within the medical device landscape.

Responsibilities

• Serve as a senior advisor on complex, multi-disciplinary programs, guiding system architecture, risk management, and critical trade-off decisions.
• Provide executive-level technical oversight from early scoping through design transfer, ensuring architectural integrity and traceability.
• Support and mentor technical leads, helping teams navigate ambiguity while balancing user, regulatory, quality, and commercial priorities.
• Step into key engagements as needed to ensure delivery excellence and client confidence.

Vision & Capability Development

• Define and advance the strategic direction of the Systems Engineering discipline, aligning capabilities with emerging client and market demands.
• Establish scalable tools, frameworks, and best practices that create consistency and elevate technical rigor across studios.
• Drive innovation in systems methodologies, digital traceability, and risk management approaches.
• Strengthen cross-disciplinary integration, breaking down silos to enable seamless collaboration.

Talent Management & Development

• Build, lead, and develop a high-performing Systems Engineering team across studios.
• Coach and align department leaders around performance, career growth, and team health.
• Foster an inclusive, accountable culture that reflects Delve's values and commitment to excellence.
• Maintain a visible leadership presence within your studio and across the broader organization.

Delivery & Operational Guidance

• Guide operational planning, resourcing, and delivery processes to ensure scalable, compliant, and efficient execution.
• Leverage department metrics to inform staffing, pipeline forecasting, and performance improvements.
• Identify and mitigate risks to delivery quality, client satisfaction, or team capacity.
• Champion high standards in design controls, verification and validation (V&V) planning, and DHF integrity.

Growth & Commercial Success

• Build strong executive-level client relationships, particularly on large, complex medical device programs.
• Partner with Client Partners and Account Directors to scope opportunities and support business development efforts.
• Contribute to revenue growth and profitability through strategic staffing, proposal input, and portfolio shaping.
• Serve as an external ambassador for Delve's Systems Engineering expertise through thought leadership and industry engagement.

Requirements

• 12+ years of progressive experience in regulated medical device development, including leadership responsibilities
• 8+ years working in design consultancies
• Deep expertise in FDA design controls and relevant standards (ISO 13485, ISO 14971, IEC 62304, risk management frameworks)
• Experience developing Class II and/or Class III electromechanical or software-enabled medical devices.
• Demonstrated success leading multi-disciplinary teams
• Bachelor's degree in engineering; advanced degree preferred

Preferred Qualifications

What we are looking for:

• A strategic, people-focused leader with experience in new medical device product development
• Someone who thrives in collaborative environments and helps create them
• A collaborative partner who thrives working cross-functionally with product, design, hardware, human factors, quality, and regulatory teams in complex product development environments
• A consultant with a strong customer-centric mindset and ability to effectively scope work
• An excellent communicator with strong writing, presentation, and interpersonal skills
• A natural mentor who is hands-on, adaptable, and capable of balancing high standards with the space for learning and growing
• A leader with an inclusive mindset who models people-centered behaviors across the organization
• A professional committed to high standards of quality and craftsmanship

Be Inspired. Be Inspiring. Be yourself. Delve embraces difference because creativity, curiosity, and diversity drive innovation. We nurture a supportive and inclusive environment. Be yourself and create a future that improves lives. We encourage applicants of color and those with diverse lived experiences to apply. About Delve Delve is a product innovation services firm. We partner with ambitious teams to bring step change innovations to market in industries where the challenges are simultaneously complex, constrained, and consequential. By blending breakthrough creativity with rigorous de-risking and a deep focus on organizational alignment, we help our clients define, envision, and develop innovations that deliver real business impact. Delve operates studios in Boston, Madison, Philadelphia, and San Francisco, and partners with leading companies including Abbott, GE HealthCare, Google, Johnson & Johnson, Kohler, P&G, and Stryker. Learn more at Delve.com.