Principal Systems Engineer- MedTech

Delve is seeking an industry-savvy Principal Systems Engineer to guide product development within the highly regulated and technically complex medical device landscape. Our work spans a wide range of products and technologies, and we’re looking for a change agent who is comfortable navigating ambiguity, adapting to evolving requirements, and guiding both internal and external teams toward successful outcomes in patient care.

While project team members may phase in and out over the course of a program, the Systems Engineer provides steady leadership from early scoping through design transfer. If you balance high-level strategy with hands-on execution, help teams zoom in and out of the system view, and create tools and frameworks that enable shared understanding, we’d love to hear from you. Join us as we continue to grow Delve’s Systems Engineering capability.

• Define system architecture, architectural decomposition, and subsystem allocation; indirectly lead cross-functional teams of designers, engineers, and technicians to deliver technical project outcomes
• Identify, assess, and manage technical risks using a data-driven approach; partner with project leadership to prioritize mitigation strategies and lead trade-off discussions balancing stakeholder needs, manufacturability, serviceability, quality, and cost
• Translate user needs, regulatory requirements, and commercial standards into tailored systems frameworks, requirements, and specifications; establish and maintain design traceability using digital tools
• Provide systems engineering leadership (e.g., interface specifications) to guide design inputs and objectively evaluate outputs across hardware, software, firmware, digital, and industrial design teams
• Collaborate with Program Management and Quality to create and maintain product development plans and ensure achievement of program milestones, including the creation and review of design control artifacts in alignment with applicable QMS requirements
• Represent Quality Engineering stakeholder needs (Delve and/or client), ensuring compliance across regulatory, clinical, marketing, and design partners and contributing to a robust Design History File (DHF)
• Lead planning and execution of design verification and validation; support Industrial Design and Human Factors teams in defining feature sets for formative and summative studies
• Build trusted client relationships through presentations, design reviews, workshops, and ongoing collaboration

• Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, or related field)
• 10+ years of experience in the medical device industry
• Experience developing FDA-regulated Class II and/or Class III electromechanical devices (or equivalent design-controlled products)
• Experience in clinical and/or patient-care settings
• Familiarity with regulated industry standards such as ISO 13485 and IEC 62304
• Ability to travel up to 10% domestically

What we are looking for: 

• An experienced systems engineer with a background in Class I medical devices and familiarity with model-based systems engineering, including a working knowledge of SysML or similar tools 
• A collaborative partner who thrives in multidisciplinary teams across early- and late-stage development, including manufacturing and design transfer
• A consultant with a strong customer-centric mindset and ability to effectively scope work
• A subject matter expert who can distinguish between project and user needs, formulate strategies, and lead teams to successful outcomes
• A professional committed to high standards of quality, rigor, and craftsmanship
• A self-motivated individual who can work independently with minimal oversight
• An excellent communicator with strong writing, presentation, and interpersonal skills
• A team member with an inclusive mindset who models people-centered behaviors across the organization