Senior Systems Engineer- MedTech

Systems Engineer

Delve is seeking an industry-savvy Systems Engineer to guide and drive 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. Your duties will include the development of high-level strategies along with the execution of technical deliverables. As part of a growing competency at Delve, you can articulate the way you work into a set of best practices to support the expansion of our Systems Engineering community of practice. If you balance high-level strategy with hands-on execution, help teams zoom in and out of the system view, drive decision making and product definition 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.

Responsibilities

• Define system architecture, architectural decomposition, and subsystem allocation; indirectly lead cross-functional teams of designers, engineers, and technicians to deliver successful technical & overall 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 sub-system specifications; establish and maintain design traceability and test plans to inform and enable successful verification testing
• 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 programs from concept development through verification and validation; support Industrial Design and Human Factors teams in defining feature sets and driving critical design decisions
• Build trusted client relationships through presentations, design reviews, workshops, and ongoing collaboration

Requirements

• Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, or related field)
• 10+ years of experience in the medical device industry, or 7+ years of experience with an advanced degree
• Experience developing FDA-regulated Class II and/or Class III electromechanical devices (or equivalent design-controlled products)
• Experience driving development of connected devices/products with both firmware and software
• Experience in clinical and/or patient-care settings
• Familiarity with regulated industry standards such as ISO 13485,IEC 62304, and IEC 60601
• Ability to travel up to 10% domestically

Preferred Qualifications

• An experienced systems engineer with a background in regulated medical devices and familiarity with model-based systems engineering, including a working knowledge of SysML, Helix, Jira and similar development and requirements management tools.
• A collaborative partner who thrives in multidisciplinary teams across early- and late-stage development, including V&V 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

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.