Principal System Engineer- MedTech

Delve; Philadelphia (Philadelphia County); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Student loan assistance

Tuition assistance

Disability insurance

Job summary

A product innovation services firm is looking for an industry-savvy Principal Systems Engineer in Philadelphia. This role involves leading product development in a complex medical device landscape. Key responsibilities include defining system architecture, managing technical risks, and ensuring compliance with regulatory standards. Applicants should have a Bachelor's degree in engineering and over 10 years of experience in the medical device industry. The company offers full-time positions with benefits, including medical insurance and tuition assistance.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical engineering, or a related field.
• 10+ years of experience in the medical device industry.
• Experience in clinical and/or patient care settings.
• Familiarity with ISO 13485 and IEC 62304.
• Ability to travel up to 10% domestically.

Responsibilities

• Define system architecture and indirectly lead cross-functional teams.
• Identify and manage technical risks using data-driven approaches.
• Translate user needs and regulatory requirements into tailored systems frameworks.
• Provide systems engineering leadership across hardware, software, firmware, and industrial design.
• Collaborate with Program Management and Quality to align design controls with QMS.
• Represent stakeholder needs and ensure regulatory, clinical, and design alignment in DHF.
• Lead design verification and validation planning, helping design teams define features.
• Build client relationships through reviews, workshops, and ongoing collaboration.

Skills

System architecture

Regulatory compliance

Risk management

Cross-functional leadership

Model-based systems engineering

Education

Bachelor’s degree in engineering

Tools

SysML

Job description

Position Overview

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.

Responsibilities

• 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

Requirements

• Bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, or related field)
• 10+ years of experience in the medical device industry
• 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

Preferred Qualifications

• 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

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.

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Consulting

Industries

• Business Consulting and Services

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Paid paternity leave
• Paid maternity leave
• Student loan assistance
• Tuition assistance
• Disability insurance

Equal Opportunity Statement

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.