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# Systems Engineer / Project Lead

- **Company:** ENTEGEE, Inc.
- **Location:** Bexley, OH, United States
- **Experience:** Expert
- **Salary:** $145,600.0 - $166,400.0
- **Contract:** Temporary to permanent
- **Skills:** Systems Engineering, Verification and Validation (Software)
- **Published:** October 26, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=3ea16fa7a188e5de

## About the Role

We are seeking an experienced Systems Engineer with medical device industry experience to lead and support medical device development, regulatory, verification, and validation (V&V) projects. The ideal candidate will bring strong project management and leadership skills, technical expertise, and the ability to manage client-facing projects with minimal supervision., * 7+ years of medical device regulatory and product development experience.

 * Bachelor's degree in Engineering, preferably Biomedical, Mechanical, Electrical, Systems, or a related discipline.
 * Demonstrated experience leading projects with minimal supervision.
 * Strong project management skills, including scope, schedule, budget, and resource management.
 * Experience with medical device verification and validation (V&V) activities.
 * Ability to develop and review technical documentation, requirements, risk assessments, regulatory strategies, and verification protocols.
 * Excellent client-facing, communication, organizational, and problem-solving skills.
 * Proven leadership abilities, strong follow-through, and the ability to coordinate cross-functional teams.
 * Ability to balance hands-on technical work with strategic planning and project oversight.
 * Willingness to work onsite in Columbus, Ohio.

Preferred Qualifications

 * Experience developing proposals, statements of work, and project budgets.
 * Experience mentoring engineers and providing technical guidance to project teams.
 * Strong understanding of medical device quality systems and regulatory expectations.
 * Experience managing multiple customer projects in a consulting or client-service environment.
 * Demonstrated ability to identify project risks, manage competing priorities, and maintain strong customer relationships.

## Description

Project Leadership & Management

 * Lead medical device development and regulatory projects from planning through execution and delivery.
 * Manage project scope, schedules, budgets, resources, and deliverables to ensure successful project outcomes.
 * Establish clear roles and responsibilities, allocate tasks, and coordinate cross-functional project teams.
 * Proactively monitor project progress, identify risks, and escalate issues that may affect product safety, project performance, or delivery timelines.
 * Track project budgets and obtain client approval for budget extensions before exceeding approved limits.
 * Provide timely project updates, communicate milestones, and manage client expectations.
 * Provide constructive feedback, mentoring, and guidance to team members.

Medical Device Development & Regulatory

 * Lead and support medical device product development and regulatory initiatives.
 * Develop, review, and maintain technical documentation, including:
 * System and product requirements
 * Risk assessments and risk management documentation
 * Regulatory strategies and supporting documentation
 * Verification and validation protocols and reports
 * Other product development and quality system deliverables
 * Plan, coordinate, and support verification and validation testing activities.
 * Ensure project deliverables comply with applicable medical device regulations, quality system requirements, and internal quality guidelines.
 * Identify and communicate technical, regulatory, and quality risks throughout the product development lifecycle.

Client Engagement & Business Development

 * Serve as a primary point of contact for clients, building trusted relationships through clear communication and dependable project execution.
 * Facilitate client meetings, technical discussions, project reviews, and decision-making sessions.
 * Develop proposals, project plans, and statements of work (SOWs) for new and existing customers.
 * Identify opportunities to develop new customer relationships and expand existing business.
 * Support business development activities both within active projects and through other professional avenues.
 * Contribute to a collaborative, client-focused, and values-driven team culture.