Systems Engineer / Project Lead

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.

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.

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

GRPB

Pay: $70.00 - $80.00 per hour

Expected hours: 40.0 per week, * 401(k)

• Dental insurance
• Health insurance