Senior Project Engineer

CIVCO Medical Solutions•Coralville, IA

20d•Hybrid

About The Position

The Senior Project Engineer leads CIVCO’s large, complex, and most visible projects or programs with limited oversight. This role integrates business, technical, regulatory, quality, customer, supplier, financial, and organizational considerations; brings clear recommendations to leadership; mentors other Project Engineers; and improves project execution practices. Senior Project Engineer is based out of our production facility in Coralville, IA. This position may have opportunities for flexible scheduling and part-time telecommuting based on business needs.

Requirements

Demonstrated success leading large or complex cross-functional projects with limited oversight.
Strong working knowledge of medical-device design controls, quality systems, regulatory considerations, verification and validation, risk management, project financials, and executive communication.
Bachelor’s degree in engineering or a related technical discipline preferred; equivalent relevant experience may be considered.
Typically 6-12 years of relevant experience, often including 3-5 years at the Project Engineer II level or equivalent demonstrated capability.

Nice To Haves

Familiarity with stage-gate or similar structured development frameworks.
Basic understanding of design verification/validation and regulatory considerations in product development (ISO 13485, 14971, 10993, etc.).
Experience with FDA and EU regulatory environments, human factors, supplier development, customer programs, or complex product-development portfolios.
Demonstrated mentorship and implementation of process improvements that strengthened project execution, forecasting, risk management, or cross-functional collaboration.
Experience using project governance and reporting tools such as Microsoft Project, SharePoint, and Power BI.

Responsibilities

Develop and maintain project plans, including scope, objectives, and timelines.
Organize, lead, and actively participate in project team meetings, ensuring action items are accurately documented, assigned, and completed on schedule.
Monitor project progress against established plans, identify potential risks, and escalate concerns with prepared risk mitigation options promptly to leadership.
Partner with internal teams to apply structured problem-solving methodologies to assigned tasks and project challenges.
Develop credible resource and budget forecasts that frame opportunity-cost, cost-benefit, make-or-buy, dual-source, and sequencing tradeoffs for leadership.
Ensure all design control activities comply with applicable standards, regulations, and company policies.
Apply CIVCO’s quality and change management processes consistently and effectively across all responsibilities.
Prepare and deliver clear, timely project status updates for internal and external stakeholders.
Manage executive, customer, OEM, and senior cross-functional communication; create clarity around decisions, risks, implications, and required actions; and lead through conflict, uncertainty, resistance, and competing priorities.
Mentor Project Engineer I and II employees, provide practical feedback, review plans and decision framing, model disciplined governance compliance, and lead department-level process improvements and training.