Senior Project Engineer

CIVCO Medical Solutions; Coralville (IA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

CIVCO Medical Solutions in Coralville, IA seeks a Senior Project Engineer to lead large, complex programs integrating business, technical, regulatory, quality, and customer considerations.

The role mentors other engineers, reports to leadership, and drives improvements in project execution while ensuring compliance with design controls and regulatory standards across cross-functional teams.

Qualifications

• Demonstrated success leading large cross-functional projects with limited oversight.
• Strong knowledge of medical-device design controls, quality systems, regulatory considerations.
• Bachelor’s degree in engineering or related technical field; 6–12 years of relevant experience.

Responsibilities

• Develop and maintain project plans with scope, objectives, and timelines.
• Lead project meetings and document action items with timely completion.
• Identify risks and propose mitigation options to leadership.
• Collaborate with internal teams to apply structured problem-solving.
• Forecast resources and budgets, evaluate cost tradeoffs.
• Ensure design controls comply with standards and policies.
• Apply change management processes consistently.
• Prepare and deliver status updates to stakeholders.
• Lead executive and cross-functional communication, resolve conflicts.
• Mentor Engineer I/II and drive process improvements.

Skills

Cross-functional project leadership

Regulatory knowledge (FDA/EU)

Quality systems

Budget forecasting

Executive communication

Education

Bachelor’s degree in engineering or related technical discipline

Tools

Microsoft Project

SharePoint

Power BI

Job description

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.

Job Requirements:

• Project Planning: Develop and maintain project plans, including scope, objectives, and timelines. Ability to propose tailored project approaches (waterfall, agile, hybrid) based on understanding of scope and delivery target.
• Meeting Coordination: Organize, lead, and actively participate in project team meetings, ensuring action items are accurately documented, assigned, and completed on schedule.
• Risk Identification and Recovery: Monitor project progress against established plans, identify potential risks, and elevate concerns with prepared risk mitigation options promptly to leadership.
• Collaboration & Problem Solving: Partner with internal teams to apply structured problem‑solving methodologies to assigned tasks and project challenges.
• Resource & Financial Management: Develop credible resource and budget forecasts that frame opportunity‑cost, cost‑benefit, make‑or‑buy, dual‑source, and sequencing tradeoffs for leadership.
• Regulatory Compliance: Ensure all design control activities comply with applicable standards, regulations, and company policies.
• Quality & Change Management: Apply CIVCO’s quality and change management processes consistently and effectively across all responsibilities.
• Reporting & Communication: Prepare and deliver clear, timely project status updates for internal and external stakeholders.
• Stakeholder Leadership: 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.
• Mentorship & Process Improvement: 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Qualifications:

• 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.

Education and/or Experience:

• 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.

What Makes You Stand Out:

• 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.

What You Will Get:

At CIVCO, we empower our associates to develop their careers while furthering our mission to make image‑guided medical procedures safer. We offer competitive compensation, performance bonuses, and a complete benefits package starting day one — including company‑sponsored health plans, 401(k) matching, tuition reimbursement, paid leave, and more.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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