Project Manager, Systems Engineer, Operations Management

Location:
Madison, WI, On-site
Pay Rate: $60.00- $65.57/hr
Duration: 6 months+
Hours: 8-5pm , M-F , with OT as needed

Summary:
An international Pharmaceuticals and Medical Device manufacturer that has been managing complexity and improving lives since 1887 and distributing high quality drug delivery systems since early 2000. We offer a rewarding work environment with global opportunities while maintaining an employee-focused atmosphere. We are currently searching for a dynamic Technical Project Manager to join our Device Engineering and Operations team in Madison, WI.
Reporting to the Director of Engineering, the Technical Project Manager will be an engineering professional, responsible for leading technical projects through planning, scheduling, budget management, resource management for change control and stage gate projects in alignment with the department’s SOPs in a matrix of cross functional groups. Leads and delivers projects as a project management expert. Will be responsible for project planning and management along with all activities needed for product development projects in accordance with design controls.

Follows operating mechanisms for monitoring project progress and for intervention and problem solving through collaboration with other technical team members. Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost. Integrates with the project teams and facilitates discussions on technical and nontechnical problems throughout the life of the project. Oversees and coordinates work performed by outside contractors. Provides timely and accurate information and status updates to project stakeholders and management.

Participates in budget development and evaluating how project plan changes impact cost, resource requirements and schedule.

Essential Responsibilities:
Project Management

• Lead and manage multiple sustaining engineering and fixture development projects, encompassing both hardware and software, from initiation through closure.

• Leads risk assessment for technical and project related issues and developing mitigation plans to ensure appropriate mitigations are in place, to ensure schedule and costs are maintained.

• Develop and maintain detailed project plans, timelines, budgets, and resource allocations. Tracks and manages project budgets, metrics, and resource utilization

• Facilitate regular project meetings, track progress, and manage risks and issues.

• Report out progress, issues and status at regular review meetings.

• Ensure projects meet regulatory, quality, and business requirements.

• Manages multiple concurrent projects and ensures timely progress reporting and escalation of issues impacting deliver
Cross-Functional Leadership

• Collaborate with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams.

• Coordinate with external vendors and contract manufacturers as needed.

• Serve as the primary point of contact for project status and communication.
Sustaining Engineering

• Manage engineering change orders, product updates, and obsolescence strategies.

• Support root cause analysis and corrective/preventive actions (CAPA).

• Drive cost reduction, reliability improvements, and design optimizations.
Manufacturing Fixture Development

• Oversee the design, validation, and implementation of manufacturing fixtures and tooling.

• Ensure fixtures meet any ergonomic, safety, and regulatory standards.

• Support process validation (IQ/OQ/PQ) and documentation.

Skills & Competencies

• Strong knowledge of FDA 21 CFR Parts 820, design controls, ISO 13485, and GMP.

• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).

• Excellent communication, leadership, and organizational skills.

• PMP certification or equivalent is a plus.

• Familiarity with CAD tools and fixture design principles is a plus.

Education & Experience

• Bachelor’s degree in Engineering, Biomedical Engineering, Computer Science, Mechanical Engineering, or related field.

• 3+ years of project management experience in the medical device industry.

• Experience with sustaining engineering and manufacturing support is a plus

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.