Project Manager, Quality Engineering, Regulatory Compliance Specialist

Job Title:

Project Manager

Job Description

The Project Manager leads technical sustaining engineering projects from concept to completion, overseeing planning, scheduling, budget management, and resource allocation for change controls. This role collaborates closely with quality, regulatory, and design teams to support manufacturing change orders, component replacements, and coordination with external vendors. The Project Manager ensures that all project requirements comply with process qualification standards, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), within a medical device or pharmaceutical environment.

Responsibilities

* Lead technical sustaining engineering projects from initial concept through completion, ensuring delivery on time, within scope, and within budget.

* Plan and manage project schedules, timelines, and milestones using project management tools such as Microsoft Project and Excel.

* Develop, track, and control project budgets, ensuring effective allocation and utilization of resources.

* Coordinate and manage change controls, including manufacturing change orders and component replacement activities.

* Work cross-functionally with quality, regulatory, and design teams to support sustaining engineering initiatives and product improvements.

* Collaborate with external vendors to align project requirements, timelines, and deliverables.

* Ensure that all project activities meet process qualification requirements, including IQ, OQ, and PQ.

* Support sustaining engineering activities such as design reviews, quality investigations, and regulatory interactions.

* Contribute to process development and product development engineering within the product development life cycle.

* Document project plans, decisions, risks, and outcomes in accordance with engineering and regulatory standards.

* Monitor and report project status to stakeholders, proactively addressing risks, issues, and changes.

* Ensure that all work complies with medical device and pharmaceutical industry standards and internal procedures.

Essential Skills

* Bachelor's degree in engineering, such as biomedical or mechanical engineering.

* 6+ years of project management experience.

* 6+ years of experience using project management tools, including Microsoft Project and Excel.

* 3+ years of experience managing project schedules, timelines, and budgets.

* 3+ years of sustaining engineering experience, including participation in design reviews, quality support, and regulatory interactions.

* 3+ years of experience working with medical devices.

* Proven experience in project coordination and project engineering within technical or engineering environments.

* Knowledge of process qualification activities, including IQ, OQ, and PQ.

* Experience working with change orders and manufacturing change controls.

* Experience in mechanical or product development engineering.

* Familiarity with medical device or pharmaceutical product development life cycles.

* Ability to work effectively with cross-functional teams, including quality, regulatory, and design.

Additional

Skills & Qualifications

* Experience in sustaining engineering within medical device or pharmaceutical industries.

* Exposure to process development and verification activities.

* Mechanical engineering or biomedical engineering experience with practical design or product development experience.

* Experience interacting with external vendors and coordinating external project activities.

* Strong analytical and organizational skills, with attention to detail in documentation and compliance.

* Ability to manage multiple projects or work streams concurrently in a structured manner.

* Comfort working within regulated environments with quality and regulatory oversight.

Work Environment

This is a long-term project-based position with no guarantee of transition to a full-time permanent role after the contract period. The Project Manager works in a technical, engineering-focused environment within the medical device or pharmaceutical sector, collaborating closely with quality, regulatory, and design teams as well as external vendors. The role relies heavily on project management tools such as Microsoft Project and Excel to manage schedules, timelines, and budgets, and operates within a structured, process-driven setting that emphasizes compliance with engineering, quality, and regulatory standards

Job Type & Location

This is a Contract position based out of Madison, WI.

Pay and Benefits

The pay range for this position is $45.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

* Medical, dental & vision

* Critical Illness, Accident, and Hospital

* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions…