Project Manager

Job Title: Project Manager Sustaining Engineering & Fixture Development

Location: Onsite Madison, WI

Job Type: Full-Time / Contract

Industry: Medical Devices / Engineering / Manufacturing





Job Summary:



We are seeking a skilled and detail-oriented Project Manager with a background in engineering to lead and manage multiple sustaining engineering and fixture development projects within a regulated medical device environment. This role will be based onsite in Madison, WI and will involve collaboration across multiple departments including Product Development, Quality, Regulatory, and Manufacturing.





Key Responsibilities:



Project Management:

• Lead and execute sustaining engineering and fixture development projects, including both hardware and software components, from initiation to completion.
• Develop and maintain project plans, budgets, timelines, and resource allocations.
• Facilitate project meetings, track milestones, manage risks/issues, and report progress to stakeholders.
• Lead risk assessments and create mitigation strategies to minimize project delays and cost overruns.
• Ensure all project deliverables meet regulatory, quality, and business requirements.

Cross-Functional Leadership:

• Collaborate with cross-functional teams including Product Development, Quality, Regulatory, Supply Chain, and Manufacturing.
• Interface with external vendors and contract manufacturers as necessary.
• Act as the primary point of contact for project communications and updates.

Sustaining Engineering:

• Manage engineering change orders (ECOs), product updates, and part obsolescence strategies.
• Support root cause investigations and CAPA (Corrective and Preventive Actions).
• Lead initiatives for cost reduction, design optimization, and improved product reliability.

Fixture Development:

• Oversee design, validation, and implementation of manufacturing fixtures and tooling.
• Ensure fixtures comply with ergonomic, safety, and regulatory standards.
• Support equipment/process validation including IQ/OQ/PQ and associated documentation.

Qualifications:



Education:

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

Experience:

• Minimum 3 years of project management experience in the medical device industry.
• Experience with sustaining engineering and manufacturing environments preferred.

Skills & Competencies:

• Strong knowledge of FDA 21 CFR Part 820, design controls, ISO 13485, and GMP regulations.
• Proficiency in project management tools such as Microsoft Project, Smartsheet, or Jira.
• Excellent written and verbal communication, leadership, and interpersonal skills.
• PMP certification or equivalent is a plus.
• Familiarity with CAD tools and fixture/tooling design is desirable.