Project Manager
Project Manager
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Job Description
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:
- Bachelors 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.
Project Management Skills
Employment Type
Full Time
