Description

Manage engineering projects through the entire lifecycle in a regulated environment.

Manage engineering projects through the entire lifecycle in a regulated environment.

Responsibilities

• Develop and manage project plans using MS Project or OnePlan.
• Drive project execution from initiation through change notifications including Project Charter and ECR.
• Manage change control and design planning using CCP, DDP, or PEGA.
• Coordinate engineering changes across Cost to Win, Line Extension, Quality Improvement, and Regulatory Compliance.
• Oversee the creation and updates of design control documents, including Traceability Matrix and Verification Plans.

Required Skills

• 10+ years of experience in Project Management within Medical Devices or a regulated industry.
• Bachelor's degree in mechanical engineering.
• Strong project management skills within regulated industries.
• Proficiency in MS Project (MPP) and MS Office Suite.
• Experience managing transactions in PLM tools like MasterControl and PEGA.
• Familiarity with mechanical/electrical R&D and Engineering knowledge.
• Proficiency with tools including SolidWorks, AutoCAD, and MiniTab.
• Excellent cross-functional coordination and stakeholder management abilities.

Key Skills

Education

Bachelor's degree