Description

Lead project execution and design control activities in a regulated medical device environment. Own the lifecycle from initiation through change notifications and design transfer.

Responsibilities

• Develop and manage project plans using MS Project and OnePlan, driving execution from initiation through change control.
• Oversee design control documentation including Design Inputs, Traceability Matrices, Specifications, Verification Plans, and FMEA.
• Coordinate engineering changes for Cost to Win, Line Extension, Quality Improvement, and Supplier Validation.
• Manage transactions in PLM tools (MasterControl, PEGA) and support Design History File audits.
• Prepare project status reports, risk assessments, and obsolescence reports for client portfolio managers.

Required Skills

• Bachelor’s degree in Mechanical Engineering.
• 10+ years of experience in Project Management, preferably in Medical Devices or regulated industries.
• Proficiency in MS Project (MPP), MS Office Suite, and PLM tools like MasterControl and PEGA.
• Experience with OnePlan for project planning and execution.
• Knowledge of SolidWorks and AutoCAD for engineering context.
• Familiarity with Minitab for statistical analysis and process validation.
• Strong understanding of ISO 13485 and 21 CFR Part 820.
• Excellent communication and stakeholder management skills for cross-functional coordination.

Preferred Skills

• Basic R&D and Engineering knowledge (Mechanical/Electrical).
• Experience with Design Verification Testing and Process Validation (IQ/OQ/PQ).

Key Skills

Education

Bachelor's degree