Sustaining Engineering Project Manager

Covington, OH - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Role: Sustaining Engineering Project Manager
Location: Covington GA

Job Description:

The Project Manager will lead and manage Sustaining Engineering projects for AcuteCare HomeCare and DryDoc product lines. This role involves planning coordinating and executing engineering changes compliance activities and product lifecycle management in alignment with quality systems. The Project Manager will work closely with cross-functional teams (R&D Quality Regulatory Manufacturing) to ensure timely delivery of project objectives.

Key Responsibilities:

Develop and manage project plans using MS Project / OnePlan.
Drive project execution from initiation through change notifications (Project Charter ECR).
Manage change control and design planning through CCP/DDP/PEGA.
Coordinate engineering changes for Cost to Win Line Extension Quality Improvement Labeling & Packaging Supplier Validation Regulatory Compliance.
Support design transfer activities and Design History File audits.
Oversee creation and updates of design control documents (Design Inputs Traceability Matrix Specifications Verification Plans Protocols & Reports FMEA).
Gather requirements and responses from cross-functional teams.
Coordinate with teams for Design Verification Testing and Process Validation (IQ/OQ/PQ).
Manage transactions in PLM tools (MasterControl PEGA).
Prepare project status reports risk assessments and obsolescence reports.
Conducting periodic Review with core team members and update the project status update to Client portfolio manager.

Required Skills

Strong Project Management skills with experience in regulated industries.
Basic R&D and Engineering knowledge (Mechanical/Electrical).
Proficiency in MS Project (MPP) and MS Office Suite.
Familiarity with tools like SolidWorks AutoCAD Minitab (statistical analysis).
Excellent communication and stakeholder management skills.
Cross-functional coordination and collaboration skills.
Qualifications
Bachelors degree in mechanical engineering.
10 years of experience in Project Management preferably in Medical Devices or regulated industry.
Knowledge of ISO 13485 / QSR 21 CFR Part 820 is an advantage.

Tools & Systems: MS Project MasterControl PEGA OnePlan SolidWorks AutoCAD Minitab

Role: Sustaining Engineering Project Manager Location: Covington GA Job Description: The Project Manager will lead and manage Sustaining Engineering projects for AcuteCare HomeCare and DryDoc product lines. This role involves planning coordinating and executing engineering changes compliance activit...

Role: Sustaining Engineering Project Manager
Location: Covington GA

Job Description:

Key Responsibilities:

Develop and manage project plans using MS Project / OnePlan.
Drive project execution from initiation through change notifications (Project Charter ECR).
Manage change control and design planning through CCP/DDP/PEGA.
Coordinate engineering changes for Cost to Win Line Extension Quality Improvement Labeling & Packaging Supplier Validation Regulatory Compliance.
Support design transfer activities and Design History File audits.
Oversee creation and updates of design control documents (Design Inputs Traceability Matrix Specifications Verification Plans Protocols & Reports FMEA).
Gather requirements and responses from cross-functional teams.
Coordinate with teams for Design Verification Testing and Process Validation (IQ/OQ/PQ).
Manage transactions in PLM tools (MasterControl PEGA).
Prepare project status reports risk assessments and obsolescence reports.
Conducting periodic Review with core team members and update the project status update to Client portfolio manager.

Required Skills

Strong Project Management skills with experience in regulated industries.
Basic R&D and Engineering knowledge (Mechanical/Electrical).
Proficiency in MS Project (MPP) and MS Office Suite.
Familiarity with tools like SolidWorks AutoCAD Minitab (statistical analysis).
Excellent communication and stakeholder management skills.
Cross-functional coordination and collaboration skills.
Qualifications
Bachelors degree in mechanical engineering.
10 years of experience in Project Management preferably in Medical Devices or regulated industry.
Knowledge of ISO 13485 / QSR 21 CFR Part 820 is an advantage.

Tools & Systems: MS Project MasterControl PEGA OnePlan SolidWorks AutoCAD Minitab