What are the responsibilities and job description for the Manufacturing Project Engineer (Medical Devices) - On W2 position at Kyyba Inc?
We are seeking an experienced and results-oriented Project Engineer to independently lead sustaining engineering, supplier change, and continuous improvement projects while supporting larger strategic initiatives across the Electrophysiology organization.
This role is responsible for planning, coordinating, and executing projects in accordance with Client's project management methodologies and quality system requirements. The Project Engineer partners with cross-functional teams to manage project scope, schedules, risks, deliverables, and stakeholder communications to ensure successful project execution and achievement of business objectives.
The successful candidate will independently drive project activities from initiation through implementation, provide leadership within matrixed project teams, and contribute to project governance, reporting, and communication activities. Success in this role requires strong organizational, leadership, and communication skills, along with the ability to influence cross-functional stakeholders and proactively resolve project challenges.
Job Description
- Lead the planning, execution, and implementation of sustaining engineering, supplier change, design change, and continuous improvement projects in accordance with Client project management methodologies.
- Independently manage project scope, schedules, milestones, risks, action items, and deliverables to ensure projects are completed on time and aligned with business objectives.
- Lead cross-functional project teams including R&D, Operations, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Packaging, Labeling, Technical Publications, and other functional stakeholders.
- Facilitate project team meetings, drive accountability for project deliverables, and ensure alignment across functional groups.
- Identify project risks, issues, and dependencies; develop mitigation strategies and coordinate resolution activities.
- Partner with functional team members and managers to support project resource planning, priority setting, and issue resolution.
- Develop and maintain project plans, schedules, risk registers, action-item logs, and project documentation.
- Communicate project status, risks, key decisions, and recommendations to project stakeholders and management.
- Support project governance activities through development of project metrics, dashboards, status reports, and leadership communications.
- Lead assigned workstreams within larger strategic initiatives while ensuring alignment with overall project objectives and timelines.
- Execute project support activities including ownership of Change Orders (COs), procurement coordination, project reporting, and maintenance of project tracking systems.
- Utilize Windchill, SAP, Planview, Ariba, and other business systems to support project execution, reporting, portfolio visibility, and procurement activities.
- Partner with suppliers and external stakeholders to support project implementation activities and issue resolution.
- Ensure project activities comply with FDA regulations, applicable quality system requirements, Company policies, and Business Unit operating procedures.
Required Qualifications
- Bachelor's degree in engineering or related field
- Minimum 5 years of medical device experience in R&D, Manufacturing and/or Quality Engineering
- Excellent verbal and written communication skills, with the ability to communicate to all levels of the organization as well as Client suppliers and consultants
- Experience collaborating with cross-functional team members in a geographically diverse, matrixed organization
- Demonstrated experience leading cross-functional projects or project workstreams
- Ability to initiate, prioritize, and coordinate multiple tasks simultaneously
- Proficient in MS Word, Excel, PowerPoint, and Project
- Ability to travel up to 10% of the time domestically and/or internationally
Preferred Qualifications
- Master's degree in a technical or business field
- PMP, CAPM, or other project management certification
- Familiarity with Windchill (Product Lifecycle Management System), SAP (Enterprise Resource Management software), Planview (Project and Portfolio Management software), and Ariba (Purchasing system)
- Experience leading sustaining engineering, supplier change, or operations projects within a regulated industry
- Experience supporting product lifecycle management activities, including Change Orders (COs), documentation updates, supplier changes, and design transfer activities
- Experience developing project metrics, dashboards, and leadership communications
- Experience working in a regulated industry such as medical devices, pharmaceuticals, aerospace, or manufacturing
- Knowledge of continuous improvement methodologies such as Lean, Six Sigma, or Kaizen
Salary : $42 - $46