In this role, you have the opportunity to:
Lead cross-functional teams through the entire life cycle of the MR product lines in the General & Specialty Care (G&SC) Business Unit of Philips. This role includes Project management of both new product and released products projects; writing and reviewing Design Controls deliverables for new product designs and released products within the assigned product line.
You are responsible for:
- Determining and managing the Design History File and Device Master Record.
- Review and approve deliverables per the Design Controls Process
- Define and manage the Product Lifecycle
- Manage requirements specifications, product risk files, and Design FMEA
- Project Manage Cross-Functional team activities to achieve initial product releases and ongoing design changes throughout the product lifecycle.
- Plan, execute, and communicate project and design deliverables
- Identify risk and actively follow up on response actions defined
- Responsible for coordinating cross-functional and cross-business unit tasks and subprojects having serious business level impact, such as:
- Assessing product designs for impact of changes to standards
- Project Management of regulatory implementation projects across product lines such as MDR, RoHS/REACH, etc.
- Lead the Product Design Teams according to relevant Quality Management System processes and regulatory requirements
- Be the central point for handling issues and taking decisions regarding the product designs throughout the lifecycle
- Ensure the products comply with all relevant QMS elements and regulatory requirements throughout their lifecycle
To succeed in this role, you should have the following skills and experience:
- Minimum of BS Engineering or equivalent experience in Project Management focused in ISO 13485 Medical Product Development,.
- Minimum 5+ years’ experience in Project Management/Product Development for the medical device, automotive or aerospace industries. Medical device experiencepreferred.
- Experience working in multiple functional disciplines (R&D, Supply Chain, Procurement, Quality, and Regulatory) is preferred.
- Experience with IEC 60601 series of standards and ISO 10993 series of standards preferred.
- Strong problem solving skills including root cause analysis and statistical techniques.
- Demonstrated experience in managing/improving product performance and product quality (defect rates, etc.) improvements.
- Project status/KPI communication, schedule management (including tools such as MS Project) and budgeting is required. PMP certification and/or Six Sigma/Lean Certifications preferred.
- Comfortable working with globally distributed teams of engineers and suppliers.
- Demonstrated leadership skills including conflict resolution, negotiation, and influence management desired.
- Demonstrated skill with MS Office suite, MS Teams/SharePoint, SAP, etc. preferred