SeniorProgram Manager-EU/MDR Compliance
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 (GSC) 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 across all product lines within GSC. Review and approve deliverables per the Design Controls Process from inception through product end of life for product lines.
- Define and manage the Product Life cycle
- 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 the technical aspects of the products from inception through end of life
- Responsible for coordinating cross-functional and cross-business unit tasks and sub-projects having serious business level impact, such as:
- Assessing product designs for impact of changes to standards across all product lines
- Project Management of large-scale regulatory implementation projects across product lines such as MDR, RoHS/REACH, etc.
- Lead the Product Design Teams according to relevant Quality Management Systemprocessesand regulatory requirements
- Be the central point for handling issues and taking decisions regarding the product designs throughout the life cycle
- Ensure the products comply with all relevant QMS elements and regulatory requirements throughout their life cycle
You are a part of:
You will report directly to the Manager of Program Management, General and Specialty Care (GSC) Business Unit. GSC is a dynamic and growing part of Philips Monitoring and Analytics & Therapeutic Care (MA&TC) business group.
To succeed in this role, you should have the following skills and experience:
- BS Engineering, or equivalent applicable science degree, required. Advanced degree a plus.
- 7+ years’ minimum experience in medical device, automotive or aerospace industries in design and/or project management. 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.
- Experience with FDA and MDD/MDR Quality Management System requirements, including Design Controls, Purchasing Controls, and Safety Risk Assessment or equivalent.
- Demonstrated experience in managing/improving product performance and product quality (defect rates, etc.) improvements. Experience with FMEA, Lean, DfX, and Reliability a plus.
- Project management skills including 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.