Marissa Wagner
Philadelphia,Pennsylvania
Summary
Results-driven Project Manager with proven success in leading cross-functional teams and managing complex projects in the medical device industry. Skilled in risk assessment and regulatory compliance, ensuring project timelines and objectives are met effectively.
Overview
5
5
years of professional experience
Work History
Project Manager/Product Owner
Draeger Medical Systems
Telford, Pennsylvania
09.2023 - Current
- Managed Life Cycle Engineering projects for medical electrical devices, addressing obsolete parts and design changes.
- Led creation of MDR-compliant technical files for various medical devices, including neonatal phototherapy systems.
- Developed project timelines and action lists, coordinating with external partners and suppliers to achieve objectives.
- Scheduled cross-functional teams comprising engineering, regulatory, clinical affairs, and quality representatives.
- Facilitated product steering board meetings to evaluate design change requests and communicate product roadmap updates.
- Identified inefficiencies within business unit operations and implemented a project ranking system to enhance throughput.
- Utilized knowledge of team members' communication styles to lead effectively and ensure project completion.
Risk Manager
Draeger Medical Systems
Telford, Pennsylvania
06.2021 - 09.2023
- Identified hazards in electrical, mechanical, and medical devices, addressing biocompatibility, usability, and safety risks.
- Calculated risk probabilities and severities to assess risk acceptability.
- Implemented and verified risk control measures to mitigate device risks effectively.
- Created risk assessments and Health Hazard Analyses for complaints and adverse events to determine necessary field actions.
- Documented annual reviews of standard revisions, device complaints, and ECRI reports to assess changes in device risk.
- Evaluated design change projects for impact on device risk management files.
- Participated in TUV and FDA audits, responding to inquiries without any findings.
Verification Engineer
Draeger Medical Systems
Telford, Pennsylvania
06.2020 - 06.2021
- Developed testing methods and authored test reports for formal verification documentation.
- Created tool files to enhance testing efficiency and accuracy.
- Managed fleet of O-series devices, overseeing software and hardware version tracking.
- Wrote test specifications aligned with technical systems requirements.
- Implemented robust documentation practices to ensure compliance and traceability.
Education
Bachelor of Science - Bioengineering
Lehigh University
Bethlehem, PA05-2020
Skills
- Project management
- Risk assessment
- Regulatory compliance
- Technical documentation
- Cross-functional collaboration
- Product design evaluation
- Hazard analysis
- Change management
- Supplier and partner relations
- Project scheduling
- Progress reporting
Timeline
Project Manager/Product Owner
Draeger Medical Systems
09.2023 - Current
Risk Manager
Draeger Medical Systems
06.2021 - 09.2023
Verification Engineer
Draeger Medical Systems
06.2020 - 06.2021
Bachelor of Science - Bioengineering
Lehigh University
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