Primary Function of Position:
We are seeking a Senior Project Coordinator to support the Program Management team focused on new product development. The Senior Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Control and Project Management processes with a strong focus on collaboration with cross-functional groups. Need to be proactive a strong communicator key influencer relationship builder detail-oriented and have investigative skills. This is the position for you if you love to help teams thrive and exceed expectations!
Job Requirements:
- Work with Project Managers defining and tracking Project Plans Risk Management Plans work breakdown structure project budget and task definitions
- Monitor and report project status for project milestones documentation and deliverables
- Review projects for possible interference/variances to schedule and/or specifications: proactively organize efforts to alleviate bottlenecks and speed execution.
- Coordinate and follow up on activities of team leader / program manager; represent the team and assigned projects where necessary
- Support/Lead team meetings including taking minutes and tracking action items.
- Initiate develop and implement departmental process related improvements
- Closely track Verification and Validation protocols and reports for Regulatory submissions
- Work all across New Product Development on milestone activities including ECO submissions reviews and closure
- Coordinate design reviews and phase gate reviews Assembling presentations Checklists action items etc.
- Solid understanding of Quality Systems or Design Controls for Medical Devices
- Setup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs
- Maintain business review packages and business records for projects assigned
- Strong collaboration and direct participation with Regulatory during final preparations for submissions
- Track Issues coordinate last minute changes
- Liaison with Document Control and follow-up with approvers of change orders to ensure timely review and approval
- Manage lab resources (hardware software instruments and accessories) and monitor allocations based on the needs and schedule of various competing projects.
- Support historical investigations including audit requests CAPA and process improvement projects
- CAPA tracking/closure support
Qualifications :
Skills Experience Education & Training:
- Bachelors Degree required. Masters degree preferred.
- 5 years of directly related experience desired medical devices experience strongly preferred
- Additional specialized training in a discipline such as computers and/or planning and scheduling
- Good organizational and investigative skills
- Proactive problem solver
- Excellent verbal and written communication skills
- Ability to switch between many different projects quickly
- Passion for rapidly executing projects creating robust and reliable products
- Familiar with waterfall SCRUM and hybrid project management techniques
- Should be highly proficient in Word Excel and PowerPoint
- Active user of Microsoft Project or other project planning and tracking tools
- Proficiency in Oracle/Agile and SAP a plus
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminación y acoso independientemente de su raza sexo condición de embarazo orientación sexual identidad de género origen nacional color edad religión condición de veterano protegido o de discapacidad información genética o cualquier otra condición protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Full-time
Primary Function of Position:We are seeking a Senior Project Coordinator to support the Program Management team focused on new product development. The Senior Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Cont...
Primary Function of Position:
We are seeking a Senior Project Coordinator to support the Program Management team focused on new product development. The Senior Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Control and Project Management processes with a strong focus on collaboration with cross-functional groups. Need to be proactive a strong communicator key influencer relationship builder detail-oriented and have investigative skills. This is the position for you if you love to help teams thrive and exceed expectations!
Job Requirements:
- Work with Project Managers defining and tracking Project Plans Risk Management Plans work breakdown structure project budget and task definitions
- Monitor and report project status for project milestones documentation and deliverables
- Review projects for possible interference/variances to schedule and/or specifications: proactively organize efforts to alleviate bottlenecks and speed execution.
- Coordinate and follow up on activities of team leader / program manager; represent the team and assigned projects where necessary
- Support/Lead team meetings including taking minutes and tracking action items.
- Initiate develop and implement departmental process related improvements
- Closely track Verification and Validation protocols and reports for Regulatory submissions
- Work all across New Product Development on milestone activities including ECO submissions reviews and closure
- Coordinate design reviews and phase gate reviews Assembling presentations Checklists action items etc.
- Solid understanding of Quality Systems or Design Controls for Medical Devices
- Setup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs
- Maintain business review packages and business records for projects assigned
- Strong collaboration and direct participation with Regulatory during final preparations for submissions
- Track Issues coordinate last minute changes
- Liaison with Document Control and follow-up with approvers of change orders to ensure timely review and approval
- Manage lab resources (hardware software instruments and accessories) and monitor allocations based on the needs and schedule of various competing projects.
- Support historical investigations including audit requests CAPA and process improvement projects
- CAPA tracking/closure support
Qualifications :
Skills Experience Education & Training:
- Bachelors Degree required. Masters degree preferred.
- 5 years of directly related experience desired medical devices experience strongly preferred
- Additional specialized training in a discipline such as computers and/or planning and scheduling
- Good organizational and investigative skills
- Proactive problem solver
- Excellent verbal and written communication skills
- Ability to switch between many different projects quickly
- Passion for rapidly executing projects creating robust and reliable products
- Familiar with waterfall SCRUM and hybrid project management techniques
- Should be highly proficient in Word Excel and PowerPoint
- Active user of Microsoft Project or other project planning and tracking tools
- Proficiency in Oracle/Agile and SAP a plus
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminación y acoso independientemente de su raza sexo condición de embarazo orientación sexual identidad de género origen nacional color edad religión condición de veterano protegido o de discapacidad información genética o cualquier otra condición protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Full-time
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