USA - Engineering Project Manager III- Kronos - Varite, Inc
Skaneateles, NY 13153
About the Job
JOB SUMMARY:
Program Manager to lead the activities to ensure compliant EU MDR Technical File submissions of on market Front Line Care (FLC) Products. The Program will address multiple projects/submissions across the Front Line Care Portfolio. Responsible for managing overall execution and communication between the individual Project teams, key stakeholders, and leadership.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Coordinates work performed within multiple functions including R&D, Packaging, Operations, Regulatory and Quality by facilitating project scope definition, managing budget, and monitoring risk on a program level scale.
• Supports team by assessing and managing resource allocation, progress tracking and facilitating budget and schedule changes through the change control process.
• Ensures adherence to quality standards and reviews project deliverables with stakeholders.
• Manages vendor partners, provides guidance to project team, provides senior leadership with status updates.
•Strong partner with Regulatory leadership and Certificate Strategy team to ensure successful certifications for all in scope products.
• Responsible for managing team of contract project managers who lead the individual projects under the program.
UNIQUE QUALIFICATIONS AND SKILLS:
• Good communication and organizational skills required.
• Must have previous experience as a project manager in medical device field for a minimum of 5 yrs.
• Experience with EU regulatory systems and requirements as well as technical knowledge of operations execution
• PMP Certification preferred.
• Excellent analytical and pragmatic problem-solving skills.
• Ability to provide strategic advice as well as operational solutions
• Strong interpersonal skills with the ability to influence and communicate with individuals at all levels in an organization
• Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
• Track record in providing high degree of reliance, accountability, and value-added consultation/support to business managers and other support functions
EDUCATION AND EXPERIENCE:
Bachelor's Degree or local equivalent of same; generally, 8-11 years of experience (minimum 5).
Program Manager to lead the activities to ensure compliant EU MDR Technical File submissions of on market Front Line Care (FLC) Products. The Program will address multiple projects/submissions across the Front Line Care Portfolio. Responsible for managing overall execution and communication between the individual Project teams, key stakeholders, and leadership.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Coordinates work performed within multiple functions including R&D, Packaging, Operations, Regulatory and Quality by facilitating project scope definition, managing budget, and monitoring risk on a program level scale.
• Supports team by assessing and managing resource allocation, progress tracking and facilitating budget and schedule changes through the change control process.
• Ensures adherence to quality standards and reviews project deliverables with stakeholders.
• Manages vendor partners, provides guidance to project team, provides senior leadership with status updates.
•Strong partner with Regulatory leadership and Certificate Strategy team to ensure successful certifications for all in scope products.
• Responsible for managing team of contract project managers who lead the individual projects under the program.
UNIQUE QUALIFICATIONS AND SKILLS:
• Good communication and organizational skills required.
• Must have previous experience as a project manager in medical device field for a minimum of 5 yrs.
• Experience with EU regulatory systems and requirements as well as technical knowledge of operations execution
• PMP Certification preferred.
• Excellent analytical and pragmatic problem-solving skills.
• Ability to provide strategic advice as well as operational solutions
• Strong interpersonal skills with the ability to influence and communicate with individuals at all levels in an organization
• Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
• Track record in providing high degree of reliance, accountability, and value-added consultation/support to business managers and other support functions
EDUCATION AND EXPERIENCE:
Bachelor's Degree or local equivalent of same; generally, 8-11 years of experience (minimum 5).
Source : Varite, Inc