Job Description Summary

Position Overview:

This position is responsible for the project management of engineering programs through a methodical approach of planning, executing and controlling projects from start to finish. The PM demonstrates program ownership and guides teams through project execution process while translating strategic objectives to an execution level. Helps ensure consistent practices throughout all phases of the project life cycle and across project functional teams. Use professional project management concepts and frameworks in accordance with company objectives to solve complex problems in a creative and effective way. Exercise a balance of independent judgment and group organization in developing methods, techniques, and evaluation criteria for obtaining results.

Responsibilities:
• Effectively lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements.
• Maintain and monitor project budgets, directing the efficient use of resources to effectively complete projects.
• Lead project-related activities of project team members, providing guidance on conformance to established design control procedures.
• Prepare project summary reports, develops project plans, identifies risk and communicates mitigation activities.
• Prepare and deliver project status presentations to Management regularly.
• Lead and/or participate in all phases of development starting with concept through design transfer, including VOC, design input development and obtain required approvals for design input and design output required documentation working with Commercial and RA/DA/QA.
• Participate in and/or oversee all design and process validation activities required for assigned projects.
• Provide support and guidance to Clinical Affairs team for physician evaluations, animal studies, and clinical trials required to effectively assess the design of a new product.
• Constantly work to improve the internal systems for design control in order to improve the time-to-market cycle for new products.
• Adhere to all regulatory agency standards, company quality standards and corporate policies.
• Must be able to travel domestically and internationally as business needs demand.
• Perform other duties as required.

Education and Experience

Minimum Requirements:
• Bachelor's Degree
• At least 10 years of overall work experience in a technical discipline and 5 years of demonstrated experience in a program management role

Preferred Skills and Competencies:
• Prior experience in a Medical device and/or engineering organization preferred
• Project management certification preferred
• Experience in Agile and Scrum methodology
• Knowledgeable of the US and International Medical Device and Drug Delivery Regulations
• Knowledgeable of Software development and Mobile Application development strongly preferred
• Demonstrated proficiency in project management
• Demonstrated experience leading a project in a cross-functional environment
• Demonstrated experience in managing a program budget
• Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment
• Strong organizational and communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Proficient in the following computer software applications: MS Office products, Outlook, Word, Excel, PowerPoint, and Project.
• Helpful to have working knowledge or familiarity with ProSolution’s, ProChain Enterprise PM tool kit, DOORS and Sharepoint
• Prior experience working in a regulated environment

Physical Requirements:

• none

The position can be remote, hybrid or in-person, Travel is estimated at 25% but will flex depending on business needs