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Summary
Ensures that overall project goals and budget requirements are met in a timely manner. Responsible for operations project implementation, that ensures successful transition with little or no impact on the customer.
Project Managers provide business and technical leadership for small to medium projects for new products or services. Involves managing the project and leading the project team through the implementation process at the Hayward facility.
They will lead cross-functional teams and act as the focal point for communication to leadership. This person will interact with internal stakeholders. Project Managers will make launch date commitments and manage stakeholder expectations with regards to Client deliverables during development.
The Project Manager is accountable for overall project performance and integration of project activities.

Essential Duties and Responsibilities
1. Position is the management of Device projects in a manufacturing environment. Develop and manufacture Biosurgery class III medical devices.
2. Accountable for the overall project design and implementation of the completed program.
3. Responsible for project oversight in order to maximize the effective use of project resources.
4. Assesses project issues and develops resolutions to meet productivity, quality, and client satisfaction goals and objectives.
5. Develop procedure and training material in order to provide cleat and consistent policies on how the new program is managed.
6. Coordinate and conduct training in a timely manner for all departments affected by the new program.
7. Manage directly or through a matrix environment project analysts supporting the project.

Qualifications
1. Must be versed in Project Management tools and must possess knowledge of related disciplines and understand resource management and scheduling.
2. Device development team, manufacturing, product development experience a plus.
3. Must have knowledge of FDA guidelines, EU MDR guidelines, GXP regulations and quality management systems for both medical devices and biologics manufacturing; ISO 13485, 1CFR Parts, 11, 210, 211 and 820 (at minimum).
4. Experience with Quality Systems and processes such as Good Documentation Practices (GDP), Management Review, Change Control, etc.
5. Understanding of manufacturing operations and Good Manufacturing Practices (GMPs).
6. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experiences, as well as, project managements tools.
7. Ability to design and implement projects/studies outside area of expertise.
8. Must demonstrate strategic leadership and display ability to communicate effectively using a wide variety of skills and vehicles.

Demonstrated analytical, problem solving, and leadership skills required. Must have excellent oral and written communication skills. Ability to communicate in a clear and concise manner with all levels of an organization.

Education and/or Experience 1. Bachelor's Degree or equivalent required. In addition a minimum of two years product development or manufacturing experience required and zero to three years previous project management experience required.
PMP (Project Management Professional) Certification and/or CPIP (Certified Pharmaceutical Industry Professional) is preferred.

Physical Demands
Regular attendance is necessary to perform the essential functions of the job.
Light work, frequent lifting up to 10 lbs; frequent standing/walking.
Working Environment
Minimal to moderate travel required.
Normal office working conditions: computer, phone, files, fax, copier.