Director, Project Management, Medical Devices & Diagnostics

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Director, PMO will report directly into the COO, will serve as a member of the Executive Management team and will be responsible for leading and managing the project management function for the Autoimmunity division. This individual has oversight of product related projects within the business. Ensures effective project management methodology is deployed and used throughout the business for product development and life-cycle management (on-market). Monitors project performance and ensures that all key projects are being executed to Scope, on time and within budget.Identifies both trends in project management practices and risks in specific projects that need to be resolved. Coordinates with the functional managers and executives to ensure resource are allocated in the best manner to optimized business and project results. Collaborates with other Werfen entities on best practices of project management. Works to continiuously increase the maturity level of the PMO towards a strategic project management office (sPMO). Ensures all work is carried out in accordance with Autoimmunity's Quality Management System as well as all of administrative and regulatory requirements.

Participates in business strategic planning, representing current and planned projects needed to implement the business strategy. Provides direct and/or indirect supervision to members of the management team and/or members of the PMO. Position requires strong, cross-functional leadership skills in a highly technical medical device product development environment.

Key Accountabilities

• Technical and Program Leadership: Provide general oversight and leadership to all product development projects. Responsible to assign project managers to all product development projets and other strategic project as defined by the senior management team.
• Project Management Process: Establishes, defines and maintains the project management system and processes. Provides direction to the Project Sponsor with respect to the project scope, objectives, deliverables and measurements for the product development project management methodology. Works with project managers to define project team composition, meeting structure and caidance. Conduct regular reviews of the program / project portfolio of all product development projects to ensure business objectives will be met. Work with the Project Sponsors to continually improve the product development project management methodology.
• Program Planning, Execution and Control: Periodically review project plans (scope, timeline and budget) and status to ensure the application of best practices for project management and the efficacy of the product development project management methodology. Periodically review the status of the portfolio of development projects and programs with other members of the senior management team.
• Strategy Development: Participates with senior management in mid- to long-term strategy related to new areas of scientific and technological research and development. Originates major new ideas for company projects and programs.
• Risk Management: Oversees project risk management from project planning to completion. This includes but is not limited to baseline risk analysis and mitigation. Periodically review project risk drivers and actions to identify trends. Implement organizational and process changes to reduce overall project risk.
• Design Control: Oversees the creation and maitainance of all elements required for Design Control procedure. This includes management according to our design control procedure using a phase gate approach.
• Business Management: As a member of the business management team, provide plans and status updates concerning product development and life-cycle management projects that support the business. Participate with other senior management team to make the best use of resources among the competing business needs. Ensures that an adequate pool of equipment and resources are available to meet the needs of the projects within the business constraints. Prepares and manages department budgets.
• Communication: Regularly interacts with senior management, customers and regulatory agencies concerning program status and strategic planning.
• Supervision and Employee Performance: Leads and manages the PMO team, including people managers and individual contributors. Responsible for hiring and developing a high performance team. Role models Werfen Values and ensures compliance with company policies.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Research & development teams (both)
• Clinical Software team
• Quality & Regulatory teams
• Manufacturing teams
• Other Autoimmunity and Werfen departments and staff

Minimum Knowledge & Experience for the position:

• BS Degree, MS/MBA preferred, in a technical or management discipline
• PMP certification is preferred additional course work in accounting, business economics, resource management and project management is desired.
• Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing in IVD insustry
• Fifteen years product development experience, including eight years in successful technical leadership, project coordination, or project management are required.
• Experience in the development and release of at least one successful product launch of a medical device product is required.

Skills & Capabilities:

• Business Acumen; Technical Skills; Process Management;
• Strong organization and planning skills
• Strong oral and written communication skills
• Stakeholder management and Leading in a matrix

Travel requirements:

• <10%

Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.

The salary range for this position is currently $150,000- $225,000. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com