Senior Project Manager-Medical Device

Description : ABOUT US

ABOUT US

Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life.

Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide.

Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA.

Cerapedics is headquartered in Westminster, CO.

OVERVIEW

Are you looking for an innovative company that will inspire you and support your career? If so, Cerapedics is hiring professionals like you.

Join us as a Senior Project Manager in our Westminster office.

JOB SUMMARY :

At Cerapedics, you will contribute to our mission to better patient's lives through meaningful work and have ample opportunities for career development.

As a Senior Project Manager working on the Global PMO team, you will be empowered to drive critical business initiatives and help us successfully execute infrastructure, development and commercial projects.

A typical day will include :

Managing matrixed resources to ensure projects meet their defined objects and milestones. Driving various initiatives and projects to support continued business growth.

Advising teams on necessary strategic and tactical elements to ensure successful project execution.

• Leading cross functional teams to deliver labeling and manufacturing expansion programs through successful launch and commercialization.
• Working with project teams to deliver necessary updates and communications to senior leadership.

This position will report to the Senior Manager of Global Program Management and will help drive key projects while concurrently contributing to the establishment and maintenance of governance and portfolio management processes.

This role will allow for hybrid work, but will require majority of work onsite.

POSITION OBJECTIVES :

• Organize and lead distributed, cross functional teams to meet successful completion of projects and Cerapedics business objectives.
• Manage projects of varying size and complexity and tailor project management tools according to the scope of the project.
• Support a diverse array of projects focused on manufacturing expansion and operations initiatives.

SPECIFIC FUNCTIONS AND RESPONSIBILITIES :

• Collaborate with stakeholders to define, manage, and own project scope and project plan.
• Partner with project team to develop project schedule, budget, and resource needs for assigned projects.
• Create project risk management plans and develop risk response plan for key project risks to ensure successful project execution.
• Ensure alignment between core teams and stakeholders through timely and effective stakeholder communication on project progress and potential escalations.
• Develop appropriate metrics and tools for tracking project status to ensure accountability and monitor project success.
• Help develop and deploy project management tools and templates for consistent execution.
• Work with the project core team to maintain and develop Design and Project History Files.
• Monitor and ensure compliance with applicable company policies and procedures.

EDUCATION OR FORMAL TRAINING REQUIRED :

• Bachelor's degree in Engineering or Scientific discipline or an equivalent combination of education and work experience.
• Advance degree or MBA strongly preferred.
• 6+ years of experience in project leadership with progressively increasing responsibility or complexity.
• 4+ leading projects in a medical device, biomedical, pharmaceutical, or high technology industry.

Requirements :

QUALIFICATIONS REQUIRED :

• Excellent communication, interpersonal and listening skills. Ability to communicate across various levels of the organization and deliver tailored messaging based on audience.
• Ability to lead diverse and complex projects and programs, and coordinate multiple teams to execute concurrent and interdependent projects.
• Experience leading medical device or pharmaceutical manufacturing / operations expansion projects.
• Experience managing validation and qualification initiatives related to capacity expansion.
• Exposure to a wide range of project management tools and techniques.
• Ability to engage and influence cross-functional colleagues without direct authority.
• Strong organizational and planning skills and ability to hold others accountable.
• Willingness to step up and take on additional responsibility when appropriate.
• Proficiency with one or more project management scheduling tools (e.g. MS Project)
• Proficiency with MS Office

PREFERRED :

• PMP certification
• Lean Leader / Six Sigma Certification
• Experience with Resource Management tools
• Strong Knowledge of medical device regulations. Well versed in R&D, product development and clinical / regulatory processes

Benefits (including, but not limited to) :

Medical, dental, and vision insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off, tuition reimbursement, and pet insurance.

Base salary- $120k-$135k plus target bonus.

EEO STATEMENT : Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

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