| Location | Sunnyvale, CA |
| Salary | $85–$90 Per Hour |
Project Manager (NPI)
Location: Sunnyvale, CA/Hybrid
Duration: 12 months with possible contract to hire/ with possible extension
Description:
Primary Function of Position:
Client designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for an individual to manage labeling projects associated with the development of these products. The role is responsible for the development, planning, and execution of labeling projects that support Client business and operational goals. The successful candidate will interface with cross-functional stakeholders across our organization to act as a central hub of knowledge to manage information, communications, tasks, and timelines. The ideal candidate will have a passion for people, processes, and products, and strive to achieve positive customer experiences within global regulatory requirements.
Roles & Responsibilities:
Develop, communicate, and implement project plans; monitor progress and performance against the plan; resolve problems, mitigate risk, and minimize delays.
Identify scope, develop timeline, and align resources for labeling projects across multiple product lines and geographies to meet objectives.
Drive multiple parallel projects with unique cross-functional team members.
Review labeling updates for labeling content and accuracy to confirm alignment with regulatory requirements.
Estimate costs, resources, and durations required to complete projects and tasks.
Monitor activities, allocate resources, and assign tasks to ensure goals are met.
Liaise with other areas in the organization to secure specialized resources and contributions for projects.
Conduct project meetings and prepare reports to communicate the status of the project within and beyond the project team.
Work through complex scenarios with project staff to assist and/or benchmark strategies to solve problems.
Analyze and evaluate tools and processes; propose and implement accuracy and efficiency improvements.
Foster continuous improvement by initiating and managing process improvement projects employing Six Sigma principles and/or Agile project management methodologies.
Manage highly complex label content for Client diverse products (systems /capital equipment, software, instruments, and accessories).
Interact with external and internal teams to drive labeling-related items and tasks to closure.
Coordinate and support labeling activities with external print vendors, internal manufacturing stakeholders, and New Product Introduction (NPI) teams.
Skills, Experience, Education, & Training:
Minimum four-year Engineering degree (bachelor s degree or equivalent) preferred; business or related field may be considered commensurate to work experience.
Minimum 5 years professional history working in a medical device industry or equivalent experiences.
Experience working in a structured global business environment with multiple disciplines such as Regulatory, Manufacturing, Quality, Information Technology, and Logistics.
Ability to digest, distribute, and adjust communications to various members and levels of the organization.
Strong ability to communicate, verbally and written to internal and external customers in an organized manner.
Self-starter who can independently thrive in a team environment to prioritize tasks and resolve problems.
Highly organized with strong interpersonal, communication, analytical, and soft skills.
Ability to build strong positive working relationships with radical candor.
Enthusiastic individual with a passion to learn and develop project management and business skills.
Familiar with Portfolio Management, Design Control, Risk Management, and Manufacturing Process Controls.
Awareness of medical device regulatory standards and compliance requirements.
Proficient user of Microsoft 365 or similar productivity tools.
Proficient user of Tableau, Smartsheet, or similar project and data management software.
Familiar with SAP, Agile, or similar enterprise software.
Familiar with international, region-specific labeling requirements preferred.
Familiar with a range of labeling methods preferred, such as thermal-transfer printing, pad printing, laser marking.
Call notes:
Client is looking for a strong Project Manager (5-10 years of experience, mid-level) with a background in the Pharma or MedTech industry.
Key Requirements
Experience in New Product Introduction (NPI) and manufacturing environments within the MedTech or Pharmaceutical industry is highly preferred.
Experience handling large-scale, complex projects is a must.
Must have experience managing product launches across multiple countries/regions, such as the U.S., Canada, and Europe.
Labeling experience is a plus but not mandatory, as the Hiring Manager understands that this skill set can be difficult to find in the region.
PMP certification is preferred if somebody has but not required.
Strong stakeholder management and communication skills are required.
Will be responsible for managing approximately 20-25 projects simultaneously.
Responsibilities include:
Attending project meetings
Gathering and documenting requirements
Coordinating with cross-functional teams
Driving projects through completion and ensuring successful delivery
Must possess a positive attitude, strong organizational skills, and the ability to work effectively in a fast-paced environment.