Project Manager, Production Readiness

Position Overview

Lead project activities and be responsible for project planning and execution of cross-platform projects. Responsible for planning and executing activities for production readiness associated with new products, special projects, (e.g., EU MDR) and market expansions launches. Job duties:
  • Be a subject matter expert of the production readiness process and have a high-level understanding of the end-to-end process from product development phases to product launch.
  • Ensure appropriate Global Supply Chain (GSC) integration into the New Product Introduction process through early collaboration with NPI Manufacturability, R&D, and Marketing. Build relationships with business partners to ensure the alignment of Supply Chain Plan objectives and activities.
  • Drive the internal process to ensure production readiness occur in advance of major product builds for either commercial or clinical purposes.
  • Play an instrumental role as a core team member during design control phases and facilitate the product production readiness aligned with project phase gates.
  • Provide technical expertise and lead the facilitation of production readiness align to company strategy.
  • Coordinate cross-functional communication among the different teams involved in the process.
  • Create tracking tools to visualize the production readiness process and track/analyze the progress on products as assigned.
  • Apply change, risk, and resource management. Identify and mitigate risks to the project and communicate risks to stakeholders.
  • Support portfolio management of the initiatives governed by the Product Review Meeting.
  • Collaborate within supply chain in terms demand/supply planning to deliver the production goals and participate in the S&OP review cycle.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Job Details

Job ID 11873BR

Aliso Viejo, California, USA

Salary Range:

$99,266 - $138,972 (Compensation could be higher based on education, experience and skill sets)

    1. Bachelor’s degree in Engineering, Supply Chain, Accounting, or related field.
    2. Minimum of five (5) years of relevant supply chain or operation work experience.
    3. Strong interpersonal skills for effective relationship management with internal and external business partners/customers.
    4. High attention to detail and ability to spot inaccuracies or discrepancies.
    5. Experience leading cross functional teams without direct line reporting authority.
    6. Thorough understanding of project/program management techniques and methods.
    7. Strong written and verbal communication skills.
    8. Proficient with MS Word, Excel, Outlook, and Teams.
    Desired Qualifications
    1. Advanced degree.
    2. CAPM, PMP Certification.
    3. CPIM Certification.
    4. Experience with project management software or tools.
    5. Knowledge of design control phases for medical devices.
    6. Experience with PLM and ERP systems.