Philips - Cambridge, MA

posted about 1 month ago

Full-time - Mid Level
Cambridge, MA
Repair and Maintenance

About the position

The Sr. Program Manager for Product & Process Development and Remediation plays a pivotal role in driving simplification, standardization, and compliance of products within the framework of the Consent Decree (CD) response. This position is integral to the Product Remediation effort, focusing on design and development, Corrective and Preventive Actions (CAPA), and the associated process and production controls across global manufacturing sites. As a leader in this domain, the individual will provide vision and strategy while managing complex problems and addressing challenging issues that arise in the course of product development and compliance. In this role, the Sr. Program Manager will act as a project manager, collaborating closely with business and R&D leadership to ensure that the product portfolio aligns with current needs and future innovation roadmaps. This includes delivering on commitments to patients and managing audit outcomes effectively. The individual will be responsible for integrating self-audit findings into processes that define products, ensuring that all aspects of product development meet regulatory and quality standards. The position requires accountability for the program plan and schedule, resolving interdependencies with other workstreams related to the Consent Decree. The Sr. Program Manager will represent Product & Process Development and Remediation in Project Management Office (PMO) governance mechanisms, serving as the single point of accountability for communicating status updates, escalations, and other critical information to executives at various levels within the Sleep & Respiratory Care (S&RC) division.

Responsibilities

  • Drive simplification and standardization of product compliance in global manufacturing sites.
  • Manage complex problems and address difficult issues related to product development and compliance.
  • Act as project manager, partnering with business and R&D leadership to align product portfolios with innovation and patient commitments.
  • Manage audit outcomes and integrate self-audit findings into product processes.
  • Accountable for the program plan and schedule, resolving interdependencies with other CD workstreams.
  • Represent Product & Process Development and Remediation in PMO governance mechanisms, communicating status and escalations to executives.

Requirements

  • 8+ years of related experience in program and portfolio management in a matrixed environment.
  • Proven business experience in innovation, product development, quality assurance, and operations.
  • Experience in leading process improvement methodologies such as Lean, Hoshin, or 6-sigma.
  • Strong understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820).
  • Knowledge of medical device process requirements.
  • Master's degree in science, engineering, or a related field; PMP Certification preferred.
  • Excellent executive communication skills and ability to build peer-to-peer relationships with stakeholders.

Nice-to-haves

  • Experience in the healthcare technology sector.
  • Familiarity with CAPA management processes.
  • Ability to navigate complex regulatory environments.

Benefits

  • Generous PTO
  • 401k with up to 7% match
  • Health Savings Account (HSA) with company contribution
  • Stock purchase plan
  • Education reimbursement
  • Annual incentive bonus
  • Long-term incentives
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