Program Manager driving growth for Berkadia’s BeEngaged startup accelerator. Overseeing program design, marketing, and strategic insights with a focus on collaboration and execution.
About the role
- Senior Program Manager leading compliance and remediation programs within product development at Philips. Ensuring product quality and regulatory standards across global manufacturing sites.
Responsibilities
- Lead large-scale compliance and remediation programs tied to EU-MDR (European Medical Device Regulation) and U.S. Consent Decree initiatives.
- Develop and execute program strategies that drive simplification, standardization, and product quality across global manufacturing sites.
- Oversee complex project portfolios, by owning and aligning scope, schedule, and risk management with business and R&D goals.
- Partner with cross-functional teams to integrate audit findings, enhance Quality Systems, and improve CAPA and design control processes.
- Serve as a key voice within the PMO, communicating program status, risks, and results to senior leadership and stakeholders.
Requirements
- A minimum of 7+ years of experience leading program or portfolio management within product development, quality, or operations in a matrixed environment.
- A Bachelor’s degree is required or Master’s in Engineering, Science, or related field preferred (PMP certification is a plus).
- Proven success in problem solving and process improvement methodologies (Lean, Six Sigma, or Hoshin) and managing compliance-driven programs (e.g., EU-MDR, consent decrees, or recalls).
- Strong understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR 803/806/820, EU-MDR) and medical device development processes.
- Technical depth of electromechanical design, design history file requirements, and CAPA management is a plus.
- A collaborative leadership style with the ability to navigate complex challenges, influence stakeholders, and drive measurable impact.
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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