Job Summary
Please note: This is an onsite job, no remote or hybrid option. Only candidates with at least 5 years of Medical Device Manufacturing project management will be considered, at least 1 year of New Product Development focus, and at least 10 years of Project Management role experience.
Thank you.
We are looking for a senior Project Manager with deep, practical experience leading new product development (NPD) projects in the medical device industry. You will own complex, cross-functional programs from concept through design transfer and manufacturing readiness, ensuring projects stay on track, compliant, and commercially viable.
This is a hands-on leadership role—not a pure process or PMO position. Success requires strong technical judgment, the ability to drive accountability across R&D, Quality, Manufacturing, Regulatory, and Supply Chain, and a track record of delivering results in a highly regulated environment. Methodology knowledge is useful; proven delivery experience is essential.
Key Responsibilities
- Lead end-to-end NPD projects for medical devices, including planning, execution, risk management, and design transfer into manufacturing.
- Drive cross-functional teams (R&D, Quality Assurance, Manufacturing, Regulatory Affairs, Supply Chain, and external partners) to meet technical, quality, timeline, and cost targets.
- Apply structured stage-gate / phase-gate processes appropriate for regulated medical devices while incorporating practical Agile or hybrid elements where they improve speed without compromising compliance.
- Own project schedules, resource plans, risk registers, and issue resolution. Proactively identify and mitigate technical, quality, supply, and timeline risks.
- Ensure rigorous adherence to design controls, design history file (DHF) requirements, risk management (ISO 14971), and applicable quality system standards (ISO 13485, 21 CFR 820).
- Facilitate clear requirements definition, design reviews, verification/validation planning, and process validation activities.
- Manage project documentation to audit-ready standards and support regulatory submissions as needed.
- Lead root-cause investigations and corrective actions when projects encounter technical or process issues.
- Communicate status, risks, and decisions clearly and concisely to technical teams and senior stakeholders.
- Continuously improve project execution through practical process improvements grounded in real project lessons rather than theoretical frameworks.
Required Experience & Qualifications
- 10+ years of progressive project management experience, with the majority spent leading medical device NPD or manufacturing transfer projects in a regulated environment.
- Demonstrated success delivering complex medical device projects on time and within quality/compliance requirements.
- Strong working knowledge of design controls, risk management, verification & validation, and design transfer processes.
- Proven ability to lead and influence cross-functional technical teams without direct authority.
- Practical experience with project scheduling tools (MS Project or equivalent) and collaboration platforms; tool proficiency is secondary to delivery results.
- Excellent written and verbal communication skills; able to translate technical issues for both engineering and executive audiences.
- Bachelor’s degree in engineering, science, or a related technical field required; PMP or equivalent certification is a plus but not a substitute for hands-on delivery experience.
Preferred
- Direct experience in ophthalmic, surgical, or other Class II/III medical devices.
- Exposure to manufacturing process validation, supplier qualification, or tech transfer activities.
- Experience working inside a large, matrixed medical device organization.
Pay: From $80.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Education:
Experience:
- Project Management : 10 years (Required)
- Medical Device Manufacturing: 5 years (Required)
Location:
- Lake Forest, CA 92630 (Preferred)
Ability to Commute:
- Lake Forest, CA 92630 (Required)
Work Location: In person
