Senior Project Manager Medical Device Manufacturing AccelerateRPM LLC Irvine, CA Job Details Full-time | Contract From $80 an hour 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Developing medical devices Product design project leadership Managing medical device teams Project development phase management Teamwork New product introduction engineering projects Management Communication platforms Production validation processes Bachelor's degree Quality risk management Medical device manufacturing facility experience Project management experience in healthcare Collaborative technology platforms Leading team collaboration initiatives Schedule creation Quality standards in production Agile Design controls Biomedical regulatory compliance Managing projects Root cause analysis Microsoft Project Cross-functional team management Project risk management Technical Proficiency Project stakeholder communication Cross-functional communication FDA regulations Full Job Description 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:

Bachelor's (Required)

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