Job Description
Position Title: R&D Program Manager MMS Project Management Location: Onsite San Diego, CA preferred, but will also entertain Remote options Start Date: ASAP Length of Contract: 6 months + extension Interview Process: 1st round on Teams with hiring manager for 30-45 minutes, 2nd round will consist of 2-3 other team leads. Background Check Required Scope: This Program Manager will lead a cross-functional Core Team through a critical compliance program to achieve full certification for medical electrical equipment safety and essential performance standards. This Program Manager owns end-to-end program execution through regulatory clearance: gap analysis, risk-based roadmap development, design input/output updates, verification and validation (V&V) testing, design history file (DHF) compilation, and third-party certification. Duties and Responsibilities Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable). Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions. Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules. Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts. Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle. Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively. Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed. Foster a collaborative, innovative, and compliant culture within program teams. Qualifications & Requirements Required: Bachelor s degree in Engineering (Biomedical, Electrical, Mechanical, or related), 5+ years of experience in medical device product development, with at least 3 5 years in program/project management roles leading cross-functional teams. Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval). Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR). Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software. Excellent leadership, communication, and stakeholder management skills; ability to influence without direct authority.