R&D Program Manager- MMS Project Management

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.