Job Description

Position Summary

We are seeking an experienced Engineering Project Manager with medical device experience who thrives in a startup or high-growth environment. This role is ideal for a hands-on leader who is excited to build structure, define best practices, and help establish the project management operating model for the organization.

In addition to leading complex product development programs and supporting FDA submissions, you will help create, scale, and continuously improve project management processes that enable predictable execution and clear accountability across Engineering, Quality, Regulatory, Operations, and Product as the company grows.

Key Responsibilities (Additions & Enhancements)

Project Leadership & Execution

• Lead cross-functional teams through all phases of product development, from concept through commercialization, in a fast-paced, resource-constrained environment.
• Develop and maintain detailed project schedules, milestones, and resource plans; drive day-to-day execution through effective meeting cadence, action tracking, and follow-through.
• Drive clarity around scope, priorities, and ownership, and enable a clear decision-making process; proactively escalate issues with options and recommendations.
• Track and communicate project budget, BOM cost considerations, and resource allocation in partnership with functional owners.

Design Controls, Risk, and Regulatory Support

• Facilitate design control activities aligned to FDA 21 CFR 820 and ISO 13485, including design inputs/outputs, design reviews, and DHF readiness in collaboration with Quality/Regulatory.
• Partner with engineering and quality teams to plan and coordinate verification and validation (V&V) activities and ensure milestone readiness.
• Support risk management activities consistent with ISO 14971, ensuring risks, mitigations, and decisions are tracked and reviewed with appropriate stakeholders.
• Support planning and execution activities for FDA submissions and related documentation readiness.

Project Management Framework & Standards

• Design, implement, and continuously improve the company’s project management framework, including phase-gate or milestone models aligned to design controls; standardized plans and reporting; and risk/dependency/change-management practices.
• Maintain core program artifacts (integrated plan, RAID log, dependency tracker, decision log, change log) and drive consistent, concise status reporting.
• Identify gaps in process, communication, or tooling and implement improvements that increase predictability and accountability.

Cross-Functional Leadership & Communication

• Act as a unifying force across R&D/Engineering, Quality, Regulatory, Clinical, Marketing/Product, Manufacturing/Operations, and other stakeholders.
• Influence without authority by building trust and accountability in a matrixed environment.
• Ensure effective communication across all levels of the organization, including clear written updates and leadership-ready summaries.

Documentation & Systems

• Drive project documentation quality (accuracy, completeness, consistency) in alignment with the company’s quality management system (QMS).
• Support document routing and approvals using document control systems
• Support process improvements related to project management, design control, and change control.

Minimum Qualifications

• 5+ years of experience in engineering project/program management or a related cross-functional leadership role in the Medical Devices sector
• Working knowledge of Design Controls (21 CFR Part 820 / ISO 13485) and experience contributing to or maintaining Design History File (DHF) documentation.
• Experience driving schedules, dependencies, and risks across cross-functional teams; Strong bias toward action, ownership, and continuous improvement.
• Excellent verbal and written communication skills; strong conceptual, analytical, and problem-solving abilities.

Preferred Qualifications

• PMP certification and/or MBA a plus.
• Experience in a startup, early-stage, or high-growth environment.
• Familiarity with regulated product development practices, including verification/validation planning, risk management, and change control.
• Experience working with PLM/document control workflows.

Education

BS (MS preferred) in Engineering or a related field.

*Salary is dependent on education and experience.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore, the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

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