Project Manager

Abram Scientific is a startup company, located in Menlo Park, CA that is dedicated to creating fast hemostasis information for point-of-care use, to improve patient outcomes in surgical, emergency rooms or trauma centers.

Abram Scientific is seeking an experienced Engineering Project Manager to lead the planning, execution, and coordination of cross-functional product development programs. This individual will serve as the operational hub of the engineering organization, ensuring that projects remain on schedule, within budget, and aligned with company objectives.

The ideal candidate is a highly organized technical project manager who understands the medical device product development lifecycle and can effectively coordinate engineering, quality, regulatory, manufacturing, clinical, and operations teams. This role is responsible for driving accountability, identifying risks early, facilitating decision‑making, and ensuring successful execution from concept through commercialization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Project and Program Management

• Develop and maintain integrated project plans covering hardware, software, consumables, assay development, manufacturing, quality, regulatory, and clinical activities.
• Define project scope, schedules, milestones, critical paths, dependencies, and resource requirements.
• Drive projects from concept through design, verification, validation, manufacturing scale‑up, regulatory submission, and commercialization.
• Monitor project progress and proactively manage risks, issues, and schedule changes.
• Ensure cross‑functional alignment and timely execution of project deliverables.
• Facilitate weekly project meetings, design reviews, and program status updates.
• Track action items and ensure timely resolution of technical and operational issues.
• Escalate risks and decisions appropriately while maintaining project momentum.
  

Product Development Process

• Support execution of Design Controls in accordance with FDA and ISO 13485 requirements.
• Ensure project documentation supports Design History File (DHF) requirements.
• Coordinate design reviews, verification and validation activities, and design transfer milestones.
• Work closely with Quality and Regulatory teams to maintain compliance throughout product development.

Manufacturing

• Coordinate engineering activities supporting prototype builds, pilot manufacturing, and production scale‑up.
• Collaborate with manufacturing engineering to ensure readiness for design transfer.
• Support supplier qualification, manufacturing readiness reviews, and production planning.

Resource & Budget Management

• Track engineering resource utilization and project budgets.
• Assist leadership with project prioritization and capacity planning.
• Identify potential resource constraints and recommend mitigation strategies.

Communication & Reporting

• Communicate project progress, risks, and key decisions to leadership and stakeholders.
• Maintain project documentation and meeting records.
• Improve project management processes, templates, and reporting tools.
• Drive adoption of best practices in project planning, risk management, and cross‑functional communication.
• Support implementation and optimization of project management and collaboration tools.

QUALIFICATIONS AND EXPERIENCE

Education and Industry Experience:

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field.
• 5+ years of engineering project or program management experience in medical devices, biotechnology, diagnostics, or other regulated industries.

Technical Knowledge:

• Strong understanding of the medical device product development lifecycle from concept through commercialization.
• Demonstrated experience managing complex, cross‑functional engineering programs.
• Experience supporting manufacturing scale‑up and new product introduction (NPI).
• Familiarity with ISO 14971 risk management and IEC 60601 product development.
• Experience working with contract manufacturers and external development partners.
• Familiarity with PLM, ERP, and electronic Quality Management Systems (eQMS)
• Experience with Design Controls, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and Design History Files (DHF).
• Strong project planning and scheduling skills using Microsoft Project, Smartsheet, Monday.com, Jira, or similar project management tools.
• Strong attention to detail.
• Excellent organizational, leadership, and communication skills.
• Proven ability to manage multiple projects in a fast‑paced startup environment.

Preferred Qualifications:

• Experience with Class II or Class III medical devices.
• Experience with point‑of‑care diagnostics, IVDs, or laboratory instrumentation.
• Experience supporting FDA 510(k) submissions.
• PMP certification or equivalent project management certification.

The ideal candidate:

• Thrives in a dynamic startup environment where priorities evolve quickly.
• Is highly organized, proactive, and execution‑oriented.
• Can communicate effectively with engineers, executives, suppliers, and external partners.
• Balances attention to detail with a strategic view of program objectives.
• Builds trust across cross‑functional teams and drives accountability without direct authority.
• Anticipates risks and develops practical mitigation strategies.
• Is comfortable managing multiple complex projects simultaneously.

Job Requirements:

• This position will involve repetitive work utilizing computer equipment and data entry 90% of the time.
• The position may require frequent sitting, reaching, reading, looking, standing, stooping, bending, pushing, pulling, walking, turning, twisting.
• The position may require occasional lifting.