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  • Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development.
  • Lead human factor engineering activities as per the regulatory guidelines.
  • Manage project and program budgets and timelines effectively.

Risk Management ISO 13485

6 jobs similar to Director, Development and Human Factor Engineering

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US

  • Manages complex cross-functional design and development projects on a first in class wearable device.
  • Works with cross-functional team to ensure timely and complete deliverable execution.
  • Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.

Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.

  • Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
  • Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
  • Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.

Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.

  • Develop new processes for medical devices and components.
  • Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required.
  • Lead cross-functional team to plan and implement changes and improvements to operational systems and processes.

Penumbra, Inc. is a global healthcare company focused on interventional therapies. They design, develop, manufacture and market innovative medical devices and have a strong focus on collaborative team culture.

$240,000–$255,000/yr
US

  • Lead a hematology program, overseeing all operational activities and strategic planning.
  • Provide leadership over CROs and vendors, ensuring timelines, quality, and budget expectations are met.
  • Collaborate with internal functional leads to drive integrated study execution, providing strategic direction.

Caribou Biosciences is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases using CRISPR genome-editing technology. They have a CAR-T cell therapy platform and headquarters in Berkeley, California.

US

  • Translate program strategy into integrated timelines, milestones, and deliverables.
  • Manage one or more highly complex R&D programs and/or high-profile partnerships.
  • Lead cross-functional program management activities supporting autoimmune clinical development programs.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.

$135,000–$175,000/yr
US

  • Develop the human factors engineering (HFE) strategy, implementation plans, technical bases, and safety basis documentation.
  • Evaluate the implementation of human factors engineering best practices in the development of safety-significant personnel activities.
  • Translate task analysis and safety analysis results into requirements for alarms, indications, controls, procedures, and training objectives.

Oklo Inc. focuses on developing fast fission power plants to deliver clean, reliable, and affordable energy at scale, establishing a domestic supply chain for critical radioisotopes, and advancing nuclear fuel recycling to convert nuclear waste into clean energy. They operate in a fast-paced, iterative startup culture that values execution, ownership, and agility over formality.