Careers

AI and Machine Learning Scientist

Company: Biomedisca, Inc. , AI Development Division

Type: Contract (Remote)

Duration: 3–6 months | Extension possible

 

Responsibilities

• Design, train, and optimize AI/deep learning models (CNNs, transformers, segmentation networks) for medical imaging.

• Build end-to-end training pipelines for preprocessing, augmentation, and performance evaluation.

• Manage large-scale image annotation and dataset curation with precision and reproducibility.

• Validate models through metrics such as accuracy, sensitivity, specificity, and AUC.

• Integrate trained models into mobile and web-based diagnostic platforms for real-time analysis.

• Collaborate with engineers, clinicians, and data scientists to align AI outputs with diagnostic standards.

• Document architectures, datasets, and validation workflows for regulatory compliance.

 

Required Skills

• Expertise in Python, TensorFlow, PyTorch, and OpenCV.

• Experience with radiographic imaging (X-ray, CT, MRI) and annotation tools (CVAT, Labelbox, Supervisely).

• Strong knowledge of image segmentation, classification, and feature extraction algorithms.

• Familiarity with DICOM standards and cloud deployment (AWS, GCP, Azure).

 

Preferred

Background in biomedical engineering, radiology AI, or applied computer vision research

Closed

Regulatory Affairs Specialist

Salary Range: $75,000 – $90,000 annually

 

Role Description

Biomedisca is seeking a Regulatory Affairs Specialist for a hybrid contract role. The Specialist will be instrumental in ensuring compliance with regulatory requirements, managing regulatory documentation, and preparing submissions to regulatory bodies. The position is based in Irvine, CA, with some flexibility for remote work.

 

Responsibilities

  • Ensure compliance with FDA regulations and MedTech industry standards.
  • Manage and maintain regulatory documentation, including technical files and quality system records.
  • Prepare and submit regulatory applications, such as 510(k), PMA, or other relevant filings.
  • Collaborate with cross-functional teams to gather required documentation for submissions.
  • Monitor changes in regulatory requirements and communicate updates to the team.
  • Provide regulatory guidance during product development and testing phases.
  • Serve as the primary point of contact for regulatory agencies during audits or reviews.

 

Qualifications

  • Strong understanding of FDA regulations and MedTech industry standards.
  • Demonstrated experience in regulatory compliance and regulatory affairs.
  • Proficiency in preparing and submitting regulatory filings.
  • Exceptional attention to detail and strong analytical skills.
  • Excellent written and verbal communication abilities.
  • Ability to work independently and collaboratively within a team environment.
  • Bachelor’s degree in Regulatory Affairs or a related field.

 

Preferred Experience

  • Knowledge of international regulatory standards, such as CE marking or ISO 13485, is a plus.
  • Familiarity with medical device classification and risk management processes.
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Project Manager

Salary Range: $110,000 – $140,000 annually

Job Description

We are seeking a dynamic and results-driven Project Manager to lead and oversee the successful development and commercialization of our medical device projects. The Project Manager will be responsible for managing cross-functional teams, ensuring compliance with regulatory requirements, and coordinating all aspects of the project life cycle from concept through to product launch. This individual will play a critical role in maintaining timelines, budgets, and quality standards, while also serving as the primary point of contact for stakeholders.

Key Responsibilities

  • Lead and manage the entire lifecycle of medical device projects, from conception to market launch.
  • Develop and execute project plans, including timelines, budgets, resource allocation, and risk management strategies
  • Ensure all project activities comply with medical device regulatory standards (e.g., FDA, CE, ISO) and quality management systems (e.g., ISO 13485).
  • Collaborate with cross-functional teams, including R&D, engineering, regulatory, quality assurance, marketing, and operations, to ensure project alignment and success.
  • Track project progress, deliverables, and milestones, providing regular updates to senior leadership and key stakeholders.
  • Identify project risks and develop mitigation strategies to ensure timely and cost-effective delivery.
  • Manage vendor and supplier relationships as needed, including negotiating contracts and overseeing external partnerships.
  • Coordinate and prepare necessary documentation for regulatory submissions, design reviews, and audits.
  • Drive continuous improvement initiatives and best practices in project management to optimize processes and outcomes.

Qualifications

  • Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree preferred).
  • Minimum of 5 years of experience in project management, preferably within the medical device industry.
  • Proven track record of successfully leading cross-functional teams and delivering projects on time and within budget.
  • Strong understanding of medical device regulations (FDA, CE, ISO) and quality standards (ISO 13485, GMP).
  • PMP or similar project management certification is a plus.
  • Excellent organizational, communication, and problem-solving skills.
  • Proficient in project management tools (e.g., Microsoft Project, Jira, Asana)

In addition to the base salary, many companies offer bonuses, stock options, and comprehensive benefits packages, including health insurance, retirement plans, and performance incentives.

Closed

Senior Research and Development Engineer

Salary Range: $120,000 – $150,000 annually

Company Description

Biomedisca is a leading MedTech innovation company based in Irvine, CA, that specializes in developing diagnostic medical devices for preventive healthcare. Our focus is on creating advanced real-time diagnostic tools to empower healthcare providers in offering proactive care and interventions. We are dedicated to revolutionizing preventive healthcare by improving patient lives through early diagnosis and preventive strategies, setting new standards in the industry.

Role Description

We are seeking a highly skilled and experienced Senior Research and Development Engineer to join our dynamic team. In this role, you will play a critical part in the development and innovation of cutting-edge diagnostic technologies. This is an exciting opportunity to contribute to high-impact projects that focus on improving patient outcomes and advancing healthcare.

 

Key Responsibilities

  • Lead and manage the research and development process for novel diagnostic devices, from conceptualization through to validation and testing.
  • Collaborate with cross-functional teams to ensure timely delivery of key milestones and project goals.
  • Conduct and oversee the application of advanced biomaterials and engineering solutions in the design of medical devices.
  • Analyze data and optimize diagnostic solutions, ensuring their effectiveness and regulatory compliance.
  • Develop technical documentation and assist in regulatory submissions to meet industry standards and FDA requirements.
  • Mentor junior engineers and provide technical leadership within the R&D team.

 

Requirements

  • Ph.D. or Master’s degree in Biomedical Engineering, Bioengineering, or a related field.
  • Minimum of 5 years of experience in medical device development, particularly in diagnostics.
  • Strong knowledge of biomaterials, engineering processes, and diagnostic technology.
  • Proven ability to lead projects from early development to market readiness, with a focus on innovation.
  • Familiarity with regulatory guidelines and compliance, including FDA standards.
  • Excellent problem-solving, leadership, and communication skills.

 

Why Join Us

  • Be part of a forward-thinking team dedicated to innovation and the advancement of diagnostic technologies in healthcare.
  • Competitive salary and benefits package, with opportunities for career growth and leadership roles.
  • Work on exciting and impactful projects that have the potential to make a significant difference in patient care.
Closed

Research and Development Engineer

Salary Range: $80,000 – $100,000 annually

Company Description

Biomedisca is a leading provider of innovative medical devices, healthcare consulting, and patient care services based in Irvine, CA. Our team of experienced professionals is dedicated to improving healthcare outcomes and making a positive impact on the world. We specialize in developing cutting-edge medical devices that address critical healthcare needs and providing expert consulting services to help our clients succeed. At Biomedisca, we’re committed to pushing the boundaries of healthcare innovation and improving the lives of patients around the world.

Role Description

This is a contract Research and Development (R&D) Engineer role with day-to-day tasks that include analyzing data, conducting research, testing new products, and developing new medical devices. This is an on-site role located in Irvine, CA.

Qualifications

  • Strong analytical skills and experience analyzing complex data
  • Experience in conducting research and leading Research and Development (R&D) projects
  • Expertise in testing new products and prototypes
  • Experience in product development and the medical device industry
  • Bachelor’s degree in Engineering or related field
  • Experience with CAD design software, such as SolidWorks, is a plus
  • Excellent organizational and communication skills
  • Ability to work independently and as part of a team
Closed