Project Manager

Who we are:

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment.

The mission of the role:

We are seeking a skilled Project Manager to oversee the development and implementation of regulated medical device products. This role involves leading cross-functional teams through all stages of product development, ensuring adherence to regulatory requirements, timelines, and budget constraints. The ideal candidate will have a strong background in project management within the medical device industry and a comprehensive understanding of regulatory standards.

This is a role for a mad multitasker that's super organized and likes details. You are someone who enjoys organizing teams, managing multiple projects at the same time, and affecting change in real time. You will be responsible for managing the execution of multiple complex projects and for the overall coordination, status, reporting, and stability of project-oriented work efforts. You are passionate about delivering high quality within assigned expectations. You connect to strategy and enjoy tactical execution; you don't mind rolling up your sleeves.

Your day-to-day:

• Lead and manage projects related to the development, manufacturing, and launch of regulated diagnostic medical device products.
• Develop project plans, timelines, and budgets, ensuring alignment with organizational goals and regulatory requirements.
• Coordinate cross-functional teams, including R&D, product development, regulatory affairs, quality assurance, systems integration, manufacturing, and marketing, to ensure seamless project execution.
• Co-host/Co-organize core team meetings with external partners for development, manufacturing, and launch of IVD medical device products.
• Drive project progress by identifying and resolving issues, mitigating risks, and managing changes effectively.
• Ensure compliance with relevant regulatory standards, including FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable guidelines.
• Collaborate with regulatory affairs to prepare and submit regulatory submissions, such as 510(k) premarket notifications, CE Mark applications, and regulatory approvals in other global markets.
• Communicate project status, milestones, and risks to stakeholders, including senior management, ensuring transparency and alignment with strategic objectives.
• Foster a culture of continuous improvement, implementing best practices and lessons learned from previous projects to optimize project outcomes.
• Stay informed about industry trends, regulatory changes, and advancements in medical device technology, incorporating relevant insights into project planning and execution.
• Act as liaison, problem solver, and facilitator.
• Maintain the strict confidentiality of sensitive information.
• Perform other job-related duties as assigned or required.

What it takes to do this job:

• Bachelor's degree in engineering, life sciences, or related field; advanced degree (e.g., MBA, MS) preferred.
• Proven successful experience (5+ years) in project management within the IVD medical device industry, including successful product development and commercialization.
• Strong understanding of regulatory requirements for medical devices, including FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other relevant guidelines.
• Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders.
• Excellent written and verbal communication skills.
• Proficiency in project management tools and software (e.g., Microsoft Project, Jira, Smartsheet) and familiarity with design control processes.
• PMP certification, a record of training of Project Management Professional (PMP) or other relevant project management certifications preferred.
• Experience with Agile or Lean methodologies is a plus.
• Familiarity with the design transfer and manufacturing of a regulated medical device is a plus.
• Ability to thrive in a fast-paced environment and manage multiple projects simultaneously. Able to adjust priorities as business needs change.
• Strong analytical, communication, documentation, presentation, and interpersonal skills; and the ability to work independently and lead in a team environment.

Who you are:

• You have a "do what it takes - no job is too small" team player and positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally.
• Your organizational skills, attention to detail, and ability to multi-task are excellent.
• You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to:

• Improve patient outcomes.
• Meaningfully impact the company's short-term and long-term success.
• Work collaboratively across all levels within the organization.
• Grow your role as you see fit.
• Learn everything there is to know about cancer diagnostic laboratory.
• Create an inspiring workplace.