Systems Integration Manager

Who we are:

Oncocyte is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.

Mission of the role:

The Systems Integration Manager will be a key member of the team responsible for defining product strategy, scope, and launch decisions for IVD products. This role will be responsible for ensuring a seamless integration of the IVD products from a system level through collaboration with internal and external stakeholders. The role will work cross-functionally to ensure the appropriate commercial, technical, regulatory, manufacturing, and logistics resources are available to support the successful execution of product strategy in IVD markets.

Your day-to-day:

• Work with a team of subject matter experts internally and externally from diverse fields to support OCX s diagnostics product portfolio from concept through development, verification and validation, design transfer, manufacturing, and commercialization
• Lead the definition and management of requirements and characterization of the systems/devices
• Define, plan, and coordinate formal technical design reviews
• Lead and complete system integration across multi-functional subject areas
• Lead risk management and hazard analysis activities
• Lead FMEA document generation in design, process, user error, and software
• Maintain system traceability matrix
• Support failure mode analysis and troubleshooting
• Coordinate with external vendors and CMOs to maintain production timeline and logistics
• Support in the design transfer to manufacturing
• Coordinate with external partners and consultants to ensure proper IVD SW development and V&V under FDA QMS and ISO13485 guidance
• Write system-related documents such as SOPs, QC, and IQ/OQ/PQ under the IVD product lifecycle
• Support the regulatory submissions, product labeling, and complex submissions issues
• Undertake other leadership and strategic tasks as assigned to support the organization's objectives. These may include cross-functional collaboration, process improvement initiatives, and addressing emerging business needs requiring managerial oversight.

What it takes to do this job:

• MS or above in engineering, biological science, physics, or chemistry
• 5 years of system-level integration and validation experience with a strong understanding of medical device design controls and change controls
• Proficient with Design Controls and Risk Management
• A significant contributor to IVD product development, delivered at least one project that was successfully launched under the US FDA or CE mark regulatory regime
• Experience mentoring and leading teams of technical contributors
• Ability to comprehend principles of engineering, physiology, and medical device use
• Knowledge of a wide range of disciplines in systems integration, including molecular biology and biochemistry, statistics, use of computers, and other analytic methods to solve problems in medical device development
• Basic molecular biology wet lab experience - including methods such as - sample extraction/preparation, dPCR, qPCR, or NGS is preferred
• Familiarity with QMS, 21 CFR 820, and ISO 13485 that supports medical device products for FDA and CE marking applications
• Software V&V protocol/experience is a plus

Who you are:

• You have a do what it takes no job is too small team player and a 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, and suppliers.

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 diagnostic laboratories.
• Create an inspiring workplace.