All the health information we need is within us. Just below the skin. SAVA is redefining the way people interact with their health by developing the most advanced biosensing technology science has to offer, capable of accessing bodily information in a painless, real-time and affordable way.
We're seeking a passionate Senior Validation Engineer to lead the validation of manufacturing processes, equipment, software and measurement systems as we scale the manufacture of our medical devices. Reporting to the Process Development Team, you'll work at the intersection of engineering, quality and regulatory affairs, ensuring manufacturing systems are scientifically justified, appropriately qualified and capable of consistently producing high-quality products.
You'll collaborate across internal teams including Sensor Development, Automated Equipment, Mechanical Engineering, Manufacturing, Data Engineering, Regulatory and Quality, as well as external suppliers, to define validation strategies, coordinate qualification activities, and maintain the validated state throughout the product lifecycle. This role is ideal for an engineer who enjoys solving technical problems, applying statistical thinking, and bringing structure to complex engineering programmes without losing sight of the underlying science.
If you want to directly shape how a novel medical device reaches patients, keep reading.
You will own the validation strategy for manufacturing processes, equipment, software, and measurement systems. Working closely with technical subject matter experts, you'll translate engineering knowledge into robust validation plans, ensuring manufacturing capability is demonstrated through appropriate scientific rationale, statistical evidence, and regulatory-compliant documentation. This role is inherently high ownership and high agency to enable you to drive quickly towards critical milestones.
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Own and maintain the Manufacturing Validation Master Plan.
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Develop risk-based validation strategies for manufacturing processes, equipment, software and measurement systems.
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Define qualification approaches including IQ, OQ, PQ, Test Method Validation (TMV) and software validation.
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Establish sampling plans, acceptance criteria and statistical rationale.
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Author, review and approve validation protocols and reports.
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Coordinate and, where appropriate, execute validation activities alongside engineering teams.
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Ensure validation evidence is complete, traceable and inspection-ready.
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Work closely with Process Development, Automation, Mechanical Engineering and Data Engineering teams to understand process capability and translate technical knowledge into validation strategies.
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Provide technical guidance on validation requirements during process development and equipment design.
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Lead validation projects from planning through completion.
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Coordinate activities across Engineering, Manufacturing, Quality, Regulatory and external suppliers.
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Manage validation schedules, dependencies, risks and stakeholder communications.
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Degree in Engineering (Manufacturing, Mechanical, Industrial, or Biomedical)
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3–5 years of experience in process development or manufacturing engineering in a regulated industry, preferably under ISO 13485
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Demonstrated experience developing and executing validation strategies for manufacturing processes, equipment, software or test methods.
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Strong understanding of process qualification methodologies including IQ, OQ, PQ, Test Method Validation (TMV) and Measurement System Analysis (MSA).
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Comfortable developing pragmatic, risk-based validation strategies for evolving manufacturing processes in a fast-paced development environment.
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Strong background in experimental design, statistical analysis and risk-based decision making.
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Experience defining acceptance criteria, sampling strategies and statistical justification for validation activities.
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Strong communication and project management skills with the ability to explain complex technical concepts to both engineering and non-engineering stakeholders.
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Experience with data-driven process control, manufacturing dashboards, or metrics development
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Experience with software validation or validation of automated manufacturing equipment.
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Experience maintaining Validation Master Plans or validation programmes across multiple manufacturing processes.
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Familiarity with FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 14971 or GAMP 5.
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Proficiency in statistical tools (e.g., JMP, Minitab, or similar)
This is a high-ownership, high-responsibility role in a company that’s building something complex, meaningful, and fast. The expectations are high, the learning curve is steep, and the work is often messy, but the impact is real. You can directly shape how a novel medical device reaches people.
We don’t have room for egos or passengers. What we do have is a team of thoughtful, driven, and mission-aligned people committed to building something better and doing it with urgency and integrity.
