Process Controls Engineer – High Purity Water Subsystems

DEKA Research & Development • Manchester, NH

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About The Position

We are looking for a Process Controls Engineer to own the design, integration, and qualification of high purity water subsystems embedded within a complex, multi-disciplinary regulated device platform. You will play a critical role in ensuring onboard water purity performance, subsystem reliability, and regulatory compliance across the full device development lifecycle.

How you will make an impact as a Process Controls Engineer:
Define process control architecture for onboard high purity water generation, purification, storage, distribution, and quality monitoring systems, and develop control specifications that drive consistency and compliance across the subsystem and its interfaces with the broader device.
Architect control interfaces between the water subsystem and the host device's embedded controls, sensor networks, onboard diagnostics, and cloud monitoring platforms.
Own subsystem requirements and control narratives end-to-end, from concept through IQ/OQ/PQ qualification and routine water quality monitoring.
Lead hazard analysis and risk management per ISO 14971, identifying and mitigating risks to water purity integrity, sterility, device performance, and patient safety.
Drive subsystem validation strategies covering statistical process control, data integrity (21 CFR Part 11), conductivity and TOC monitoring, microbial and endotoxin control, WFI qualification, and fluid pathway integrity testing.
Guide cross-functional teams across fluidics, electrical, embedded software, and manufacturing, balancing purity performance against device-level SWaP, cost, and manufacturability constraints.
Contribute to DHF documentation, PFMEA reviews, design reviews, and traceability matrices throughout the device development program.
Support program management by estimating effort, surfacing technical risks, and aligning project plans with qualification and regulatory milestones.

Requirements

• BS or MS in Controls Engineering, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
• 2+ years in a regulated device development environment with hands-on experience designing, integrating, and qualifying high purity water or fluid handling subsystems.
• Working knowledge of WFI and purified water generation technologies (RO, EDI, ultrafiltration, distillation), onboard distribution system design, and inline water quality monitoring.
• Regulatory fluency across USP <1231>, USP <645>, USP <643>, USP <85>, 21 CFR Parts 210/211/820, 21 CFR Part 11, GAMP 5, ISO 13485, and ISO 14971.
• Hands-on experience with FMEA, DFMEA, PFMEA, hazard analysis, and IQ/OQ/PQ protocol development and execution.
• Proven ability to guide cross-functional teams and drive alignment across quality, regulatory, fluidics, software, and manufacturing stakeholders.
• Strong written and verbal communication skills with the ability to support presenting complex subsystem data to regulatory bodies and executive leadership.

Nice To Haves

• Experience with onboard WFI generation and sterile water subsystems within aseptic processing or drug delivery devices.
• Familiarity with cloud-connected water quality monitoring, remote diagnostics, and cybersecurity considerations for networked subsystems.
• Experience supporting FDA or EMA regulatory inspections related to high purity water system qualification and monitoring.
• Knowledge of SWaP-optimized purification technologies and miniaturized onboard water system design.
• Familiarity with MBSE methodologies (SysML, Cameo) for subsystem interface definition and requirements traceability.

Responsibilities

• Define process control architecture for onboard high purity water generation, purification, storage, distribution, and quality monitoring systems, and develop control specifications that drive consistency and compliance across the subsystem and its interfaces with the broader device.
• Architect control interfaces between the water subsystem and the host device's embedded controls, sensor networks, onboard diagnostics, and cloud monitoring platforms.
• Own subsystem requirements and control narratives end-to-end, from concept through IQ/OQ/PQ qualification and routine water quality monitoring.
• Lead hazard analysis and risk management per ISO 14971, identifying and mitigating risks to water purity integrity, sterility, device performance, and patient safety.
• Drive subsystem validation strategies covering statistical process control, data integrity (21 CFR Part 11), conductivity and TOC monitoring, microbial and endotoxin control, WFI qualification, and fluid pathway integrity testing.
• Guide cross-functional teams across fluidics, electrical, embedded software, and manufacturing, balancing purity performance against device-level SWaP, cost, and manufacturability constraints.
• Contribute to DHF documentation, PFMEA reviews, design reviews, and traceability matrices throughout the device development program.
• Support program management by estimating effort, surfacing technical risks, and aligning project plans with qualification and regulatory milestones.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees