Process Controls Engineer - High Purity Water Subsystems in Manchester

Job DescriptionJob DescriptionWe 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 , 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.

Required Qualifications:

• 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 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.

Qualifications:

• Experience with onboard WFI 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.

About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern .

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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