DEKA Research and Development Corporation

Process Controls Engineer - High Purity Water Subsystems

DEKA Research and Development Corporation • $80K — $110K *
Manchester, NH 03103In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
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Job Overview by Ladders

Qualifications

  • BS or MS in Controls, Chemical, Mechanical, Biomedical Engineering, or related field.
  • 2+ years in regulated device development with experience in high-purity water systems.
  • Knowledge of WFI and water generation technologies including RO and distillation.
  • Familiar with regulatory standards including USP and FDA 21 CFR.
  • Experience with FMEA and protocol development for device qualification.
  • Proven ability to lead cross-functional teams in a complex environment.
  • Strong communication skills for presenting to regulatory and executive stakeholders.

Responsibilities

  • Define control architecture for water purification systems.
  • Architect interfaces between water subsystem and device controls.
  • Own requirements and control narratives throughout development.
  • Lead risk management per ISO 14971 to ensure patient safety.
  • Drive validation strategies for water quality and integrity.
  • Guide cross-functional teams balancing performance and manufacturability.
  • Contribute to critical documentation throughout device development.
  • Support program management in aligning technical and regulatory milestones.

Benefits

  • Opportunity to work on cutting-edge regulated device platforms.
  • Engagement with cross-functional teams to drive product innovation.
  • Involvement in all phases of product development from concept to market fruition.
  • Contribution to ensuring patient safety and device compliance.
  • Exposure to regulatory frameworks and hands-on experience with compliance processes.
Full Job Description
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.


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 generation technologies (RO, EDI, ultrafiltration, distillation), onboard distribution system design, and inline water quality monitoring.
  • Regulatory fluency across USP , USP , USP , USP , 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.


Preferred Qualifications:
  • 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.

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About DEKA Research and Development Corporation

DEKA Research and Development Corporation is a research and development company based in Manchester, New Hampshire. The company was founded in 1982 by Dean Kamen, an inventor and entrepreneur who has over 440 patents to his name. DEKA is known for developing innovative technologies in a variety of fields, including medical devices, robotics, and transportation. Some of the company's most notable inventions include the Segway personal transporter, the iBOT mobility system, and the DEKA Arm prosthetic limb. DEKA has received numerous awards and accolades for its work, including the National Medal of Technology and Innovation in 2000.
Learn more about DEKA Research and Development Corporation
Size
1,000 employees
Industry
Aerospace & Defense
Founded
1982
* Ladders Estimates

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