Process Controls Engineer - Integrated Clean Environments

DEKA Research & Development • Manchester, NH • 4h ago

We are looking for a Process Controls Engineer to own the design, integration, and qualification of clean environment subsystems embedded within a complex, multi-disciplinary regulated device platform. You will play a critical role in ensuring onboard environmental performance, contamination control, 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 micro clean environment subsystems integrated within a larger device platform, encompassing onboard environmental monitoring, precision airflow and pressurization control, contamination control, and integration with the host device's utility and control systems.

Architect control interfaces between the onboard clean environment subsystem and the host device's embedded controls, sensor networks, onboard diagnostics, and cloud-based environmental monitoring platforms.

Own subsystem requirements and control narratives end-to-end, from initial design and device-level integration through IQ/OQ/PQ qualification and routine onboard environmental monitoring programs.

Lead hazard analysis and risk management per ISO 14971, identifying and mitigating risks to onboard environmental integrity, product sterility, and patient or operator safety arising from subsystem failures or device-level interactions.

Drive subsystem qualification strategies covering onboard particulate monitoring, viable and non-viable sampling, pressure differential control, precision airflow verification, temperature and humidity control, and ISO 14644 classification within the operating conditions of the host device.

Guide cross-functional teams across device systems engineering, precision airflow, embedded software, instrumentation, quality, and manufacturing, balancing environmental performance against device-level SWaP, cost, and manufacturability constraints.

Contribute to DHF documentation, PFMEA reviews, subsystem design reviews, and traceability matrices throughout the device development program.

Support program management by estimating effort, surfacing technical risks specific to embedded clean environment subsystems, and aligning project plans with device-level qualification and regulatory milestones.

Required Qualifications:

BS or MS in Controls Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.

2+ years in a regulated device development environment with hands-on experience designing, integrating, and qualifying embedded environmental control subsystems within larger regulated devices. Medical device, pharmaceutical, biotech, or analytical instrument experience strongly preferred.

Working knowledge of ISO 14644 classification and monitoring at the micro zone level, precision onboard airflow and pressurization control, embedded EMS programming and integration, and onboard viable and non-viable particle monitoring within device-integrated controlled zones.

Regulatory fluency across ISO 14644-1/2, EU Annex 1, 21 CFR Parts 210/211/820, 21 CFR Part 11, GAMP 5, ISO 13485, ISO 14971, and USP as applied to embedded controlled environments within regulated devices.

Hands-on experience with FMEA, DFMEA, PFMEA, contamination control risk assessments, and IQ/OQ/PQ protocol development and execution for device-integrated clean zones.

Proven ability to work with cross-functional teams and drive alignment across systems engineering, embedded software, quality, microbiology, manufacturing, and regulatory stakeholders.

Strong written and verbal communication skills with the ability to support presenting subsystem qualification data and compliance status to regulatory inspectors and executive leadership.

Preferred Qualifications:

Direct experience with ISO 5 and ISO 7 clean environment design and qualification within an integrated device platform.

Familiarity with aseptic processing within device-integrated micro clean zones and contamination control requirements of sterile operations within a larger device.

Experience with onboard environmental monitoring platforms supporting 21 CFR Part 11 compliant electronic records and alarm management within a host device control framework.

Exposure to cloud-connected device architecture for remote environmental monitoring and cybersecurity considerations for networked subsystems (FDA cybersecurity guidance, IEC 81001-5-1).

Experience supporting FDA or EMA regulatory inspections related to embedded micro clean environment qualification and onboard environmental monitoring programs.

Knowledge of SWaP-optimized design principles including miniaturized filtration, precision variable airflow, and thermal management solutions for device-integrated controlled zones.

Familiarity with MBSE methodologies (SysML, Cameo) for subsystem interface definition and requirements traceability within a complex device architecture.

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 age.

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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