Process Controls Engineer – Integrated Clean Environments

• 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.

• 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 <1116> 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.

• 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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