Process Controls Engineer – Integrated Clean Environments
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Job Location:
Manchester, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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:
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 devices utility and control systems.
- Architect control interfaces between the onboard clean environment subsystem and the host devices 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).
- 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 DEKAs 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.
Required Experience:
Junior IC
Key Skills
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more
