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AuST Group · 2 weeks ago

Manufacturing Engineer (Process Control)

West Valley City, UT

Full-time

Onsite

Entry Level

$70K/yr - $110K/yr

1+ years exp

AuST Group is seeking a Manufacturing Process Control Engineer to support and improve production processes. This role is essential for driving efficiency, quality, and continuous improvement across manufacturing operations while collaborating closely with various teams.

Health CareManufacturingMechanical DesignMedical Device

H1B Sponsor Likely

Responsibilities

Monitor real-time process performance using dashboards, SPC, and MES

Maintain and control validated ranges and ensure adherence to manufacturing instructions and control plans via on-the-line process analysis from material incoming to finished device outgoing

Investigate process deviations, non-conformances, and yield drops; initiate containment and corrective actions

Collaborate with cross-functional team to triage daily line issues, ensure process stability, and drive continuous improvement strategies

Support CAPA investigations by providing data analysis and control system insights

Conduct periodic audits of process parameters, equipment calibration, and operator adherence as the process and tooling SME

Maintain and update process documentation (e.g. manufacturing instructions, work instructions, control charts, lot records, walk patterns, and troubleshooting guides)

Support implementation and maintain automated control systems (PLC, SCADA) for critical processes, as available

Train trainers, operators and leads on critical control processes, alarm responses, and escalation protocols

Participate in workstation vulnerability assessments and perform tactical improvements based on outputs

Interface with quality and regulatory teams to ensure compliance with ISO 13485 and ISO 14971

Support off-shift troubleshooting and provide remote monitoring capabilities where applicable

Ensure process control strategies are aligned with risk management outputs (e.g., pFMEA, MVP’s, CCP’s)

Create, maintain and continuously improve online designs, 6S standards, standard work, etc

Customer facing role to understand concerns, issues, and requests

Understands project priorities internally and externally, creates project timelines/charters, and aligns key resources on key deliverables

Aligns all internal technical feedback to customers, shares communications with integrity, honesty, timeliness, & creates a positive environment/communication path

Safety, NCR’s, Delivery, Yield (all shifts), CODE RED’s, and root cause investigations

SCAR’s, CAPA’s, WSVA’s, process development

Process development, product roadmap

Serve as leadership backup to production within the respective cross-functional team level; leading meetings, delegating tasks, and tracking outputs

Maintain site examples of operational excellence: adhering to site requests, rules, and initiatives

Engineering with continuous improvement and engineering obsolescence in mind

Maintain an all-support mentality; provide support when required and needed

Other tasks and functions as directed by leadership

Qualification

Process ControlContinuous ImprovementData AnalysisPLCSCADAISO 13485ISO 14971TrainingCollaborationCommunication

Required

Bachelor's (Required)

Manufacturing Engineering: 1 year (Required)

Monitor real-time process performance using dashboards, SPC, and MES

Provide ownership over process and tooling in real time, providing stabilization services