AuST Group · 4 hours ago
Manufacturing Engineer
Salt Lake City, UT
Full-time
Onsite
Mid LevelAuST Group is seeking a Manufacturing Process Control Engineer to support and improve their production processes. This role is crucial for driving efficiency, quality, and continuous improvement across manufacturing operations while collaborating with various teams.
Health CareManufacturingMechanical DesignMedical Device
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
Accountable and responsible (the owner): Safety, NCR’s, Delivery, Yield (all shifts), CODE RED’s, and root cause investigations
Responsible (supports with tasks): SCAR’s, CAPA’s, WSVA’s, process development
Consulted and informed (gives input, knows output): 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
Required
Experience in manufacturing process control engineering
Ability to monitor real-time process performance using dashboards, SPC, and MES
Ownership over process and tooling in real time
Experience in maintaining and controlling validated ranges and ensuring adherence to manufacturing instructions and control plans
Ability to investigate process deviations, non-conformances, and yield drops
Experience in collaborating with cross-functional teams to triage daily line issues
Ability to support CAPA investigations by providing data analysis and control system insights
Experience in conducting periodic audits of process parameters, equipment calibration, and operator adherence
Ability to maintain and update process documentation
Experience in supporting implementation and maintenance of automated control systems (PLC, SCADA)
Ability to train trainers, operators, and leads on critical control processes
Experience in participating in workstation vulnerability assessments
Ability to interface with quality and regulatory teams to ensure compliance with ISO 13485 and ISO 14971
Experience in supporting off-shift troubleshooting and providing remote monitoring capabilities
Ability to ensure process control strategies are aligned with risk management outputs
Experience in creating, maintaining, and continuously improving online designs, 6S standards, and standard work
Customer-facing experience to understand concerns, issues, and requests
Ability to create project timelines/charters and align key resources on key deliverables
Experience in aligning internal technical feedback to customers
Accountability for safety, NCR's, delivery, yield, CODE RED's, and root cause investigations
Support for SCAR's, CAPA's, WSVA's, and process development
Experience in serving as leadership backup to production within cross-functional teams
Ability to maintain site examples of operational excellence
Experience in engineering with continuous improvement and engineering obsolescence in mind
Ability to maintain an all-support mentality
Proof of eligibility to work in the United States must be provided if selected for hire
Company
AuST Group
AuST is a medical device design, development, and manufacturing firm specializing in minimally invasive medical devices.
Founded in 2009
201-500 employees
H1B Sponsorship
AuST Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Growth StageLeadership Team
Christian S. Eversull
Founder & Principal
Company data provided by crunchbase