AuST Group is seeking a Manufacturing Process Control Engineer: o support and improve our production processes. This role plays a key part in driving efficiency, quality, and continuous improvement across our manufacturing operations while collaborating closely with production, quality, and engineering teams.
Roles and Responsibilities: Monitor real-time process performance using dashboards, SPC, and MES. We are looking for someone to provide ownership over process and tooling in real time, providing stabilization services.
- 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 Focal Point for Technical Interactions:
- 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 roadmapAll roles will have the following tasks and responsibilities associated with their individual contributions
- 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
Proof of eligibility to work in the United States must be provided if selected for hire
Job Type: Full-time
Pay: $70,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Education:
Experience:
- Manufacturing Engineering: 1 year (Required)
Work Location: In person
