Top 3930 Medical device validation Jobs

Director of Technical Operations
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- Full-time
- 5 years
- Bachelor of Science
- Mentoring
- Health savings account
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Quick Apply
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Manufacturing Engineer - Senior
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Senior Manufacturing Engineer
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NPI Engineering Technician
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Quality Systems Engineer - Supplier Quality
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AuST Manufacturing —West Valley City, UT
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Electrical Engineer - Medical Devices
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13d
GTS Service Technician I
Packaging Technologies & Inspection, LLC —Hawthorne, NY
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R&D Engineering Manager
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Senior Electrical Engineer
CooperSurgical —Trumbull, CT
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SR Electrical Engineer - Board Design (7+ years experience Hardware Design)
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3d
Quality Engineer
Clinical Diagnostic Solutions, Inc. —Plantation, FL
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13d
Mechanical Inspector Coordinate Measuring Machine Operator - IV
Investigo LLC —Ayer, MA
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CNC Milling Machinist
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Director of Technical Operations

AuST Manufacturing
West Valley City, UT

Quick Apply

Job Details

Full-time
11 days ago

Benefits

Health savings account
Relocation assistance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Flexible schedule
Life insurance
Retirement plan

Qualifications

Industrial equipment design
Manufacturing management
Human-machine interface (HMI) systems
Operations management
Machine vision systems
Bachelor of Science
Dimensional inspection
Control system design
Industrial equipment troubleshooting
Manufacturing facility
PLC systems installation and repair
Dimensional measurements
Mechatronics engineering
Managing engineering teams
Production validation processes
Medical device manufacturing facility experience
Design engineering
Vision inspection system
Optical comparators
Biomedical manufacturing processes
Commissioning phase involvement
Ladder logic (LD)
Mechanical product validation projects
Mechanical troubleshooting
Debugging

Full Job Description

About AuST Group

AuST Group is a premier medical device design, development, and high-volume manufacturer specializing in minimally invasive cardiovascular catheter technologies. "AuST" represents the gold (Au) standard (ST) — we hold ourselves to it in everything we build and everything we do. Our products require extreme precision, and so do the people who lead our technical operations.

The Opportunity

We are building an automation-forward Technical Operations organization and need a working technical leader — someone who has personally designed, built, debugged, and validated automated manufacturing equipment and can now lead a team doing the same. This is not a seat-in-the-conference-room role. You will be on the floor, in the data, at the machine.

You will directly lead specialized technical teams: Advance equipment, automation and laser technologies. Your job is to be the most technically capable person in the room — while simultaneously developing your team, driving compliance, and delivering results against cost, quality, and throughput targets.

If your résumé shows 15 years of managing people but you have not personally written PLC logic, commissioned a custom-built machine, or troubleshot a laser process in a cleanroom, this role is not for you. If it shows the opposite — deep hands-on automation and laser expertise, supported by growing leadership capability — read on.

What You Will Own

Automation Engineering and Advanced Equipment — Design, Build, Deploy

Personally lead the design and commissioning of custom automated assembly equipment for catheter manufacturing: fixturing, subassembly automation, test stations, and material handling systems
Write and review PLC logic (Beckhoff, Siemens, or equivalent); develop HMI interfaces and integrate vision systems for inline inspection and dimensional verification, microcontroller system design
Select, specify, and work alongside machine builders and systems integrators; provide hands-on technical oversight from concept through IQ/OQ/PQ validation
Develop and maintain control plans, qualification protocols, and change control packages in compliance with FDA QSR, MDR and ISO 13485
Build out a multi-year automation roadmap aligned to throughput growth, yield improvement, and headcount leverage goals

Laser Process Engineering — Technical Authority

Serve as internal technical authority on laser-based manufacturing processes (cutting, welding, marking, ablation) applied to catheter components and assemblies
Define and own laser process parameters (wavelength, pulse duration, fluence, spot geometry) and validate critical process windows with formal DOE methodology
Manage laser equipment fleet: enable scheduled PM, performance qualification, troubleshooting, and supplier relationships
Partner with R&D and process engineering on new product introductions requiring laser process development and scale-up
Lead investigations on laser-related deviations, NCRs, and yield losses using structured A3 / DMAIC methodologies

Technical Operations Leadership

Directly manage and develop direct reports and teams: Advanced Equipment, Automation Engineer and Laser Process Engineer; provide coaching, technical mentorship, and career growth planning
Define and uphold Technical Operations strategy, standards, budget and execution.
Support OEE, uptime, scrap, and throughput KPIs for all automated and laser-equipped production cells; build visual management systems and daily accountability routines
Lead complex cross-functional investigations (deviations, CAPAs, NCRs) to verified root cause and sustainable corrective action
Manage capital projects from business case through installation and qualification; develop and execute equipment justification packages with ROI analysis
Lead gemba walks, kaizen events, and WSVA assessments to drive waste elimination and flow optimization across the production floor
Champion 6S, standard work, and visual management as daily practices, not periodic programs

Quality, Compliance, and Regulatory Interface

Maintain full compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971 across all process technology and automation systems
Own process validation documentation (pFMEA, process qualification protocols, master validation plans, validation reports) with technical accuracy and completeness
Serve as technical authority during customer audits, regulatory inspections, and supplier qualification activities
Lead change control and risk assessment for all automation and process technology changes

Who You Are — Required Profile

We are looking for a specific person. If the statements below describe you, we want to talk:

You have personally designed and built automated manufacturing equipment — not supervised a vendor who built it, but done the mechanical design, electrical integration, control programming, and bring-up yourself (or as a primary hands-on contributor)
You have 8+ years of progressively deeper automation engineering experience in a regulated manufacturing environment (medical device, pharmaceutical, aerospace, or equivalent)
You have direct experience with laser-based manufacturing processes — you understand beam physics, optics, process parameter development, and equipment maintenance at a practitioner level
You are PLC-proficient: you have written and debugged ladder logic, function block diagrams, or structured text in production environments (Allen-Bradley ControlLogix / CompactLogix, Siemens S7, or equivalent)
You have specified, selected, and commissioned machine vision systems (Cognex, Keyence, or equivalent) for dimensional inspection or assembly verification
You have led IQ/OQ/PQ validation of automated equipment in a regulated quality system
You have 5+ years of people leadership experience — not as your primary identity, but as a natural extension of technical credibility
You hold a BS or higher in Mechanical Engineering, Electrical Engineering, Mechatronics, or a related technical discipline

Preferred Qualifications

Direct experience in catheter, tubing, or other flexible medical device manufacturing
Lean Six Sigma Black Belt or equivalent certification with documented project results
Experience with fiber laser, CO2 laser, or ultrashort-pulse (femtosecond / picosecond) laser systems in a manufacturing context
Hands-on experience with collaborative and industrial robots (FANUC, KUKA, Universal Robots, or equivalent) including EOAT design and safety integration
Proficiency with SolidWorks, AutoCAD, or equivalent CAD tools for fixture and machine design
Familiarity with PLM, ERP, MES, SCADA, and data historian systems; experience using manufacturing data for process control decisions
Experience leading capital projects exceeding $500K from justification through qualification
Locality to Salt Lake City, Utah strongly preferred — this role is fully in-person and connected to the production floor

Why AuST Group

You will have real technical authority and a defined automation roadmap to execute — this is not a role where you will spend your time asking for permission to build things
AuST is at an early stage of lean and automation maturity — your work will have a visible, lasting impact on how this company manufactures
You will be working on cardiovascular catheter products where precision matters, quality is non-negotiable, and what you build ends up inside patients
Direct access to senior leadership and a culture that values data-driven decision-making and operational discipline.

Job Type: Full-time

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Relocation assistance
Retirement plan
Vision insurance

Experience:

Technical Operations, Manufacturing or Process Engineering : 10 years (Preferred)

Ability to Commute:

West Valley City, UT 84119 (Preferred)

Work Location: In person

Quick Apply

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