Arch Linux Iso Size Jobs in Usa

• Competitive base rate - $22.00-$32.20/ hour depending on experience.15% shift differential.
• Medical/Prescription Drug/Dental/Vision Benefits on Day 1 of employment
• 401(k) Retirement Savings Plan
  • 4.5% company match if you contribute at least 5%
• Quarterly Bonus potential
• Paid Time Off (PTO)
• 8 company paid holidays per year
• Employer paid Life Insurance, AD & D plus optional coverage for yourself, spouse and child(ren)
• Employee Assistance Program
• MN Paid Leave/and/or Short-Term Disability provided by ARCH
• $1,000 Sign on Bonus

• Inspects products during the machining operation to determine if parts meet specifications, complying with established standards and methods for inspection, testing, evaluation and calibration
• Follow all job work order instructions
• Must be able to run more than one machine where cycle time permits
• Complete all required shop floor documentation for the job including both part-dimensional and visual inspection
• Maintain equipment by completing preventive maintenance requirements; following manufacturer's instructions; troubleshooting malfunctions; reports to management/maintenance the need for machine repairs
• Understands and comply with company policy safety guidelines, quality systems requirements and housekeeping standards

• High school diploma or GED equivalent
• Due to contractual requirements, this position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

• Machine Tool Technology degree (completed or pursuing)
• A minimum of 1 years' experience operating a CNC Lathe machine
• Strong mechanical aptitude
• Ability to read and understand blueprints
• Strong attention to detail
• Effective verbal and written communication skills

McDonald's Works for Me.

Are you ready to take the next step in your career with a team that values your leadership, energy, and passion for people? At Iron Arch McDonald's, we're looking for dynamic, goal-oriented Shift Managers to lead our team through successful shifts while helping grow the business and develop our people.

The Job for Me This is your chance to inspire and lead. From managing day-to-day operations to mentoring team members and ensuring exceptional customer experiences, this role is about making an impact.

The Team for Me Are you a team player who thrives on energy and purpose? Do you enjoy coaching, solving challenges, and working in a fast-paced environment that delivers feel-good moments to guests? If so, you'll fit right in.

The Company for Me Iron Arch McDonald's offers more than just a job; it's a career with opportunities to grow, lead, and build a future. With competitive pay, world-class training, and benefits that matter, we're here to help you succeed.

What You'll Do

As a Shift Manager, you will:

• Lead shifts to ensure customers receive fast, accurate, and friendly service.
• Provide leadership to crew and managers during shifts, focusing on Quality, Service, and Cleanliness.
• Plan, monitor, and adjust operations to meet McDonald's standards and goals.
• Monitor safety, security, and profitability throughout your shift.
• Communicate effectively with the next Shift Manager to ensure smooth transitions.
• Support assigned Departments by helping meet team goals and targets.

You'll also be responsible for:

• Food Safety: Maintaining high standards and compliance with all procedures.
• Internal Communication: Keeping the team informed and motivated.
• Inventory Management: Monitoring and managing stock levels.
• Daily Maintenance and Cleanliness: Ensuring the restaurant is always guest-ready.
• Crew Management: Coaching, supporting, and leading team members.
• Quality Food Production: Ensuring food is prepared to the highest standards.
• Exceptional Customer Service: Creating memorable guest experiences.
• Safety and Security: Prioritizing the safety of guests and team members.
• Scheduling and Training: Supporting team development and operational excellence.

What We're Looking For

Our ideal candidate:

• Leadership Experience: Previous leadership experience is preferred, ideally in restaurants, retail, or hospitality.
• Team Player: Positive, flexible, and passionate about working in McDonald's fast-paced environment.
• Goal-Oriented: Focused on delivering results and building a great team.
• Must be 18 years or older.

Perks and Benefits

We believe in taking care of our team, and that includes incredible benefits:

• Paid Time Off: Earn PTO while growing your career.
• Education Opportunities: Access to Archways to Opportunity, including tuition assistance, high school completion programs, and English language classes.
• Health Coverage: Comprehensive medical, dental, and vision insurance.
• Retirement and Savings: Pre-tax flexible spending accounts and more.
• Additional Benefits:
• Paid leaves of absence.
• Short- and long-term disability, life, and accident insurance.
• Service awards and career recognition.

Why Iron Arch McDonald's?

This isn't just a job it's your chance to lead, grow, and make a difference. Let's talk. Make your move.

Apply today to join our team of leaders who are going places!

Wages Starting at $15 an hour

This job posting contains some information about what it is like to work in a McDonald's restaurant, but it is not a complete job description. People who work in a McDonald's restaurant perform a number of different tasks every day, and this posting does not list all of the essential functions of this job.

By applying to this position, I understand that I am applying to work at a restaurant that is owned and operated by an independent franchisee, not McDonald's USA. I understand that this franchisee is a separate company and a separate employer from McDonald's USA. Any information I provide in this application will be submitted only to the independent franchisee, who is the only company responsible for employment matters at this restaurant. I recognize that the independent franchisee alone will make all decisions concerning employment matters, including hiring, firing, discipline, supervision, staffing and scheduling. By applying for a job at a franchisee operated restaurant, I understand that the information I provide will be forwarded to the franchisee organization in order for that organization to reach out to me and process and evaluate my application. I acknowledge that McDonald's USA will not receive a copy of my employment application and will have no involvement in any employment decisions regarding me, including whether I receive an interview or whether I am hired to work for the franchisee. I understand that I need to contact the franchise organization for information about its privacy practices.

Skills / Technology : OS/Infrastructure (OS, Load Balancer, DNS, Storage, Firewall)

The Challenge

Client is seeking as UNIX Administrator with excellent technical, process and automation skills to be part of High-Performance Cloud Operations Team. As an Infrastructure Administrator, this person is responsible for the daily administration of Linux and Unix servers in a business application environment. This includes general system administration tasks, software and hardware support, system configuration, system monitoring. This person must have excellent Linux/Unix administration experience, with customer relation skills. Candidate should be able to work with business application administrators, helping troubleshoot their applications and guide them with standard methodologies. Candidate must be able to express thoughts clearly and capable of working in a team or as a sole contributor. Individual should be self-motivated with very good communication skills. Main point responsible for the overall operability, resiliency, performance, and capacity of owned production services.

What you’ll do

• System Administration - This person would be responsible for the day-to-day administration of all Linux based servers. This includes monitoring the trouble ticket queue, system troubleshooting, hardware and software system changes, scripting, patching, system performance monitoring, system sizing, system integration, upgrade implementation, and hardware diagnostics.
• Application support – This person would work with application administrators to help fix and fine-tune applications and also if required guide application administrators in standard processes related to using the underlying UNIX infrastructure.
• Documentation – Maintain all system documentation.

What you need to succeed

• Unix/Linux System Administration: In-depth experience with Unix/Linux servers (especially Suse, AIX, RHEL, CentOS) for installation, configuration, patching, and troubleshooting.
• Automation & Scripting: Proficiency in scripting (Bash, Python) and automation tools (Ansible, etc.) to streamline deployments and manage configurations.
• Demonstrable ability to perform UNIX builds,
• Understanding of RedHat Satellite, IBM NIM, or SUSE Manager for patch management.
• Networking Knowledge: Strong grasp of networking (TCP/IP, DNS, SSH, etc.) and system connectivity for effective troubleshooting in distributed environments.
• Working knowledge of Virtual machine management (VmWare, OpenShift) TCP/IP functionality, networking, Remote administration, cloning, migration, etc.
• Security Best Practices: Expertise in system security – user access controls, OS hardening, patch management, and compliance.
• Soft Skills: Strong communication, teamwork, and problem-solving skills to collaborate across teams and resolve complex issues efficiently.
• Operational experience with Ansible and Terraform are beneficial.

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

The Technical Project Manager (TPM) has three main responsibilities:

1. Project Manage all technical tasks during implementation and upgrades.
2. Install and configure servers and the Care Logistics applications in Amazon Web Services (AWS) and on premise.
3. Perform technical operations and oversee availability, performance, and supportability of our observability infrastructure.

The TPM acts as the project manager and liaison between Care Logistics and the customer for all technical activities. The TPM is responsible for coordinating the system configuration, sizing, ordering, and installation while technically engineering and managing the integration of Care Logistics solutions. They work closely with Solutions Delivery and customer resources in support of organizational objectives. Solutions Delivery functions include project delivery tasks such as solution sizing, technical project planning, customer guidance, system installation, system validation, system testing, technical training, and support of technical onsite events. The TPM facilitates DevOps functions between development and the Solutions Delivery teams to ensure technical operations are correctly executed, effectively communicated, and continuously improved.

ESSENTIAL RESPONSIBILITIES:

Solutions Delivery Functions

• Delivery components of customer project tasks which include:
• Assist with the design and implementation of new technologies
• Assist with the sizing of customer systems
• Train new employees on all aspects of the role
• Considered a Subject Matter Expert for all aspects of the technology and project delivery
• Install and troubleshoot software, hardware, and services necessary to support Care Logistics solutions
• Lead the engineering of hospital customer’s technical solutions
• Lead, plan, organize and drive the design, testing, and implementation of Care Logistics software solutions and related advisory services
• Educate customer on technical aspects of the Care Logistics system
• Interface with service and hardware system vendors to build and configure systems
• Participate in onsite customer events, including technical go-live
• Technical Operations and Observability:
• Manage alert and monitoring configuration
• Collect, aggregate, and visualize metrics to provide actionable insights
• Advise right-sizing of AWS infrastructure resources to optimize cost and performance
• Manage incident response
• Provide insight to Cloud Center of Excellence
• Additional tasks which include:
• Provide primary technical support for project team members
• Provide Tier 2 level support for Care Logistics Support team
• Create and maintain internal environments for use by Care Logistics Client Engagement team
• Create Knowledge Base articles and other technical documentation for use by Care Logistics employees and customers
• Define and maintain a clear, concise documented process for the implementation and integration of the system
• Collaborate with teammates to troubleshoot and maintain existing application modules
• Participate in DevOps initiatives to improve products and operations

QUALIFICATIONS – EDUCATION, WORK EXPERIENCE, CERTIFICATIONS:

REQUIRED

• Bachelor’s degree in Computer Information Systems or equivalent experience
• PMP certification and/or equivalent experience
• 2-4 years hands on experience using Amazon Web Services (AWS) services such as EC2, RDS, Systems Manager, VPN, CloudWatch
• 2-4 years of monitoring systems experience using tools such as AWS CloudWatch, Datadog, New Relic, SolarWinds, Dynatrace, etc.
• 4-6 years demonstrated project management experience
• Advanced operation and maintenance of Linux (Red Hat Operating System)
• Demonstrated advanced analytical and troubleshooting skills
• 3+ years integrating software/hardware systems in client-server and cloud environments
• Proven organizational and delivery skills

DESIRED

• AWS certification desired
• Automating and configuring Amazon Web Services (AWS) such as EC2, RDS, VPN
• Operational best practices related to systems operation and maintenance in on-premises and AWS production environments
• Industry standard application/applet containers such as Tomcat
• PostgreSQL and Aurora Databases (installation, configuration, and operation)
• Production High availability server environments
• Complex hardware and software installations
• Management of enterprise reporting tools and/or related technologies
• Project delivery, operations, and support using DevOps and/or Agile methods
• Support leadership experience
• Use of ticketing systems such as JIRA and/or related incident management tools such as OpsGenie
• Comprehension of related scientific and technical journals, abstracts, financial reports, and legal documents.
• Preparation of articles, abstracts, editorials, journals, manuals, and critiques.
• Preparation and delivery of comprehensive presentations, participation in formal debate, extemporaneous communication, and professional communication before an audience.
• Professional certifications in related industry skills such as DBMS, CISSP, ITIL, Agile, and Lean are a plus

KNOWLEDGE, SKILLS, AND ABILITIES:

• Develop strong and productive working relationships with others
• Form strong team bonds and enhance team performance
• Strong organizational and quality management skills with ability to handle multiple, competing tasks and priorities
• Cope with rapidly changing information in a fast-paced environment
• Proven communication, interpersonal, analytical, and organizational skills
• Proven ability to properly communicate with customers (in person and via phone) and manage expectations during a project
• Work both independently and as a member of the implementation and support team
• Manage multiple concurrent activities, all with fluctuating deadlines, by working with other departments, both internal and external
• Quickly identify and resolve issues
• Quickly understand complex concepts
• Excellent oral and written communication skills
• Excellent customer management skills
• Above average observational skills to collect data and validate information
• Outstanding analytical skills with the ability to critically evaluate the information gathered from multiple sources, reconcile conflicts, relate high-level information to details, and distinguish user requests from underlying business problems/needs.
• Effectively represent Jackson Healthcare/Care Logistics values and principles in decision-making and actions
• Support leadership and/or project management
• Excellent troubleshooting skills
• Excellent organizational and delivery skills
• Install, configure, and manage hardware and software in AWS and on-premises environments
• Provide specifications for system hardware and AWS service requirements
• Implement complex system solutions involving multiple technologies
• Control and implement complex system and application feature configurations
• Troubleshoot complex system and technical issues
• Read and understand system and application logs
• Proven ability to communicate and teach complex technical concepts to less technical resources
• Excellent communications and interpersonal skills, as well as analytical and problem-solving skills
• Excellent documentation skills

REQUIRED KNOWLEDGE

• Amazon Web Services (AWS) services such as EC2, RDS, Systems Manager, VPN, CloudWatch
• Monitoring systems such as AWS CloudWatch, Datadog, New Relic, SolarWinds, Dynatrace, etc.
• In-depth knowledge of Linux (Red Hat Operating System) concepts and operations in a production environment
• VMware, Web servers, DBMS, Reporting and analytic tools
• Project Management Methodologies
• Advanced PC knowledge including proficiency with MS Outlook, Word, Excel, and PowerPoint

DESIRED KNOWLEDGE

• Knowledge automating and configuring Amazon Web Services (AWS) such as EC2, RDS, VPN
• Understanding of high availability server environments
• Hardware and software installation techniques
• Healthcare Information Systems
• Enterprise reporting tools
• DevOps and Agile methodologies related to project delivery, operations, and support
• Ticketing systems such as JIRA and related incident management tools (such as OpsGenie)

TRAVEL REQUIREMENTS & WORKING CONDITIONS:

• 10-80% travel required
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
• The employee must frequently lift and/or move up to 50 pounds
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus

Lou-Rich is seeking a skilled and detail-oriented Assembler to join our team. As an Assembler, you will play a crucial role in our manufacturing process by accurately and efficiently assembling components to create finished products. You will be responsible for ensuring that the highest quality standards are met and that all products are assembled according to specifications. Your precision and attention to detail will contribute to the overall success and customer satisfaction of our organization.

About Innovance, Inc.

Innovance is the holding company for a family of four, 100% employee-owned, Minnesota-based manufacturing companies (Lou-Rich, ALMCO, Panels Plus, Mass Finishing). Our mission is to lead, nurture, and grow a team of industrial manufacturing companies committed to making our OEM customers products better.

About Lou-Rich

Lou-Rich is a fully integrated contract manufacturer specializing in complex projects. We provide precision machining, metal fabrication, assembly, and sourcing solutions to a variety of industries, including some of North Americas largest OEMs. Companies of all sizes from Fortune 500 companies to small, fast-growing operations trust Lou-Rich with their most vital and complex manufacturing projects.

Position Description:

Perform sub assembly and final assembly processes on a variety of mechanical and electrical assemblies. Will use calibrated equipment and machinery, engineering and simple drawings, schematics, as well as written and verbal instructions to perform basic assembly, mechanical, and electrical functions. Will also maintain documentation on work performed, match work procedures with ISO documents, and read and interpret sketches and/or blueprints to describe or identify non-conformance.

Essential Functions:

Utilize hand tools, power tools and hardware to assemble and wire standard and engineered products to customer specifications and quality standards with the aid of supervision or trainers.

Apply acquired trade skills such as electrical, mechanical and plumbing to complete assembly process.

Follow ISO procedures.

Perform job set-up by obtaining necessary/required parts, drawings, and schematics. Check for correctness of parts by referencing the bill of material. Read and interpret drawings and schematics.

Communicate with engineers, designers, and technicians to resolve assembly discrepancies.

Perform ongoing inspection of product during assembly and wiring process and prior to products shipment.

Lift and position assemblies. Operate overhead hoist/crane to assist with the lifting and control of moving/positioning of assembly.

Maintain a clean, safe, and orderly work area.

Set-up and performs Assembly Department operations with minimum supervision.

Familiar with mechanical and electromechanical components.

Thorough understanding of part prints (tolerances, symbols, etc.).

Perform checks for quality of parts and make adjustments as required.

Perform other duties as assigned.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

High School Diploma or equivalent

Entry level or 1-2 years of assembly experience

Knowledge of ISO

Familiar with mechanical and electromechanical components

Able to read and interpret routings, bills of material, assembly drawings, work instructions and notes

Manual dexterity

Ability to work in a team setting

A positive can-do attitude

Strong motivation and communication skills

Problem solving skills

Refuse to be satisfied with average performance

Other duties as assigned

Lou-Rich Training Requirements:

Applicable training will be completed by following the syllabi (Human Resources, Safety, IFS Time clock, IFS - Navigation, ISO, Inspection Hand Tools, Inspection Forms, CMM, and Technical) for each new hire and that will be verified by the Employee Orientation & Job Qualification form within the first 60 days of employment. Additional applicable training will be completed by following the individuals assigned department training matrix, Paint Line (F4400-355).

Follow training syllabus (Technical from above list). Effectiveness of training guidelines will be determined by employee knowledge and demonstration of learned concepts. Additional training after the first several weeks of on-the-job training will be determined by the Supervisor in preparation to operate on their own as needed. Any follow-up training will be evaluated and provided at the 60-day review or as deemed necessary for the position.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands and fingers, and talk and hear.

Work Environment:

The work environment characteristics described here are representative of those and employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Americans with Disabilities Act:

If you are a qualified individual with a disability, you have a right to request that the Authority make reasonable accommodations in order to help you accomplish your work, which must still be performed in all essential functions.

PI2ee4d3ebc90d-26289-39075568

Company

3DDx is a digital dental lab that provides guided surgery solutions such as Dental Implant Implant Treatment Planning, Surgical Guides, Full Arch Restorations, and Orthodontic Aligners to dental professionals all over the world. We are looking for an energetic self-starter to join our restorations team.

Job Summary

Fabrication of dentures for full arch implant-supported restorations.

Qualifications

- 3 to 5 years of experience working in a dental lab setting in the Crown and Bridge Department.

- Fabrication and repairing of dental prostheses specifically crowns, bridges, and implants restorations by stacking porcelain or finishing pressed porcelain on metal, zirconia and eMax copings.

- Knowledge of dental implants from single implant restorations to full arch cases.

- Excellent knowledge of different crown and bridge materials and the process to fabricate (PMMA, PFM, PFZ, Zirconia, Hybrid Ceramics, Composites).

- Thorough understanding of dental anatomy and occlusion.

- Zirconia/Emax material experience - both anterior and posterior.

- Able to pour, articulate and mount stone models (implant impression) is a must.

- Ability to create verification jigs, base plates, and occlusion rims, for implant restorations.

- Experience with milling CAM Software / Hardware is a plus.

Hours

Part time, 20-25 hours per week, flexible hours (weekdays, evenings, and weekends are all fine)

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero's Carlsbad, CA office, we are looking for a Senior Product Development Engineer to join our mission-driven team driving innovative solutions for patients and customers. In this role you will champion the design, development, and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence!

Responsibilities

• Act as a technical lead, increasing the rigor of technical product development, with project oversight of products, accessories, and cross-functional initiatives.
• Manage product development deliverables of high complexity through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5).
• Track technical risk and provide engineering guidance.
• Provide feedback and mentorship to junior engineers.
• Lead the development team through technical risk retirement. Guide the team on technical risks through step-by-step simplification to discover root cause.
• Create, review, and release documents according to Gilero's QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements.
• Inform project managers and business development on technical projects variables in order to build accurate project budgets that include feasibility, prototyping, verification and validation.
• Act as project manager for smaller, technically oriented projects.

Skills/Qualifications:

• Able to work in the office 4 days a week
• BS in Engineering or equivalent technical degree
• 5+ years of product development experience in medical device, combination product or similar space preferred.
• Skilled at transforming complex situations into well-defined project deliverables
• Able to lead team to achieve difficult goals through step-by-step simplification
• Able to convert complex questions into tasks to further drive simplification and clarification.
• Understanding of good GDP
• Understand the Phase Gate System
• Have deep ISO 14971, 13485 and CFR 21 Knowledge base; Experience with ISO 10993 a plus.
• Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs.
• Create/draft clinically relevant User Requirements with minimal oversight
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing.
• Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Prepare documentation to support design history files and regulatory submissions
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• Support chartering and maintaining project objectives and milestones.
• Develop testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.
• Lead product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
• Write and execute protocols for design verification and validation
• Lead test method development and validation, have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Lead investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
• Investigate, evaluate, and research competitive devices and product materials/designs
• Understanding of Pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc).

Personal Attributes:

Meets Gilero Core Values:

Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors

Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind

Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems

Excellence - delivering exceptional products and services with passion and pride

• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customers
• Follows established policies and procedures, while contributing to continuous improvements
• Excellent communication skills (oral and written)

Eligibility To Work

Candidates must be legally eligible to work in the US without requiring current or future sponsorship. Gilero does not offer sponsorship for employment authorizations (work visas).

We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

Position Summary

Our client is building a modern, cloud-native platform that powers connected, data-driven manufacturing operations. Their technology sits at the center of increasingly automated factories, integrating equipment, software systems, and real-time production data into a scalable SaaS platform used by global manufacturers.

To support rapid growth and platform scale, they are seeking a Senior Cloud Operations Engineer to own the reliability, performance, and operational excellence of their cloud infrastructure. This is a highly impactful role responsible for ensuring the platform remains highly available, secure, and scalable as adoption continues to grow.

This position is ideal for engineers who thrive in modern cloud environments, enjoy solving complex reliability challenges, and prefer automating everything possible. The right person will combine deep technical expertise with strong operational discipline, helping build a world-class cloud platform supporting real industrial environments.

Key Responsibilities

Cloud Operations & Reliability

• Maintain and optimize production, staging, and development environments running in Kubernetes on AWS

• Implement and manage monitoring, logging, alerting, and observability frameworks

• Lead incident response efforts and drive post-incident reviews focused on continuous improvement

• Own backup, disaster recovery, and business continuity processes

• Perform system capacity planning and performance tuning

Automation & Infrastructure Management

• Build and maintain Infrastructure-as-Code using tools such as Terraform or Pulumi

• Automate provisioning, configuration management, and environment lifecycle processes

• Identify and eliminate operational inefficiencies through automation

• Manage secrets, environment configuration, and version control across infrastructure environments

Security & Compliance

• Implement and maintain least-privilege access models and cloud security guardrails

• Support vulnerability management, patching workflows, and dependency maintenance

• Assist with compliance readiness efforts including SOC 2, ISO 27001, or similar frameworks

• Ensure proper logging, retention, and audit practices across cloud environments

FinOps / Cost Optimization

• Monitor and optimize cloud spend across services and environments

• Implement tagging standards, budget alerts, and cost visibility frameworks

• Recommend architectural improvements to balance performance and cost efficiency

Collaboration & Leadership

• Partner closely with engineering teams to improve reliability, deployment pipelines, and system architecture

• Mentor engineers on operational best practices and cloud platform management

• Develop runbooks, documentation, and operational standards

• Champion reliability engineering principles, operational maturity, and risk reduction practices

Technical Environment

Candidates should be comfortable working in modern cloud-native environments and familiar with:

• Kubernetes clusters, autoscaling, Helm charts, and service mesh concepts

• AWS cloud services including compute, networking, storage, and cost management

• Infrastructure-as-Code frameworks such as Terraform

• Observability platforms such as Datadog, CloudWatch, Prometheus, or New Relic

• CI/CD tools such as GitHub Actions, Bitbucket Pipelines, or Bamboo

• Linux systems administration and troubleshooting

• SRE practices including SLIs, SLOs, MTTR, RTO/RPO, and incident management