LanceSoft
LanceSoft

60 Lancesoft Senior Reliability Engineer Jobs Hiring Near You

Reliability Engineer II - Exempt

Warsaw, IN

$99K - $124K/yr

We are seeking a skilled Reliability Engineer II to play a pivotal role in ensuring the reliability and compliance of our cutting-edge projects. Must Have * 1-3 years of experience in the Medical ...

Ability to develop test specifications, validate conformance, and ensure long-term reliability ... LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to ...

Senior Data Engineer

$108K - $147K/yr

LanceSoft, Inc. is seeking a Senior Data Engineer to support their data engineering initiatives ... reliability • Conduct test coverage analysis and ensure adequate validation across all data ...

Quality Engineer III

North Haven, CT · On-site

$71K - $92K/yr

Company Description Energy, it defines LanceSoft. Consider our unique 'keep apace' operational ... sigma), reliability engineering, component specification / approval, process evaluation and ...

Manager is looking for a senior BE with full-stack profile engineer: React+TS, Kotlin, AWS. Employee Benefits : At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more ...

Manager is looking for a senior BE with full-stack profile engineer: React+TS, Kotlin, AWS. Employee Benefits : At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more ...

Manager is looking for a senior BE with full-stack profile engineer: React+TS, Kotlin, AWS. Employee Benefits : At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more ...

Devops Engineer

Sylmar, CA · On-site

$53.50 - $73.50/hr

LanceSoft, Inc. is seeking a Devops Engineer to design, implement, and maintain CI/CD pipelines for ... reliability. Responsibilities : • Design, implement, and maintain CI/CD pipelines for mobile ...

This job is with Encode, Inc a fully owned subsidiary of Lancesoft As a member of the GSCCE team ... quality, reliability, and functionality Advises on the set up and configuration of test ...

Level 3 (senior): 5-7 years Location: Montreal (Day 1 onboarding onsite / in office presence 3x ... Proficiency in DevOps, CI/CD, observability (OpenTelemetry, Prometheus, Grafana), and SRE-inspired ...

As a Senior Development Contract Engineer, you serve as a specialist in the engineering team that ... At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are ...

Development Engineer

Minneapolis, MN · On-site

$61.53 - $92.30/hr

As a Senior Development Contract Engineer, you serve as a specialist in the engineering team that ... At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are ...

This job is with Encode, Inc a fully owned subsidiary of Lancesoft As a member of the GSCCE team ... quality, reliability, and functionality Advises on the set up and configuration of test ...

Level 3 (senior): 5-7 years Location: Montreal (Day 1 onboarding onsite / in office presence 3x ... Proficiency in DevOps, CI/CD, observability (OpenTelemetry, Prometheus, Grafana), and SRE-inspired ...

Devops Engineer

Sylmar, CA

$53.50 - $73.50/hr

Automate testing, deployment, and monitoring processes to improve efficiency and reliability ... EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity ...

Level 3 (senior): 5-7 years Location: Montreal (Day 1 onboarding onsite / in office presence 3x ... Proficiency in DevOps, CI/CD, observability (OpenTelemetry, Prometheus, Grafana), and SRE-inspired ...

Devops Engineer

Sylmar, CA

$53.50 - $73.50/hr

Automate testing, deployment, and monitoring processes to improve efficiency and reliability ... EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity ...

Showing results 41-60

Reliability Engineer II - Exempt

Reliability Engineer II - Exempt

LanceSoft

Warsaw, IN

$99K - $124K/yr

Full-time

Posted 9 days ago


Job description

Join our dynamic team in Warsaw, IN, where innovation meets precision in the heart of the medical device industry. We are seeking a skilled Reliability Engineer II to play a pivotal role in ensuring the reliability and compliance of our cutting-edge projects.

Must Have
  • 1-3 years of experience in the Medical Device industry.
  • Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
  • Knowledge of standards: ISO 13485, ISO 14971, IEC 60601.
  • Proficiency in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
  • Strong written and verbal communication skills.
  • Ability to work cooperatively as part of a cross-functional team.
  • 4 years of engineering experience in a medical device manufacturing environment.
  • Ability to collaborate effectively with a wide range of stakeholders and internal customers.
Nice to Have
  • 5 years in validation of automated cells, Installation, Operational, and Performance Qualifications.
  • Shot peen experience – Certified in shot peening, either level 1 or level 2.
Top 3 Technical Skills Required
  • Ability to write validation master plans, Installation, operational, and performance qualification plans and reports with limited guidance.
  • Understanding of software validation.
  • Understanding of automation and how these systems get validated.
Education Required

Engineering Degree (BS)

Responsibilities

Responsibilities will include leading and executing validation activities associated with the installation, qualification, and lifecycle management of a new automated shot peening system, in alignment with applicable medical device regulatory requirements and industry standards, including FDA 21 CFR Part 820, ISO 13485:2016, and GAMP 5 guidance for automated systems.

This scope will encompass the development and approval of a comprehensive Validation Master Plan (VMP), as well as the generation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to ensure the equipment consistently operates within defined specifications and meets intended use requirements. A risk-based validation approach will be applied in accordance with ISO 14971 principles to ensure appropriate rigor and traceability.

The primary focus will be the validation of the automated shot peening system; however, responsibilities will also include oversight of requalification and validation activities required for the restart of a fully automated rod cell. This system integrates machining, bending, inspection, and closed-loop autocorrection capabilities, requiring thorough assessment of process capability, software/controls validation considerations, and data integrity compliance.

Additionally, the project will involve coordination of facility and equipment modifications necessary to support the new installation. This includes the relocation or reconfiguration of adjacent equipment, as well as validation-impact assessments and qualification support for critical utilities such as compressed air systems and RO/DI water systems, ensuring they meet applicable process and quality requirements. All activities will be planned and executed to minimize disruption to ongoing manufacturing operations while maintaining compliance with change control and validation procedures.

Upon successful installation and validation of all impacted systems, the project will transition into a scale-up phase involving the introduction and qualification of additional rod product lines into the facility, ensuring continued compliance with process validation and production readiness requirements.


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About LanceSoft

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Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

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