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Company

Original Job Post

Johnson & Johnson · 3 days ago

Life Cycle Management, Staff Engineer

Irving, TX

Full-time

Onsite

Mid Level

4+ years exp

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Health CareMedical Device

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Responsible for presenting business-related issues or opportunities to the next management level.

Comply with all Federal, State, local, and Company regulations, policies, and procedures.

Identify potential risks and challenges associated with product life cycle activities and develop mitigation strategies proactively.

Successfully execute product life cycle projects with mid/high complexity under minimal mentorship.

Interact with R&D, Quality, and Regulatory for life cycle and design change projects.

Follow Company guidelines related to Health, Safety, and Environmental practices.

Demonstrate understanding and application of core GMP fundamentals.

Ensure product life cycle activities adhere to regulatory requirements, industry standards, and company policies.

Identify opportunities for process optimization, cost reduction, and quality improvement.

Implement improvements and standard methodologies to maximize efficiency and effectiveness.

Qualification

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OperationsNew product developmentManufacturingSupply chainLogisticsProject managementMedical device industryRisk managementLabeling regulationsRegulatory complianceMS OfficeStatistical analysis softwareLeadershipProblem-solvingCommunicationFlexibilityHealthcare Quality SystemsChange ControlSix SigmaAdaptability

Required

A minimum of a Bachelor's degree in Engineering or Manufacturing Operations is required.

A minimum of 4 years’ experience in Operations within New Product Development, Quality, and/or Manufacturing, Supply, and Logistics with significant project and leadership skills is required.

Experience in the Medical Device or Diagnostics industry

Ability to work effectively in a fast-paced, multifaceted environment and lead multiple projects simultaneously.

Must have proven successful completion of developing and leading several technical and/or business challenges. Demonstrated ability to interact and lead, as applicable, with cross-functional/multi-disciplined teams is required.

Proven knowledge of risk management principles and their application to labeling, including hazard identification, risk assessment, risk control measures, and risk communication strategies.

Ability to interpret and apply labeling requirements for medical devices, including content, format, language, symbols, and placement. Familiarity with labeling standards.

Familiarity with regulatory requirements and standards relevant to product life cycle management.

Proficiency with MS Office and Statistical Analysis Software is required.

Demonstrated track record of Project Management is required.

Ability to prioritize multiple commitments and technical problem-solving duties.

Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.

Must have advanced proficiency in written and verbal communication.

Preferred

Experience in a New Product Development project is preferred.

Demonstrated understanding of the healthcare-supervised industry Quality Systems and Change Control procedures is preferred.

Six Sigma/Process Excellence and/or Design Excellence experience is preferred.

Benefits

Health Insurance

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10,001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson 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

Trends of Total Sponsorships

2023 (43)

2022 (55)

2021 (40)

2020 (30)