Component Development Engineer - NPD, Lifecycle Change & Design Validation

Job Description

Job Title : Component Development Engineer – NPD, Lifecycle Change & Design Validation

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Location :Cincinnati BMC, OH

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JD :

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Must Have Technical/Functional Skills

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• Tissue preparation and handling

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• Lab setup and teardown procedures

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• Good Documentation Practices (GDP)

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• Equipment setup and verification

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• MS Office proficiency (Excel, Word, Outlook)

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• Basic data recording and reporting

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Roles & Responsibilities

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• Read and understand Tissue Lab protocols and procedures for individual and team execution

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• Perform daily lab activities including setup, tissue receipt, tissue preparation, equipment setup, and lab closure

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• Read and follow procedures to safely operate lab equipment

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• Become familiar with various tissue testing methods performed in the lab

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• Perform tissue measurement, proper gluing, holding, and related responsibilities

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• Record test data using good documentation practices in handwritten or electronic formats

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• Cross-train in other lab areas such as mechanical and materials labs to broaden skill sets

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• Set up lab equipment including fixtures and software and perform verification checks

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• Configure lab spaces for different types of testing requirements

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• Support preparation of complex data sheets and written test reports • Perform additional duties as assigned

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Generic Managerial Skills, If any

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• Strong attention to detail and compliance focus

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• Ability to multitask in a fast-paced, regulated environment

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• Clear written and verbal communication skills

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• Customer-focused mindset

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• Ability to adapt to shifting deadlines and priorities

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• Self-starter with ability to work independently and within a team

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Key Words to search in Resume

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• Tissue Laboratory Technician

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• Tissue Tech I / II

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• Regulated Laboratory Environment

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• Tissue Preparation

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• Lab Equipment Setup

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• Good Documentation Practices

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• Data Recording & Reporting

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Pre-Screening Questionnaire

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• Do you have experience working in a regulated laboratory environment?

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• Are you comfortable following detailed written procedures and protocols?

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• Have you handled biological or tissue samples in a lab setting?

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• Do you have experience documenting test data manually or electronically?

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• Are you able to adapt to shifting priorities and deadlines while maintaining accuracy?

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• Are you comfortable working independently as well as part of a team?

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Role Descriptions: "Lead multiple high-priority lifecycle change projects from concept through implementation.Drive project plans| timelines| risk mitigation strategies| and implementation readiness.Coordinate cross-functional teams across Engineering| Quality| Regulatory| Manufacturing| Supply Chain| Procurement| Operations| and external suppliers.Serve as the technical interface with suppliers for component development| DFM reviews| tooling readiness| process capability| and component qualification.Support design verification and validation activities| including test planning| execution| data review| and technical documentation.Partner with manufacturing sites on process validation activities| including IQ/OQ/PQ| pilot builds| validation builds| and production launch readiness.Apply strong knowledge of design controls| engineering change management| risk management| quality system requirements| and regulatory expectations.Review engineering drawings| specifications| GD&T requirements| tolerance analyses| and component acceptance criteria.Drive root cause analysis| technical problem solving| and timely closure of project issues.Communicate project status| risks| decisions| and recommendations clearly to stakeholders and senior leadership.Demonstrate strong ownership| urgency| accountability| and ability to influence without direct authority."

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Essential Skills: Component Dev Engineer

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Desirable Skills:

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Keyword:

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Skills: EIS : New Product Development (NPD) Methodology and Management~EIS : MDD Risk Management

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Experience Required: 6-8

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Note : Interested candidates share your resumes to View email address on ziprecruiter.com or reach me out View phone number on ziprecruiter.com