Pay Rate Range: $ 24.24 - 26.51/hr.
Job Description:
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.
Must Have Technical/Functional Skills
• Tissue preparation and handling
• Lab setup and teardown procedures
• Good Documentation Practices (GDP)
• Equipment setup and verification
• MS Office proficiency (Excel, Word, Outlook)
• Basic data recording and reporting
Roles & Responsibilities
• Read and understand Tissue Lab protocols and procedures for individual and team execution
• Perform daily lab activities including setup, tissue receipt, tissue preparation, equipment setup, and lab closure
• Read and follow procedures to safely operate lab equipment
• Become familiar with various tissue testing methods performed in the lab
• Perform tissue measurement, proper gluing, holding, and related responsibilities
• Record test data using good documentation practices in handwritten or electronic formats
• Cross-train in other lab areas such as mechanical and materials labs to broaden skill sets
• Set up lab equipment including fixtures and software and perform verification checks
• Configure lab spaces for different types of testing requirements
• Support preparation of complex data sheets and written test reports • Perform additional duties as assigned
Generic Managerial Skills, If any
• Strong attention to detail and compliance focus
• Ability to multitask in a fast-paced, regulated environment
• Clear written and verbal communication skills
• Customer-focused mindset
• Ability to adapt to shifting deadlines and priorities
• Self-starter with ability to work independently and within a team
Key Words to search in Resume
• Tissue Laboratory Technician
• Tissue Tech I / II
• Regulated Laboratory Environment
• Tissue Preparation
• Lab Equipment Setup
• Good Documentation Practices
• Data Recording & Reporting
Essential Skills: Component Dev Engineer
Skills: EIS : New Product Development (NPD) Methodology and Management~EIS : MDD Risk Management
Experience Required: 6-8 years