Component Development Engineer – NPD, Lifecycle Change & Design Validation

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

Location :Cincinnati BMC, OH

JD :

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

Pre-Screening Questionnaire

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

• Are you comfortable following detailed written procedures and protocols?

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

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

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

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

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."

Essential Skills: Component Dev Engineer

Desirable Skills:

Keyword:

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

Experience Required: 6-8

Note : Interested candidates share your resumes to sai1@vmcsofttech.com or reach me out 4804076917