Component Development Engineer

Job Description – Component Development Engineer

General Information

• Location: Cincinnati, BMC, Ohio

• Duration: 6 months

• Experience Required: 6–8 years

• Role: Component Development Engineer / Tissue Laboratory Technician

• Work Environment: Regulated laboratory, engineering, and product development environment

Must-Have Technical/Functional Skills

• Tissue preparation and handling.

• Laboratory setup and teardown procedures.

• Good Documentation Practices (GDP).

• Equipment setup, operation, and verification.

• Microsoft Office proficiency, including Excel, Word, and Outlook.

• Basic data recording, analysis, and reporting.

• New Product Development (NPD) methodology and management.

• Medical Device Development (MDD) risk management.

• Component development and engineering change management.

• Design verification and validation support.

• Quality systems and regulatory compliance.

Roles and Responsibilities

Laboratory Operations and Tissue Handling

• Read and understand tissue laboratory protocols and procedures for individual and team execution.

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

• Follow written procedures to safely operate laboratory equipment.

• Become familiar with tissue testing methods performed in the laboratory.

• Perform tissue measurements, gluing, holding, and related preparation activities.

• Set up laboratory equipment, fixtures, and software, and perform verification checks.

• Configure laboratory spaces for different testing requirements.

• Cross-train in mechanical and materials laboratories to expand technical capabilities.

• Support preparation of complex data sheets and written test reports.

• Perform additional duties as assigned.

Documentation and Testing

• Record test data using Good Documentation Practices in handwritten or electronic formats.

• Maintain accurate, complete, and traceable laboratory records.

• Support test planning, test execution, data review, and technical documentation.

• Ensure laboratory activities comply with established procedures and quality requirements.

Component Development and Engineering

• Lead multiple high-priority lifecycle change projects from concept through implementation.

• Develop and manage 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, Design for Manufacturing (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 design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.

• Review engineering drawings, specifications, Geometric Dimensioning and Tolerancing (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 to stakeholders and senior leadership.

• Demonstrate ownership, urgency, accountability, and the ability to influence without direct authority.

Essential Skills

• Component Development Engineering.

• Tissue preparation and handling.

• Regulated laboratory operations.

• Laboratory equipment setup and verification.

• Good Documentation Practices (GDP).

• Test data recording and reporting.

• New Product Development (NPD) methodology and management.

• Medical Device Development (MDD) risk management.

• Design verification and validation.

• Engineering change management.

• Design for Manufacturing (DFM).

• Root cause analysis and technical problem-solving.

• IQ/OQ/PQ process validation.

• Engineering drawings, GD&T, and tolerance analysis.

• Cross-functional project coordination.

• Quality systems and regulatory compliance.

Generic Managerial and Behavioral Skills

• 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 changing deadlines and priorities.

• Self-starter who can work independently and collaboratively.

• Strong ownership, accountability, and urgency.

• Effective stakeholder and supplier management.

• Ability to influence cross-functional teams without direct authority.

Preferred Keywords for Resume Search

• Tissue Laboratory Technician.

• Tissue Tech I / II.

• Regulated Laboratory Environment.

• Tissue Preparation.

• Laboratory Equipment Setup.

• Good Documentation Practices.

• Data Recording and Reporting.

• Component Development Engineer.

• New Product Development (NPD).

• Medical Device Development Risk Management.

• Design Verification and Validation (V&V).

• Engineering Change Management.

• Design for Manufacturing (DFM).

• IQ/OQ/PQ Validation.

• GD&T and Tolerance Analysis.

• Root Cause Analysis.

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 laboratory 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?

• Do you have experience in component development or new product development?

• Have you supported design verification, validation, or manufacturing process validation?

• Do you have experience with engineering change management and risk management?

• Have you worked with suppliers on component qualification, DFM, or tooling readiness?