Product & Components Engineer

Job Summary

The Product & Component Engineer will support the design, evaluation, qualification, and lifecycle management of non-chemical product components including plastics, plastic tubes, glass vials, glass ampules, rubber stoppers, aluminum crimps, labels, cardboard packaging, and applicator tips. This role involves hands-on, on-site support for manufacturing and suppliers, as well as data-driven analysis and design control activities to ensure robust, compliant, and high-quality components over the full product lifecycle.

Area Of Responsibility

Product & Component Support

• Provide engineering support for existing components, including on-site troubleshooting and technical assistance at internal manufacturing areas and supplier facilities.
• Conduct detailed investigations and root-cause analyses for issues involving any component (e.g., plastic tubes, glass ampules, cardboard packaging).
• Implement corrective and preventive actions (CAPA) to resolve component issues and enhance product robustness.
• Support customer and product requirements by evaluating component performance and suitability for use.

Design Control & Documentation

• Develop and maintain component specifications, drawings, bills of materials, hazard/risk analyses, and mechanical test procedures.
• Create and update packaging and labeling specifications for tubes, ampules, cardboard packaging, stoppers, crimps, and applicator tips in accordance with regulatory and industry requirements.
• Support new and supplemental regulatory submissions related to non-chemical and packaging components.

Testing, Validation & Data Analysis

• Plan and execute mechanical and functional testing of components to verify performance, durability, and reliability.
• Conduct CpK and process capability analysis for component manufacturing processes, particularly for high-volume components such as plastic tubes, glass ampules, and stoppers.
• Review and approve validation protocols and reports for components, packaging systems, and associated manufacturing equipment.

Manufacturing & Supplier Support

• Provide on-site technical support at manufacturing and contract manufacturer locations to address issues with components such as cardboard packaging integrity, ampule quality, or tube assembly issues.
• Ensure equipment and facilities used for component production or inspection are maintained, calibrated, and properly documented.
• Review production records, component batch documentation, and supplier data for accuracy and compliance.
• Analyze manufacturing processes and implement engineering improvements to enhance consistency, yield, and cost-effectiveness.

Project Management & Collaboration

• Participate in cross-functional project teams, providing engineering expertise for planning, scheduling, estimation, and execution.
• Manage component-related engineering projects to ensure delivery on time, within budget, and in alignment with design requirements.
• Evaluate proposed changes to component designs, materials, suppliers, or manufacturing processes.

Training, Leadership & Innovation

• Train and mentor technicians, manufacturing personnel, and suppliers on component specifications, handling, and quality requirements.
• Generate and support intellectual property submissions through innovative design approaches.
• Provide training and technical support for component-related processes and documentation.

Other Responsibilities

• Maintain compliant, organized, and safe working environments with complete records of maintenance, calibration, and facility activities.
• Perform additional engineering duties as assigned.

Work Conditions:

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell
• Close, distance and peripheral vision; depth perception, ability to focus
• Ability to operate production equipment and hand tools
• Operate hand truck
• Operate computer/office equipment
• Wear proper lab gowning and safety shoes
• Lifting and moving of heavy boxes/equipment up to 70 lbs.

Travel Estimate

Up to 10%

Education and Job Qualification

• BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
• Ability to interpret and resolve technical and design issues required

Experience

• 7-10 years of experience in the medical device industry and/or biomedical field preferred
• Familiar with QSR / GMP regulations
• Experience with Microsoft Office Tools and Solid Works required
• Pharmaceutical industry experience a plus