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