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
- 01Provide engineering support for existing components, including on‑site troubleshooting and technical assistance at internal manufacturing areas and supplier facilities.
- 02Conduct detailed investigations and root‑cause analyses for issues involving any component (e.g., plastic tubes, glass ampules, cardboard packaging).
- 03Implement corrective and preventive actions (CAPA) to resolve component issues and enhance product robustness.
- 04Support customer and product requirements by evaluating component performance and suitability for use.
Design Control & Documentation
- 05Develop and maintain component specifications, drawings, bills of materials, hazard/risk analyses, and mechanical test procedures.
- 06Create and update packaging and labeling specifications for tubes, ampules, cardboard packaging, stoppers, crimps, and applicator tips in accordance with regulatory and industry requirements.
- 07Support new and supplemental regulatory submissions related to non‑chemical and packaging components.
Testing, Validation & Data Analysis
- 08Plan and execute mechanical and functional testing of components to verify performance, durability, and reliability.
- 09Conduct CpK and process capability analysis for component manufacturing processes, particularly for high‑volume components such as plastic tubes, glass ampules, and stoppers.
- 10Review and approve validation protocols and reports for components, packaging systems, and associated manufacturing equipment.
Manufacturing & Supplier Support
- 11Provide 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.
- 12Ensure equipment and facilities used for component production or inspection are maintained, calibrated, and properly documented.
- 13Review production records, component batch documentation, and supplier data for accuracy and compliance.
- 14Analyze manufacturing processes and implement engineering improvements to enhance consistency, yield, and cost‑effectiveness.
Project Management & Collaboration
- 15Participate in cross‑functional project teams, providing engineering expertise for planning, scheduling, estimation, and execution.
- 16Manage component‑related engineering projects to ensure delivery on time, within budget, and in alignment with design requirements.
- 17Evaluate proposed changes to component designs, materials, suppliers, or manufacturing processes.
Training, Leadership & Innovation
- 18Train and mentor technicians, manufacturing personnel, and suppliers on component specifications, handling, and quality requirements.
- 19Generate and support intellectual property submissions through innovative design approaches.
- 20Provide training and technical support for component‑related processes and documentation.
Other Responsibilities
- 21Maintain compliant, organized, and safe working environments with complete records of maintenance, calibration, and facility activities.
- 22Perform additional engineering duties as assigned.
Work Conditions
- 23Office
- 24Lab
- 25Manufacturing area/clean room area
- 26Maintenance Shop
- 27Exposure to noise, hot and cold, outside elements, some radiation
Physical Requirements
- 28Stand, 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
- 29Close, distance and peripheral vision; depth perception, ability to focus
- 30Ability to operate production equipment and hand tools
- 31Operate hand truck
- 32Operate computer/office equipment
- 33Wear proper lab gowning and safety shoes
- 34Lifting and moving of heavy boxes/equipment up to 70 lbs.
Travel Estimate
Up to 10%
Education and Job Qualification
- 35BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
- 36Ability to interpret and resolve technical and design issues required
Experience
- 377-10 years of experience in the medical device industry and/or biomedical field preferred
- 38Familiar with QSR / GMP regulations
- 39Experience with Microsoft Office Tools and Solid Works required
- 40Pharmaceutical industry experience a plus
Estados Unidos
