Product & Components Engineer
Summary
Supports design, testing, validation, and lifecycle management of non-chemical product components, with on-site troubleshooting at manufacturing and supplier facilities. Requires SolidWorks and Microsoft Office, QSR/GMP familiarity, and 7-10 years in medical device or biomedical fields preferred; up to 10% travel.
Highlights
- Work Arrangement
- On-Site
- Experience
- 7-10 years in medical device and/or biomedical field preferred
- Education
- BS in Mechanical Engineering preferred; associate degree or relevant experience considered
- Certifications
- Familiarity with QSR/GMP regulations
- Travel Required
- Up to 10%
- Physical Requirements
- Lift and move boxes/equipment up to 70 lbs; stand, walk, sit, climb, kneel, crouch, crawl, and operate hand trucks
- Equipment Provided
- Microsoft Office tools and SolidWorks required
- Type
- Full-Time
Job description
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
Design Control & Documentation
Testing, Validation & Data Analysis
Manufacturing & Supplier Support
Project Management & Collaboration
Training, Leadership & Innovation
Other Responsibilities
Work Conditions:
Physical Requirements:
Travel Estimate
Up to 10%
Education and Job Qualification
Experience
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