Job Summary
The Mechanical Engineer will support the design, evaluation, qualification, and lifecycle management of nonchemical product components including plastics, plastic tubes, glass vials, glass ampules, rubber stoppers, aluminum crimps, labels, cardboard packaging, and applicator tips. This role involves handson, onsite support for manufacturing and suppliers, as well as datadriven analysis and design control activities to ensure robust, compliant, and highquality components over the full product lifecycle.
Area Of Responsibility
Product & Component Support
Provide engineering support for existing components, including onsite troubleshooting and technical assistance at internal manufacturing areas and supplier facilities.
Conduct detailed investigations and rootcause 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 nonchemical 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 highvolume 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 onsite 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 costeffectiveness.
Project Management & Collaboration
Participate in crossfunctional project teams, providing engineering expertise for planning, scheduling, estimation, and execution.
Manage componentrelated 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 componentrelated 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
4-6 years of experience in the pharmaceutical, medical device industry and/or biomedical field preferred.
Previous experience with MSTG preferred.
Familiar with QSR / GMP regulations.
Experience with Microsoft Office Tools required, CAD experience preferred.
The presently-anticipated base compensation pay range for this position is $97,000 to $107,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
