Senior Product & Component Engineer – Medical Devices

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc (USA) seeks a Product & Component Engineer to support design, evaluation, qualification, and lifecycle management of non-chemical product components such as plastics, vials, stoppers, labels, and packaging. On-site support for manufacturing and suppliers, with data-driven analysis to ensure robust components throughout the lifecycle.

The role emphasizes on-site testing, documentation, CAPA implementation, and collaboration across teams to maintain quality and

Qualifications

• BS in mechanical engineering required; related experience considered.
• Experience with design controls and GMP/QSR advisable.
• Experience with component testing and mechanical validation.

Responsibilities

• Provide engineering support for existing components at manufacturing and supplier sites.
• Conduct root-cause analyses and implement CAPAs for component issues.
• Develop and maintain component specifications, drawings, BOMs, and risk analyses.
• Plan and execute mechanical testing to verify performance and durability.
• Review validation protocols and reports for components and packaging.
• Mentor technicians and coordinate cross-functional project work.
• Ensure calibration and traceability of equipment used in component production.

Skills

Root cause analysis

CAPA

Data analysis

On-site troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Associate's degree in Mechanical Engineering or relevant experience

Tools

SolidWorks

Microsoft Office

Job description

Sun Pharmaceutical Industries, Inc (USA) seeks a Product & Component Engineer to support design, evaluation, qualification, and lifecycle management of non-chemical product components such as plastics, vials, stoppers, labels, and packaging. On-site support for manufacturing and suppliers, with data-driven analysis to ensure robust components throughout the lifecycle.

The role emphasizes on-site testing, documentation, CAPA implementation, and collaboration across teams to maintain quality and