Senior Medical Device Engineer – Sustaining & New Projects

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 103,000 - 125,000; Full time

Job summary

Sun Pharmaceuticals seeks an experienced mechanical/electromechanical engineer to provide sustaining and new project support for medical products. You will investigate, analyze root causes, and ensure documentation aligns with regulatory standards.

Responsibilities include design controls, risk analyses, and collaboration with suppliers and cross-functional teams. The role emphasizes compliance with QSR/GMP and international standards, plus hands-on tests, documentation, and potential IP

Qualifications

• 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

Responsibilities

• Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements
• Prepare and maintain all necessary product documentation including product specifications, bills of material, hazard/risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers
• Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate
• Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects
• Ensure that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc.)
• Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements
• Contribute to new and supplemental regulatory submissions
• Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required
• Contribute ideas or generate Intellectual Property submissions
• Other duties as assigned
• Performs all principle duties that affect the quality of products and services provided by DUSA Pharmaceuticals, Inc. within the guidelines of 21 CFR 210/211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business.

Skills

Medical device industry experience

QSR / GMP regulations

Microsoft Office

Education

BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience

Tools

SolidWorks

Microsoft Office

Job description

Sun Pharmaceuticals seeks an experienced mechanical/electromechanical engineer to provide sustaining and new project support for medical products. You will investigate, analyze root causes, and ensure documentation aligns with regulatory standards.

Responsibilities include design controls, risk analyses, and collaboration with suppliers and cross-functional teams. The role emphasizes compliance with QSR/GMP and international standards, plus hands-on tests, documentation, and potential IP