Senior Medical Device Engineer — Sustaining & Innovation

SUN PHARMA; Billerica (MA); On-site; USD 103,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

401(k) savings plan

Paid time off

Employee assistance program

Job summary

Sun Pharma in the United States is seeking a Mechanical Engineer to provide sustaining engineering support for existing medical products as well as new projects.

BS in Mechanical Engineering preferred; 7 years of medical device experience; proficiency with SolidWorks and MS Office; familiarity with QSR/GMP; ability to interpret technical issues and contribute to design controls, risk analysis, and regulatory submissions.

Qualifications

• BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
• 7 years of experience in the medical device industry
• Familiar with QSR / GMP regulations
• Experience with Microsoft Office Tools and Solid Works required
• Pharmaceutical industry experience a plus
• 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

Skills

Mechanical engineering

SolidWorks

MS Office

Technical problem solving

Education

BS in Mechanical Engineering

Tools

SolidWorks

Microsoft Office

Job description

Sun Pharma in the United States is seeking a Mechanical Engineer to provide sustaining engineering support for existing medical products as well as new projects.

BS in Mechanical Engineering preferred; 7 years of medical device experience; proficiency with SolidWorks and MS Office; familiarity with QSR/GMP; ability to interpret technical issues and contribute to design controls, risk analysis, and regulatory submissions.