Senior Medical Device Engineer – Sustaining & Compliance

SUN PHARMA; Billerica (MA); On-site; USD 116,000 - 140,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Vacation time

Sick time

Job summary

Sun Pharmaceuticals in the United States is seeking a Mechanical and Electromechanical Engineer to provide sustaining engineering for existing medical products and contribute to new projects.

You will support product investigations, develop design control documents, perform tests, and help ensure compliance with QSR/GMP/ISO 13485 in a fast-paced environment with cross-functional teams.

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

Skills

SolidWorks

Microsoft Office

Education

BS in Mechanical Engineering

Associates in Mechanical Engineering or relevant experience

Job description

Sun Pharmaceuticals in the United States is seeking a Mechanical and Electromechanical Engineer to provide sustaining engineering for existing medical products and contribute to new projects.

You will support product investigations, develop design control documents, perform tests, and help ensure compliance with QSR/GMP/ISO 13485 in a fast-paced environment with cross-functional teams.