Senior Medical Device Engineer – Sustaining & R&D

Prostaffworkforce; Billerica (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Prostaffworkforce is seeking a Senior Device Engineer in Billerica, MA to provide mechanical and electromechanical engineering support for sustaining existing medical products and new projects in a regulated environment.

This full-time onsite role covers investigations, design controls, risk analysis, testing, documentation, and collaboration with suppliers and contract manufacturers to ensure compliance with QSR/GMP, ISO 13485, and related standards.

Qualifications

• BS in Mechanical Engineering preferred; related experience considered.
• 7 years of experience in the medical device and pharmaceutical industry.
• Ability to interpret and resolve technical/design issues.
• Familiar with QSR/GMP regulations.
• Experience with Microsoft Office Tools and SolidWorks required.

Responsibilities

• Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues.
• 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

Root cause analysis

Technical problem-solving

Regulatory compliance

Microsoft Office

Education

BS in Mechanical Engineering

Tools

SolidWorks

MS Office

Job description

Prostaffworkforce is seeking a Senior Device Engineer in Billerica, MA to provide mechanical and electromechanical engineering support for sustaining existing medical products and new projects in a regulated environment.

This full-time onsite role covers investigations, design controls, risk analysis, testing, documentation, and collaboration with suppliers and contract manufacturers to ensure compliance with QSR/GMP, ISO 13485, and related standards.