Senior Device Engineer

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

• Operate computer/office equipment

We are seeking a Senior Device Engineer for a direct-hire opportunity in Billerica, MA. This role will support medical device engineering, product development, testing, and technical problem-solving in a regulated environment.

Full-time Onsite

Direct Hire

Pay Rate: DoE

Job Summary

This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.

Area Of Responsibility

• 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 the company 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.

Work Conditions

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell
• Close, distance and peripheral vision; depth perception, ability to focus
• Ability to operate production equipment and hand tools
• Operate hand truck
• Operate computer/office equipment
• Wear proper lab gowning and safety shoes
• Lifting and moving of heavy boxes/equipment up to 70 lbs.

Travel Estimate

Up to 10%

Qualification

• BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
• 7 years of experience in the medical device and pharmaceutical industry required
• Ability to interpret and resolve technical and design issues required
• Familiar with QSR / GMP regulations
• Experience with Microsoft Office Tools and Solid Works required

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.