About this opportunity
Prostaffworkforce lists this Senior Device Engineer opportunity in billerica, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
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.
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Worksite address
billerica, MA, 01821, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.