This position will provide mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects. The ideal candidate
will have experience in the biomedical field. Must additionally have the ability to interpret and resolve technical and design issues.
ESSENTIAL FUNCTIONS: (Include percentage of time for each)
Provides support for existing products, product investigations and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements
Prepares 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
Performs and completes mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate
Participates in project teams and assists with project plan definition, estimation, scheduling, tracking, and reporting for related projects
Ensures 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
Contributes to new and supplemental regulatory submissions
Trains and/or provides direction to technicians ; may train manufacturing personnel and /or suppliers when required
Contributes ideas to or generates Intellectual Property submissions
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.
SKILLS & ABILITIES: (Include job complexity, judgement, physical and visual demands)
Reports To: Title(s): Engineering Manager
EDUCATION AND EXPERIENCE:
BS/Mechanical Engineering with 3-5 years of experience in the medical device industry preferred.
Associates in Mechanical Engineering or relevant experience will be considered .
Familiar with QSR / GMP regulations.
Microsoft Office Tools and Solid Works is required.
Pharmaceutical industry experience a plus.
10% domestic travel may be required.