This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.
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
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
7 years of experience in the medical device industry and/or biomedical field preferred
Familiar with QSR / GMP regulations
Experience with Microsoft Office Tools and Solid Works required
Pharmaceutical industry experience a plus
Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Paid time off benefits including vacation time and sick time