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