Senior Device Engineer

Summary:This role focuses on providing mechanical and electromechanical engineering support for both existing and new medical device projects, ensuring product quality, compliance, and continuous improvement.

Responsibilities

Support existing medical products by investigating and analyzing product issues, determining root causes, and implementing effective resolutions to meet customer requirements.Prepare and maintain comprehensive product documentation, including specifications, bills of material, hazard/risk analyses, test procedures, validations, and procedures, while supporting suppliers and contract manufacturers.Conduct mechanical tests and experiments to ensure designs comply with industry standards, safety margins, reliability goals, and relevant international standards.Participate in project teams, assisting with project planning, estimation, scheduling, tracking, and reporting for engineering projects.Prioritize quality system requirements in all activities, including design, development, validation protocols, and risk assessments.Develop specifications, packaging, labeling, and all associated design control documents in accordance with project, industry, and regulatory requirements.Contribute to regulatory submissions and generate ideas or intellectual property submissions as needed.Provide training or direction to technicians, manufacturing personnel, or suppliers, and perform other duties as assigned.

Qualifications

BS in Mechanical Engineering preferred; Associate’s degree in Mechanical Engineering or relevant experience will be considered.5 years of experience in the medical device industry required.Ability to interpret and resolve technical and design issues required.Familiarity with QSR/GMP regulations required.Experience with Microsoft Office Tools and SolidWorks required.Pharmaceutical industry experience is a plus.Ability to operate production equipment, hand tools, and computer/office equipment.Physical ability to lift and move heavy boxes/equipment up to 70 lbs, and work in various environments including office, lab, manufacturing, and maintenance areas.