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.