This position conducts engineering activities and tasks to design and develop equipment, fixtures and processes for medical device manufacturing.
• Design, develop, and document equipment and fixtures for Operations as needed
• Identify equipment, fixture, service, design and fabrication suppliers; assess supplier capability and recommend their use.
• Specify equipment qualification requirements and perform qualification activities.
• Provide equipment subject matter expertise on project teams which are introducing new products or implementing process changes.
• Analyze, troubleshoot and resolve issues relating to the safety, ergonomics, efficacy, quality and cost of equipment, fixtures and processes.
• Conduct activities, tasks, and documentation according to the quality system requirements.
• Working Conditions Ability to demonstrate dexterity sufficiently to conduct soldering, joining, machine operations, and other manual assembly operations. Ability to lift up to 50# routinely; 75# occasionally. Occasional travel for long distances by commercial means.
• A four-year technical degree from an accredited institution or acceptable equivalent.
• Five years of engineering experience with two years experience in an equipment engineering role.
• Ability to work well with others in a team setting.
• Ability to communicate effectively across the organization and external associates.
• Ability to conduct complex statistical, geometric, and mathematical calculations.
• Ability to conduct responsibilities substantially free from routine supervision.
• Ability to read, understand, and create engineering drawings on common engineering software.
• Ability to work efficiently on common office computer hardware and software.