Senior Equipment Engineer

Senior Equipment Engineer

Requirements

• BS in an Engineering discipline such as mechanical or electrical engineering with a minimum of five years’ experience or an MS in Engineering with a minimum of three years’ experience.
• Experience supporting equipment engineering in a medical device manufacturing or capital equipment manufacturing environment in a similarly regulated industry.
• Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001.
• Proficiency with CAD software (SolidWorks preferred).
• Excellent computer skills with specific skills in Microsoft Office.
• Complete Knowledge and Understanding of Equipment and tooling design: You should demonstrate comprehensive knowledge and deep understanding of your area of specialization, including principles and practices within equipment design. Strong understanding of machine design.
• Analytical and Problem-Solving Skills: You should be capable of assessing unusual circumstances using sophisticated analytical techniques. This involves identifying the root cause of problems and applying advanced problem-solving methodologies to resolve them effectively.
• Creativity and Innovation: You should be able to resolve a wide range of issues creatively, suggesting variations in approach when necessary. This implies the ability to think outside the box and propose innovative solutions to complex problems.
• Autonomy and Responsibility: At this position, you should be capable of working independently, taking ownership of projects, and making sound decisions without constant supervision and be able to assess and address a wide range of issues autonomously.
• Continuous Learning and Improvement: You should exhibit a commitment to continuous learning and improvement within their field. This involves staying updated on the latest advancements, technologies, and methodologies relevant to equipment design.

Responsibilities

• Problem-solving: This position will work on problems of diverse scope where analysis of information requires evaluation of identifiable factors by identifying and resolving technical issues that arise during the design and testing phases. This may involve troubleshooting equipment malfunctions, optimizing automation processes, or improving system reliability.
• Continuous Improvement: This position will create solutions based on limited information and precedent and adapts existing approaches to resolve issues. Uses evaluation, judgment, and interpretation to select right course of action. Continuously seeking opportunities to improve the efficiency, reliability, and safety of equipment and automation systems through innovation and iteration.
• Risk Management: This position will conduct risk assessments to identify potential hazards associated with equipment and automation designs and implementing measures to mitigate these risks.
• Collaboration: This position will work closely with other engineers, including R&D Engineers, manufacturing engineers, electrical engineers, and software engineers, to integrate different components into the design and ensure compatibility.
• Training and Support: This position will develop and provide training and technical support to manufacturing personnel or end-users to ensure proper operation and maintenance of equipment and automation systems.
• Project Management: This position will manage projects related to equipment or automation design, including setting timelines, allocating resources, and tracking progress to ensure timely delivery of deliverables.
• Outside Suppliers: This position will develop industry relationships with key suppliers to Design, build or procure improved fixtures, tooling, or equipment to increase quality, reliability, capacity, and yield.
• Write test protocols, perform tests to fully characterize new equipment or processes utilizing DOE methodology or other statistically sound methods, then write completion reports.
• This position will perform process capability assessments and establish methods to control process output for key equipment and processes.

Preferred Qualifications

• Experience in designing and integrating PLC’s into automation equipment.
• Experience with prototyping fixtures and rapid iterations to support design process.
• Experience with basic machining of parts on a milling machine or lathe.
• Experience with root cause analysis and problem solving for both technical and process issues.
• Preferred experience with Lean and Six Sigma tools.