Provide sustaining engineering support for moderate to complex equipment and process improvement projects and implementation assignments in manufacturing operations including automated machines. Engineering and Operations activities may include planning, developing, designing, troubleshooting, installation and/or any other aspect of Engineering or Operations work.
Essential Duties and Responsibilities:
- Plan, design, develop and execute production throughput and/or quality improvement projects including all necessary documentation.
- Designs, improves and implements production equipment/processes, fixtures/jigs for production equipment and assembly to improve product quality and increase productivity or reduce costs.
- Hands on investigation and troubleshoot manufacturing issues.
- Develop test plans, validation IQ/OQ/PQ protocols, test protocols. Execute protocols and write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.
- Collaborate and provide technical guidance with equipment developers/manufacturers and suppliers to transition and qualify new equipment.
- Collaborates and communicates with company interdepartmental groups including Regulatory, Quality Assurance, R&D and Process Engineering.
- Provides manufacturing engineering feedback on new products and processes.
- Develops and maintains project timelines and provides updates and feedback to project leadership.
- Accomplishes tasks while conforming to the company quality system procedures.
- This position assumes and performs other duties as assigned
- Bachelor's degree (BS) in Mechanical Engineering, Bioengineering, or related field from four-year college or university.
- 5+ years of relevant industry experience and/or training.
- Proficiency in SolidWorks 12 or above
- Experience supporting high volume assembly lines, medical device preferred
- Experience with wide variety of equipment needed to for process or assembly of product
- Excellent communication (written and verbal) and personal interaction skills.
- Proven ability to work hands-on in a fast-paced environment.
- Proven ability to multi-task, prioritize projects, and maintain timelines.
- Flexibility in a changing environment.
- Detail oriented and organized.
- Must be able to work in fast paced environment with broad experience with equipment and processes.
- Programmable positioners, sensors and design for part fixtureing
- Working knowledge of Machine Vision applications
- Semi-Automation or automation experience is preferred.
- Experience with Lean manufacturing principles a plus.