Mechanical Design Engineer II; Manufacturing & Tooling – Medical Devices

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and support continuous improvement in production.

The Mechanical Design Engineer II project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business.

Area of work involves manufacturing processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor. Evaluates, selects, and applies engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications to equipment, tooling, and fixturing on the production line.

• Solve problems and implement innovative solutions.
• Create designs and drawings for Engineering, Production, and Research and Development.
• Develop new equipment and fixtures and their related processes for medical devices and components.
• Execute detailed root cause analysis and recommend vetted solutions.
• Communicate and explain problems and solutions cross-functionally and interdepartmentally.
• Approach problems from a detail-oriented perspective.
• Suggest independent recommendations for project approaches, scope, and tactics.
• Support production; creating and maintaining documentation.
• Monitor equipment performance and identify and implement process improvement activities to increase or optimize yield, efficiency, and/or throughput.
• Demonstrate an understanding of quality, operational, and financial systems, company products, and internal customer requirements and how the project impacts the objectives of the business.
• Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixtures on the production line.
• Perform equipment qualifications.
• Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project.
• Develop specifications of tooling, fixtures, or pieces of equipment.
• Coordinate with the appropriate suppliers and other external resources needed in developing and implementing improvements.
• Participate in project planning and scheduling.
• Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation.
• Perform other activities requiring knowledge of principles and techniques commonly employed in specific areas of projects.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

• Bachelor's degree in Engineering or related technical field with 1+ years relevant engineering experience, or equivalent combination of education and technical experience.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications.
• High degree of accuracy and attention to detail.
• Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously.

• Engineering experience in a manufacturing environment recommended; medical device industry preferred.
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes.

• General office environment; class 10,000 cleanroom.
• Willingness and ability to work on site.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 15 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be…