Mechanical Design Engineer II (Manufacturing & Tooling – Medical Devices

Mechanical Design Engineer II

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that 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 exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications to equipment, tooling, and fixturing on the production line.

Specific duties and responsibilities include solving problems and implementing innovative solutions, creating designs and drawings for Engineering, Production, and Research and Development, developing new equipment and fixtures and their related processes for medical devices and components, executing detailed root cause analysis and recommending vetted solutions, communicating and explaining problems and solutions cross-functionally and interdepartmentally, approaching problems from a detail-oriented perspective, suggesting independent recommendations for project approaches, scope, and tactics, supporting production;

creating and maintaining documentation, monitoring equipment performance and identifying and implementing process improvement activities to increase/optimize yield, efficiency, and/or throughput, demonstrating an understanding of quality, operational, and financial systems, company products, and internal customer requirements and how the project impacts the objectives of the business, designing fixtures, acquiring off-the-shelf tooling and equipment, and implementing new fixtures on the production line, performing equipment qualifications, planning, scheduling, conducting, and coordinating detailed phases of engineering work as part of a project or as a total project, developing specifications of tooling, fixtures, or pieces of equipment, coordinating with the appropriate suppliers and other external resources needed in developing and implementing improvements, participating in project planning and scheduling, training assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation, performing other activities requiring knowledge of principles and techniques commonly employed in specific areas of projects, adhering to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures, understanding relevant security, privacy, and compliance principles and adhering to the regulations, standards, and procedures that are applicable to the Company, ensuring other members of the department follow the QMS, regulations, standards, and procedures, and performing other work-related duties as assigned.

Position qualifications - required include a 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 required, proficiency in Word, Excel, PowerPoint, Access, and other computer applications required, a high degree of accuracy and attention to detail, and excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously.

Position qualifications - desired include engineering experience in a manufacturing environment recommended; medical device industry preferred, knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired.

Working conditions include a 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, such as a printer or copy machine, for an extensive period of time each day, must be able to read, prepare emails, and produce documents and spreadsheets, must be able to move within the office and access file cabinets or supplies, as needed, must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual base salary range: $79,000 to $100,000. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.