Manufacturing Engineer - Prototype
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Working as Manufacturing Engineer for the Prototype Department, you will support the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. This includes design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Also, will provide manufacturing engineering expertise to create, document and implement required procedures and documents. A Bachelor’s degree in Engineering or Engineering Technology along with strong analytical and communication skills and experience in SolidWorks is essential for this position. This position will be located in Naples, Southwest Florida. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
- Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
- Assist ME to develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
- Lead/support process improvement initiative with ME guidance.
- Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation.
- Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
- Develop an understanding of the current manufacturing processes and identify targets for improvement in operation efficiencies.
- Develop manufacturing Work Instructions with ME review and approval.
- Provide process support on manufacturing technical issues with ME guidance.
- Support ME in cleanroom for assembly of components for New Projects/ Process.
- Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
- Support ME in regards to packaging design/and or production specifications into manufacturing.
- Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
- Support ME with Development of protocols and coordinate validation of equipment and processes.
- Stay current with methods used in the medical device industry to advance technologies.
- Investigates and test in time reliability and quality improvements
- Drives automation to replace the manual process as much as possible
- Ensure Information and documentation is consistently accurate
- Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
- Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards with approval from ME.
- Support ME in Estimation of production times, staffing requirements, and related costs to provide information for upper management decisions.
- Applies statistical methods to estimate future manufacturing requirements and potential.
- Develop process and equipment expertise and knowledge for setting up router for similar products.
- Support ME in Identifying issues and risks to ensure cost effective new product development and introduction into manufacturing.
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree in Engineering or Engineering Technology is required.
Prior experience in manufacturing from internships, co-op terms or work experience strongly preferred.
CNC machining experience would be a plus.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work independently and effectively with cross functional teams.
Basic understanding of manufacturing processes.
Detail oriented with strong analytical skills.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite, CAD and/or SolidWorks.
SPC (Statistical Process Control) knowledge preferred
Machine, Tools, and/or Equipment Skills:
Working knowledge of machining and manufacturing including Lathes and Mills.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.