Engineer II - Process Engineering
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Working as a Engineer II, you will be responsible for supporting the Packaging Operations & Manufacturing Engineering in the design, development, implementation & improvement of class I, II & III medical devices including new product development & maintenance of released products. Provides manufacturing expertise to create, document & implement manufacturing processes and respective procedures & documentation including but not limited to equipment & process validations. Excellent communications and analytical skills, a self- starter with a Bachelors’ degree in Engineering or Engineering Technology and three years' or more of process engineering experience will be essential for this position. This position will be located at our manufacturing site Ave Maria, Southwest Florida.
Essential Duties and Responsibilities:
- Support laser marking/welding, EDM & assembly processes.
- Assist in the selection, installation & validation of manufacturing equipment utilizing project management tools, Risk Analysis/pFMEA & Lean Manufacturing techniques.
- Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation.
- Participate in defining Preventative Maintenance programs for production equipment & tooling.
- Write & execute engineering studies/DOE’s, Validation IQ, OQ & PQ protocols & reports, SOPs & Gage R & Rs.
- Develop an understanding of the current manufacturing processes and identify targets for improvement in operation efficiencies.
- Provide process and equipment expertise and support for daily for production efforts.
- Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Production Department/and or Packaging Department to ensure cost effective new product development and introduction into manufacturing.
- Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
- Identify issues & risks to ensure sensible and cost effective new product development & introduction into manufacturing.
- 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.
- Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
- Develop a continuous improvement culture, skills sets & tools to enhance quality & operational excellence.
- Investigate & test in time reliability & quality improvements.
- Drives automation to replace the manual processes.
- Applies statistical methods to estimate future manufacturing requirements & potential.
- Confers with vendors to determine product specifications & arrange for purchase of equipment, materials, or parts & evaluate products according to specifications & quality standards.
- Analyze & plan workforce utilization
- Stay current with methods used in the medical device industry to advance technologies.
- Stay current with ASTM/ISO/FDA & internal quality policies.
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 Mechanical, Manufacturing or Industrial Engineer.
3 years Process Engineering experience with proven experience in the areas of work flow optimization, productivity efficiency and work measurement, preferably from pharmaceutical or medical device environment.
Experience with CNC machining preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work independently & effectively with cross functional teams.
Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
Familiar with clean room practices.
Machine, Tools, and/or Equipment Skills:
Metal cutting equipment, finishing equipment, laser equipment, custom tool fixturing - some with electro/mechanical or pneumatic activation.
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the 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 regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. To bend frequently and life 30 lbs. on a regular basis.
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.