Process Engineer I
Location: Sarasota, FL
Supports manufacturing process improvements and new process development projects. Works on problems of diverse scope where analysis of data is utilized to make timely and effective decisions. Investigates manufacturing defects and implements effective solutions. Performs design, purchase, validation and implementation of equipment and systems used in manufacturing of medical devices.
Specific Tactical Responsibilities:
- Works closely with R&D Engineers, supporting Design Transfer activities for products entering production
- Measures and identifies opportunities for cost reduction or process efficiency improvements through process development, statistical process control, and lean-six sigma techniques.
- Develops work instructions and assists with training of manufacturing personnel
- Develops and manages projects consistent with department and corporate goals.
- Requires interaction with multiple departments internally, external material and equipment vendors and coordination of multidisciplinary tasks.
- Prepares procedures for new equipment and processes and works with Document Control to ensure final processes are implemented
- Performs process and product risk assessments and prepares reports according to company procedures
- Prepares equipment (IQ/OQ/PQ) protocols and reports
- Supports inspection and verification, development of process controls and methods, and troubleshooting of existing inspection and verification methods
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
None; must be able to participate in and lead multi-disciplined project teams.
- Bachelor’s degree in in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
- Strong engineering and analytical problem-solving skills
- Experience with or ability to learn Statistical Analysis Methodology such as Six Sigma or LEAN
- Experience with or ability to learn MS Excel, MS Word, SolidWorks and/or other CAD/CAM packages, and inspection/testing software
- Understanding of mechanical designs, drawings, and inspections
Desired Experience, Knowledge, and Skills:
- Master’s Degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
- Medical experience and/or familiarity with FDA QSR’s and ISO 13485
- Experience in a manufacturing environment which involves machining, molding, post-processing, and packaging
- Demonstrated excellence in manufacturing improvements
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.