Immediate direct-hire opening for a process engineer in the greater Orlando area. This is a medical device manufacturing company. They would like someone with at least 2-3 years of professional experience specifically working with medical devices. The ideal candidate will have 5 years of professional experience working with medical devices and and a Bachelors of Science in Engineering (or related field). This position will report to the Manufacturing Manager.
Relocation assistance may be considered for the right candidate.
Responsibilities for the Process Engineer
- Transition projects, manufacturing and complete engineering leadership on projects from pre-production through sustaining of the product, including equipment layout
- Utilize progressive methodology to eliminate variation, such as, Design of Experiments (DOE) and Failure Mode and Effects Analysis (FMEA).
- Support new product development and process input to design engineering by completing various manufacturing support related tasks such as tooling fixtures and validation, and identifying tolerances
- Manage suppliers through qualification and supplier audits
- Monitor and trend nonconformances and issue corrective actions to supplier through buyers
- Perform failure investigation on noncoforming material from customer returned product
- Review sampling plans on supplier components and revise as required
- Review and approve validation protocols and validation results. Perform validations as required.
- During product team meetings, assures valid Quality input relating to product design/development, production issues, and quality issues from field.
- Assist auditors and/or other associates with dimensioning and tolerancing issues
- Actively contributes to Business Unit decisions on capital expenditures, monthly financial indicators, new product development, safety/ergonomics and quality
- Helps develop training programs as required to maintain company as a progressive manufacturer (i.e., work methods, quality philosophies, controlling mfg. variances, etc.). Updates procedures and records to assure ISO/QSR compliance
- Conducts Process Capability Studies and develops Associated Corrective Action Plans
Requirements for the Process Engineer
- BS degree in Engineering (or related field) preferred
- 3+ years of experience in a manufacturing environment, medical manufacturing strongly preferred
- Knowledge of engineering and quality methods/testing
- Knowledge of metal and plastic manufacturing
- Working knowledge of Failure Mode and Effects Analysis (FMEA)
<Benefits for the Process Engineer
- Competitive salary + company sponsored benefits and PTO