Project Engineer II (Mid level) = 5 years of experience
Sr. Project Engineer = 8 years of experience
Duties and Responsibilities
- Design and develop new products for in-house production in main facility and other manufacturing sites within the corporate group.
- Perform research and testing on product concepts, new, and existing products.
- Upgrade older existing products, identifying areas to streamline or improve processes and quality.
- Provide continuing product support for manufacturing, sales and quality on design requirements, customer needs, testing, CAPA and product documentation.
- Coordinate with manufacturing at suitable stages during initial design to evaluate the designs ability to optimize for manufacturing in an efficient and economical manner.
- Insure compliance to the requirements of ISO13485 standards, FDA regulations, and Good Manufacturing Processes regarding process, design, and development of new and existing product.
- Perform DOE, correlation studies, and apply statistical analysis for product improvements.
- Apply FMEA process to implement sound engineering solutions.
- Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards, and approve prototypes.
- Develop product literature by recording, interpreting and explaining technical data and product performance.
- Responsible for product project management from prototype to full production based upon accurate project schedules and budgets.
- Design detailed project plans with engineering, manufacturing, and sales / marketing teams to manage all aspects of product development and production.
Position Qualifications and Requirements
- Bachelor’s Degree in Mechanical Engineering, Biomedical, or other related Engineering discipline.
- 5 years of design and development experience in the medical device and/or component industry (college internship experience considered).
- Design Control experience including design and process verification and validation.
- Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, SUS and GD&T.
- Experience in producing rapid prototypes.
- Knowledge of statistical methods/analysis, experience with application of Six Sigma statistical analysis, and controls
- Demonstrated knowledge of applied mechanical engineering in product design and evaluation.
- Strong aptitude for hands-on engineering testing and experimentation in a lab environment.
- Proficient in 3D CAD software (SolidWorks preferred).
- Understanding of CAE tools (FEA, CFD, etc.)
- Excellent project management skills. Microsoft Project experience preferred.
- Superior verbal and written communication skills