Sustaining Engineer II - Spark Life Solutions Inc
Lansdale, PA 75074
About the Job
Roles & Responsibilities:
- Maintain and follow Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
- Collaborate, maintain cross-functional partnerships and coordinate activities as necessary with groups that include but are not limited to supplier quality, purchasing, manufacturing engineering, quality compliance, regulatory, and system engineering.
- Manage and lead multiple projects simultaneously.
- Evaluate and communicate business (timing, cost) impact of design changes.
- Lead and execute product design change projects from evaluation through validation.
- Develop project schedules, attend meetings, coordinate resources and prepare reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders
- Provide technical assistance and leadership in the planning and implementation of complex design change projects to develop and qualify new materials, molds, etc.
- Assist in the completion of engineering tasks or projects lead by more experienced engineers.
Education & Experience:
- BS in mechanical or related engineering field with at least 3 yrs relevant work experience in the medical or regulated industry preferred
- Experience in a manufacturing environment for designing, specifying, assembling, and validating raw material, sub-components, and finished good product.
- Experience in catheter manufacturing processes and/or catheter prototyping required.
- Additional experience in manufacturing processes for other types of medical devices a plus.
- Excellent knowledge of material and product test methodology
- Excellent understanding of material capabilities and manufacturing processes
- Thorough understanding of medical device processes and effect on product performance preferred
- Excellent analytical and problem-solving skills.
- Thorough knowledge of statistical techniques, DMAIC/six-sigma certification preferred.
- Knowledge of equipment and process validations, including development of protocols and execution of protocols.
- Successful experience leading project teams is preferred.
- Thorough knowledge of equipment and tools in laboratory testing and inspection systems.
- Knowledge of GMP/FDA regulations preferred.
- Ability to create and work from engineering drawings.
- Excellent communication skills both verbal and written.
Source : Spark Life Solutions Inc
