This position is responsible for investigating, leading, planning, developing and implementing the more complex product design change projects in support of existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort.
Job Details:
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.
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
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.
Background Experiences
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.