Summary: Recognized technical expert whose key duties are to provide technical support and engineering leadership during the development process, and for the maintenance of existing product, on a selective basis.
· With limited direction, execute or lead the following activities during the product development process.
· Overall cross functional project/program leadership, through final release of drawings and first production run.
· Ensure project runs smoothly achieving specification, financial and timing objectives. Take ownership for project timing and successful product completion.
· Creation, management and approval management of the overall project plan.
· Provide project updates to all levels of corporate management.
· Direct the daily activities of the cross functional team in relation to project work
· Create and manage project budget.
· Interface with cross functional management leads to manage functional resource requirements for the project.
· Concept development and prototype design.
· Lead design and business reviews during the course of the project
· Periodic review meetings with all functional groups.
· Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team.
· Provide engineering leadership in following ways:
· In support of project teams up through final release of drawings and first production run.
· Through “troubleshooting” and resolution of field issues.
· Investigation and implementation of significant cost reductions.
· Leading the organization and development of concepts for new products.
· Provide sustaining engineering support to assigned product lines helping the on-going cost reduction/product improvement activities of Change Board.
· Maintain and develop high level of knowledge of technical aspects of design or product components/systems and provide strategic direction in these areas.
· Support existing products, particularly in area of “expertise”, with Engineering Documentation and day-to-day consultation to Operations, Marketing, Technical Services, etc.
· Development and execution of test protocols and plans and risk assessments.
· Release of prints in a manner (accuracy, completeness, and timeliness) that supports the project timeline.
· Building and testing of prototypes.
· Coach assigned and unassigned engineers
· Lead or assist training of assigned engineers
· Ensure that all product development processes and activities conform to quality system
· In collaboration with QA/RA and in a pro-active manner, ensure that product development processes and activities meet appropriate domestic and international safety and quality standards
· Complete all required training applicable to assigned position.
· Additional duties as requested or required.
· Bachelor of Science degree in Mechanical, Aerospace, or Electrical Engineering from ABET accredited institution.
· Minimum 10 years of product engineering experience.
· Minimum 7 years leading large programs/projects.
· Minimum 7 years of experience working with an Engineering Change process and manufacturing Bill of Materials.
· Minimum 5 years utilizing MS project in conducting project leader role
· Discipline in initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria.
· Proven engineering expertise in specified areas. (gear design, software, motors, controls systems, etc.)
· Highly knowledgeable in the utilization of necessary; software tools, analysis equipment, measurement tools, measurement techniques, test methods, industry standards, and industry best practices, for related expertise
· High level of proficiency utilizing PC design tools to generate prototypes and convey design concepts to other functional departments.
· Ability to do layouts and detail drawings sufficient to generate prototypes and convey design concepts to other functional departments.
· Ability to coach assigned and unassigned engineers.
· Ability to train assigned engineers.
· Effective communication skills
· New Product Introduction project leadership experience in medical device industry preferred.
· Solid working knowledge of FDA regulations for Design Controls preferred.