Vention Medical Sr. Product Development Engineer in Boulder, Colorado
Job SummaryA high-performing individual that will design and develop medical devices fromconcept through market introduction on a contract basis for client companies.The desired individual will possess a broad range of medical device design anddevelopment skills and experience, as well as depth of knowledge in severalclinical, product and technical areas. The ideal candidate is aself-motivated individual who is excited by the prospect of working in adynamic, entrepreneurial environment.Essential Job Duties and Responsibilities* Develops new concepts from initial design to market release.* Investigates and evaluates existing technology.* Designs and implements new methodologies, materials, machines,processes or products to bring concept to market, including essentialproduct and process documentation.* Participates in the organization and execution of interdepartmentalactivities to ensure the completion of projects on schedule and within budgetconstraints. Conducts feasibility studies of the design to determine abilityto function as intended.* Maintains detailed documentation throughout all phases of research anddevelopment.* Prepare project plans that specify project phases, tasks, taskinterdependencies, durations, resource assignments, and costs. Conductrisk analysis for products under development.* Interacts with customer and supplier companies in a professional manner;proactively communicates with them to ensure an ongoing two-way exchange ofinformation. Coordinates activities with outside suppliers and consultants toensure the delivery of supplies or services needed to meet scheduledtimelines.* Partners with Program Managers and technical staff to generate and developconcepts, prototypes and developed products / processes for new medicaldevices.* Line management of junior resources. Ensures that all direct reports areefficiently utilized an d billable at target levels, and assists in thedevelopment and mentoring of direct reports.* Participates in brainstorming and design reviews. Maintains standards ofexcellence in all Product Development processes. Generates innovative conceptsfor new medical device designs to satisfy clinical requirements and meet orexceed customer expectations.* Any other duties as assigned.Education and Experience Requirements* Bachelor's degree in Mechanical, Biomedical Engineering or relateddiscipline is required.* Minimum of 5 years of medical device design and development experience isrequired.* Familiarity with design for manufacturability is desired.* SolidWorks 3D CAD proficiency.* Knowledge of probability and statistics.* Familiarity with FDA QSR and ISO 13,485 medical device regulations.* Depth of knowledge in one or more clinical areas.* Depth of knowledge in one or more product areas.* Depth of knowledge in one or more technical areas, for example finiteelement analysis.Skills and Abilities* Demonstrated ability to bring products from concept to market.* Ability to interact with client companies in a professional manner.* Efficiency in the management of resources.* Customer focus with excellent communication skills, written and oral.* Flexibility, persistence, resourcefulness, a drive to succeed, andan entrepreneurial spirit.Working Conditions and Physical DemandsTo perform this job successfully, an individual must be able to perform eachessential duty satisfactorily. The requirements listed above arerepresentative of the knowledge, skill, and/or ability required.Reasonable accommodation may be made to enable individuals with disabilitiesto perform the essential functions.