Engineering Manager, KneesReports To: Director, Global NPD KneesLocation: Austin TexasBusiness Unit Description: Driven by Enovis' desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today's changing healthcare environment.Job Title/High-Level Position Summary: In order to facilitate the achievement of company goals, the Engineering Manager, Knee NPD – Austin will lead, manage, and ensure the successful completion of the development of products as defined by the company. This includes mentoring team performance and ensuring that the engineering team is operating effectively to achieve set objectives, maintaining accountability for the oversight of Austin based projects, participating in cross-functional development teams and collaborating with the business and surgeon leadership to execute projects from concept through commercialization.
The Engineering Manager, in a player / coach role, is also responsible for managing internal and external design, development, testing, and manufacturing suppliers and defining and managing the product development scope of work to ensure product safety, quality, performance, and cost requirements are met.Key Responsibilities:Lead a team of biomedical engineers, mechanical engineers, and/or engineering technician(s) either direct or indirect, in developing and bringing to market, new innovative medical products, that provide true advances in clinical outcomes by:Identifying and documenting surgeon requirements and product characteristicsConferring with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing, and Regulatory); accepts and completes tasks as assignedCreating product designs and documentation used to substantiate those devices (i.e. risk assessments, engineering specifications, verification / validation activities, design review documentation, etc.)Using 3D Modeling to develop concepts and mechanism design (i.e. NX)Compile Design Dossiers or Design History FilesAssuring compliance to FDA and ISO regulations and internal proceduresEstablishing and maintaining project schedule and budgetReviewing designs for feasibility, accuracy and technical soundnessDefining and implementing testing requirements associated with projectsParticipate in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employeesCollaborate / lead other engineering personnel in formulating project plans, designs, cost estimates, and specificationsAssures proper preparation of documentation as required per project plans including user needs, surgeon feedback / IP, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documentsWorking with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product developmentIdentify new design methods and materials to improve productivity and competency within Product Development teamAbility to lead product development engineers and assist the Director of Global New Product Development with New Product Development projectsAssist with administration of personnel functions, including:Monitoring of team member capabilities to drive project task efficienciesHiring and mentoring of engineers and support personnel in product development teamIdentify the need for and assist with hiring of new personnelAnalyze and recommend resources needed to meet project goalsTrain new department employees on department procedures, work instructions, forms, and any other aspect that will affect their responsibilitiesMinimum Basic Qualifications:10+ years of design / development experienceBS in Mechanical Engineering or equivalentExperience in medical devices and/or orthopedics preferredExperience in managing engineering personnel preferredAbility to effectively present information and respond to questions from groups of managers, clients, and customersAbility to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business communityAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutationsAbility to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysisAbility to define problems, collect data, establish facts, and draw valid conclusionsAbility to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variablesTo perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systemsExperience with 3D CAD packages (i.e.
Solidworks, NX, ProE, etc)Travel Requirements:Less than 15%Work Environment:Employee is expected to work in varying environments, including office setting, mechanical testing lab, manufacturing environments, and cadaver labThe noise level in the work environment is usually moderateFlex schedule of in-office work Tuesday through Thursday required; surgeon customer interface may require in-office work schedule in addition to in-office workCurrently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.