Engineering Manager - New Product Development

Enovis•Austin, TX

14h•Hybrid

About The Position

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.

Requirements

10+ years of design / development experience
BS in Mechanical Engineering or equivalent
Experience in medical devices and/or orthopedics preferred
Experience in managing engineering personnel preferred
Ability to effectively present information and respond to questions from groups of managers, clients, and customers
Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysis
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems
Experience with 3D CAD packages (i.e. Solidworks, NX, ProE, etc)

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 characteristics
Conferring with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing, and Regulatory); accepts and completes tasks as assigned
Creating 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 Files
Assuring compliance to FDA and ISO regulations and internal procedures
Establishing and maintaining project schedule and budget
Reviewing designs for feasibility, accuracy and technical soundness
Defining and implementing testing requirements associated with projects
Participate in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees
Collaborate / lead other engineering personnel in formulating project plans, designs, cost estimates, and specifications
Assures 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 documents
Working with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development
Identify new design methods and materials to improve productivity and competency within Product Development team
Ability to lead product development engineers and assist the Director of Global New Product Development with New Product Development projects
Assist with administration of personnel functions, including:
Monitoring of team member capabilities to drive project task efficiencies
Hiring and mentoring of engineers and support personnel in product development team
Identify the need for and assist with hiring of new personnel
Analyze and recommend resources needed to meet project goals
Train new department employees on department procedures, work instructions, forms, and any other aspect that will affect their responsibilities