Engineering Manager - New Product Development

Enovis Corporation; Austin, Northern (TX, KY); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Job summary

Enovis Corporation in Austin, Texas, seeks an Engineering Manager for Knees to guide biomedical and mechanical engineers in the full development cycle of knee implants—from concept to commercialization. This role leads design, validation, documentation, and risk assessment while coordinating with surgeons, manufacturing, and suppliers.

You will mentor teams, drive project schedules and budgets, and ensure Regulatory and Quality requirements are met in a fast-paced medical device environment,

Qualifications

• 10+ years of design/development experience in medical devices or orthopedics is required.
• Strong leadership and mentoring skills with a track record of delivering complex programs.
• Experience applying FDA and ISO regulations and internal procedures to product development.
• Ability to communicate effectively with cross-functional teams and leadership.

Responsibilities

• Lead biomedical/mechanical engineers and technicians in bringing new knee products to market.
• Oversee concept through commercialization, including risk assessments and design history files.
• Collaborate with Manufacturing, Regulatory, Purchasing, and Quality to ensure schedules and budgets are met.
• Model-based design work (3D CAD) and documentation for device development.
• Manage internal and external design, development, testing, and manufacturing suppliers.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Presentation skills

Education

BS in Mechanical Engineering

Tools

SolidWorks

NX

Pro/Engineer (ProE)

Job description

Engineering Manager - New Product DevelopmentSkip to main contentThis site uses cookies and other tracking technologies to provide you with our services, enhance the performance and functionality of our services, analyze the use of our products and services, and assist with our advertising and marketing efforts. To view the cookie policy, please click **here**.#Engineering Manager - New Product Development page is loaded## Engineering Manager - New Product DevelopmentApplylocations: USA, Texas, Austintime type: Full timeposted on: Posted Todayjob requisition id: R0033126## **Who We Are****ABOUT ENOVISTM**Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.**What You'll Do**At EnovisTM we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? See for yourself.As a key member of the Research and Development Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.**Job Title:** Engineering Manager, Knees**Reports To:** Director, Global NPD Knees**Location:** Austin Texas**Business 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 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**Minimum Basic Qualifications:*** 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)**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 lab* The noise level in the work environment is usually moderate* Flex schedule of in-office work Tuesday through Thursday required; surgeon customer interface may require in-office work schedule in addition to in-office work*Currently, 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.***“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale.** We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.**What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:**Our Enovis Purpose, Values and Behaviors on VimeoWe offer a comprehensive benefits package that includes:* Medical Insurance* Dental Insurance* Vision Insurance* Spending and Savings Accounts* 401(k) Plan* Vacation, Sick Leave, and Holidays* Income Protection Plans* Discounted Insurance Rates* Legal ServicesJoin us in creating better together.