Engineering Manager - New Product Development

Job Description :

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

As a key member of the Surgical Knee New Product Development 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, Knee New Product Development

Reports To : John Green

John Green

Location : Austin, TX

Austin, TX

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.

Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee®, the only dual-pivot knee system on the market, and AltiVate Reverse® Shoulder, a market-leading system, based on the design principles of the RSP® Shoulder, which has demonstrated excellent clinical outcomes at 10 years.

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 will lead, manage, and ensure the successful completion of the development of products as defined by the company.

This includes managing and mentoring team performance and ensuring that the engineering team is operating effectively to achieve set objectives, participating in cross-functional development teams, and collaborating with the business 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. Solidworks)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 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 the Product Development team
• Ability to lead product development engineers and assists the Director of Global New Product Development with New Product Development projects
• Administration of engineering 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 responsibilities
• Contribute to the intellectual property position of the company via invention and patent applications
• Maintain basic knowledge of competitive technologies, in addition to medical, clinical, technical and biomedical developments in the field
• Maintain communications with internal and external, customers and suppliers
• Assist and support other employees and teams as necessary
• Other responsibilities assigned by director including attending trade shows, surgery and other corporate functions associated with role as an Engineering Supervisor
• Be aware of and comply with regulatory requirements that are applicable to Enovis Surgical, including but not limited to 21CFR820 & other MDR regulations as applicable
• Develops detail engineering drawings, CAD modeling and release through design change system; understands GD&T and can apply it in tolerance stacking activities
• Works through internal prototype shop or contract through external vendors on developing prototypes.
• Schedules and directs product team meetings as needed in the absence of engineering management, assuring timeliness of project execution
• 40% of time is spent in a resource capacity, 60% of responsibilities are in leadership / managerial activities

Minimum Basic Qualifications :

• 8+ years of design / development experience
• BS in Mechanical Engineering or equivalent
• Prior experience with 3D CAD packages (i.e. Solidworks, NX, ProE, etc)
• Prior experience in PLM and ERP systems (i.e. Agile, Teamcenter, Oracle, JDP, etc.)
• To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software;

internet software; contact / change management systems

Desired Qualifications :

• 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

Travel Requirements : (SELECT ONE)

10-25%

Physical Requirements / Work Environment :

While performing the duties of this job, the employee is regularly required to sit, talk, and hearThe employee frequently is required to sit and use hands to operate computer keyboard, and telephone.

The employee is frequently required to stand, walk, and reach with hands and armsThis position works in a typical office / manufacturing / warehouse environmentThe employee must occasionally lift and / or move up to 30 poundsThe noise level in the work environment is usually moderateThis position works in a typical office environmentPerform job duties for 8 or more hours a daySpecific vision abilities required by this job include close vision, color vision, and ability to adjust focus

• While performing the duties of this job, the employee is exposed to the manufacturing environment
• While performing the duties of this job, the employee is exposed to the office environment
• Employee is expected to work in varying environments, including office setting, mechanical testing lab, 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 on Fridays as required

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.

Watch this short video and discover what creating better together means to us at Enovis :

We offer a comprehensive benefits package which 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 Services

ABOUT ENOVIS

EQUAL EMPLOYMENT OPPORTUNITY :

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.

We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law.

We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS™

EOE AA M / F / VET / Disability Statement