Engineering Manager - New Product Development

About the role

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.

Key Responsibilities

• Lead a team of biomedical engineers, mechanical engineers, and/or engineering technicians 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
  • Confering with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing, and Regulatory)
  • Accepts and completes tasks as assigned
• Create product designs and documentation used to substantiate those devices (i.e. risk assessments, engineering specifications, verification / validation activities, design review documentation, etc.)
• Use 3D Modeling to develop concepts and mechanism design (i.e. NX)
• Compile Design Dossiers or Design History Files
• Assure compliance to FDA and ISO regulations and internal procedures
• Establish and maintain project schedule and budget
• Review designs for feasibility, accuracy and technical soundness
• Define and implement 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
• Work 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 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

Preferred Qualifications

• Experience with 3D CAD packages (i.e. Solidworks, NX, ProE, etc)

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.

Equal Employment Opportunity

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria 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.