Engineering Manager - Product Development

Job Title

Engineering Manager, Knees

Director, Global NPD Knees

Austin Texas

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.

• 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 (manufacturing engineering, purchasing, regulatory) and accepting and completing tasks as assigned
  • Creating product designs and documentation used to substantiate those devices (risk assessments, engineering specifications, verification/validation activities, design review documentation, etc.)
  • Using 3D modeling to develop concepts and mechanism design (NX)
  • Compiling 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
• Ensure 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, reviewing and monitoring quality and process improvements for new product development
• Identify new design methods and materials to improve productivity and competency within Product Development team
• 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 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 procedures, work instructions, forms, and any other aspect that will affect their responsibilities

• 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 managers, clients, and customers
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or community members
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability to apply mathematical operations to tasks such 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
• Knowledge of Word Processing, spreadsheet, internet software, and contact/change management…