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Senior Product Development Engineer

2 months ago

Austin, United States Enovis Full time

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 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:

Senior Product Development Engineer 1

Reports To:

Director, Global NPD, Hips & Cement

Location:

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:

Participates in all aspects of the projects from proposal to final design/release for the assigned project by performing the following duties. Works with a cross-functional product team consisting of product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants medical devices used in Hip Arthroplasty.

Key Responsibilities:

  • Participates as an active member of the New Product Development Team:
  • Identifies and incorporates surgeon design requirements and product characteristics
  • Confers with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assigned
  • Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification / validation activities, design review documentation, etc.)
  • Uses 3-D Modeling to develop concepts and mechanism design
  • Compiles 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.
  • Participates in surgeon symposia, focus groups and surgeon consultant meetings
  • Assists product development engineers and the Engineering Manager or Director of Shoulder ProductDevelopmentwithNew Product Development projects
  • Attends cadaver labs for learning purposes
  • Works with both the marketing team and customers to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to the customers for evaluation
  • Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix
  • Develops project plans using appropriate planning software and periodically report on the progress of the project to upper management
  • 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.
  • Maintain basic knowledge of competitive technologies, in addition to medical, clinical, technical and biomedical developments in the field.
  • Maintain communications with customers and suppliers.
  • Relies on instructions and pre-established guidelines to perform the functions of the job
  • 80% of time is spent in a resource capacity. 20% of responsibilities are in leadership activities.

Minimum Basic Qualifications:

  • A minimum of 8 years of design / development experience; engineering co-op or internships is strongly desirable
  • BS in Mechanical Engineering, Biomedical Engineering, or equivalent
  • Prior knowledge of and experience with Word Processing software; spreadsheet software; internet software; contact / change management systems
  • Prior experience with 3D CAD packages (SolidWorks preferred)

Desired Qualifications:

  • Experience in medical devices and/or orthopedics preferred
  • Experience working in a regulated industry preferred
  • Ability to 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: