Sr. Product Development Engineer - Knees

Job Description:

At Enovis™ 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 Knee Product Development Engineering, 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:
Sr. Product Development Engineer - Knee

Reports To:
Engineering Manager, New Product Development - Knee

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. 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 product development within project(s) from proposal to final design/release for the assigned project by performing the following duties. Works with a cross-functional product team consisting of developing surgeons, product development engineers, marketing product managers, manufacturing engineers, regulatory, quality engineers, project managers and purchasing in the design and development of surgical instruments and implants medical devices used in Total Knee Arthroplasty.

Key Responsibilities:

• Identifies and Incorporates User Needs of a product by engagement with Orthopedic Surgeons & Marketing
• Translations User Needs into Design Requirements/Inputs to meet market need while complying with global regulatory requirements (FDA / EU MDR) and internal/external standards
• Creates product designs that meet the user needs/design requirements
• Reviews and prepares information for invention disclosure and patents.
• Collaborates with cross-function teams (Quality, Manufacturing, Marketing, Regulatory, Purchasing, and Project Manager) on prototypes and initial production units for design evaluation, design verification, design validation and process validation.
• Create product designs and drawings that are appropriate for design for manufacturability and inspection by conducting reviews
• Identifies critical to quality product dimensions based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated
• Defines verification and validation activities relative to user needs and design requirements to reduce risks in compliance with Enovis procedures and global regulatory requirements (includes completing tolerance stack-ups, testing, finite element analysis and cadaveric design evaluation/validation within a simulating operating room environment)Works with Project Management on project plan/schedule and with management on budget plans/proposals

• Assures proper preparation of documentation as required per project plans including user needs, design requirements, risks, surgeon feedback / IP, design reviews, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documents.
• Works with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.
• Assists fellow product development engineers, engineering manager & director on development of new products.
• Attends cadaver labs for design evaluation, design validation and for educational 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
• Provides project updates to customers, upper management, and cross-functional team member on a reoccurring basis
• 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.