Mechanical Engineer, R&D Knees

Enovis•Austin, TX

About The Position

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. 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 and purchasing in the design and development of surgical instruments and implants medical devices used in Total Knee Arthroplasty.

Requirements

Education: Minimum BS in Mechanical Engineering, Biomedical Engineering, or related discipline
Previous internship or Engineering Co-op experience in a regulated industry (medical, automotive, aerospace) highly preferred
Travel Requirements: Up to 5% domestic and potentially international to attend tradeshows, seminars, design evaluation/validation labs, meet with surgeons, view surgeries and visit suppliers
Analytical - Synthesizes complex or diverse information
Design - Demonstrates attention to detail
Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics
Project Management - Communicates changes and progress
Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; presentation skills required
Written Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information; writes detailed test protocols/reports
Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
Business Acumen - Understands business implications of decisions
Diversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environment
Judgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making process
Safety and Security - Observes safety and security procedures; reports on potentially unsafe conditions; uses equipment and materials properly
Capable of learning ASME GD&T standards of application to product design
Able to understand manufacturing primary processes including subtractive machining, additive manufacturing, forging, casting, plastic molding along with secondary processes including bead blasting, laser and GTAW welding, electropolishing, various coatings, passivation, laser etch and material science for application in new product development
Able to conform to FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge
Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community
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
Able to work with engineering change management systems
While performing the duties of this job, the employee is regularly required to sit, talk, and hear
The 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 arms
This position works in a typical office/manufacturing/warehouse environment
The employee must occasionally lift and/or move up to 30 pounds
The noise level in the work environment is usually moderate
This position works in a typical office environment
Perform job duties for 8 or more hours a day
Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus

Nice To Haves

Finite element analysis experience is optional
SolidWorks CAD modeling preferred, NX Unigraphics desired
Microsoft Office Suite software proficiency
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical knowledge for application of sample size determination and hypothesis testing
Knowledge in advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations

Responsibilities

Identifies User Needs of 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, 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)
Compiles Design Dossiers or Design History Files
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, 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.
Maintain communications with customers and suppliers.
Receives instructions and pre-established guidelines to perform the functions of the job
Majority of time is spent in a resource capacity