Sr. Product Development Engineer-Shoulders

Enovis Corp; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical technology company in Austin, TX is seeking a Senior Product Development Engineer to participate in the design and development of surgical instruments. The role requires a minimum of 8 years of experience, expertise in SolidWorks, and a commitment to regulatory compliance. Candidates should have a background in Mechanical or Biomedical Engineering, and experience in the medical device industry is preferred. The position involves collaboration across teams to ensure high-quality outcomes.

Qualifications

• Minimum of 8 years of design/development experience required.
• Strongly desirable engineering co-op or internships experience.
• Knowledge of Word/Spreadsheet software and contact/change management systems.

Responsibilities

• Participates in all aspects of the projects from proposal to final design/release.
• Collaborates across multifunctional teams to define project requirements.
• Assures compliance to FDA and ISO regulations and internal procedures.

Skills

Analytical thinking

Attention to detail

Problem solving

Project management

Technical skills

Oral communication

Written communication

Quality management

Business acumen

Judgment

Diversity

Education

BS in Mechanical Engineering, Biomedical Engineering, or equivalent

Tools

SolidWorks

Job description

## **Who We Are****ABOUT ENOVIS**Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .**What You'll Do**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..As a key member of the Surgical R&D 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**Reports To:** Sr. Engineering Manager**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 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 Total Shoulder 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 (Solidworks) + 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 Product Development with New Product Development projects* Attends cadaver labs for learning purposes* To perform the job successfully, an individual should demonstrate the following competencies: + 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 + 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 potentially unsafe conditions; uses equipment and materials properly***Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.*****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* Knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems* Experience with 3D CAD packages (SolidWorks preferred)**Desired Characteristics:*** 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:*** 10%**Work Environment:*** While performing the duties of this job, the employee is exposed to the manufacturing environment as required by local ordinance* While performing the duties of this job, the employee is exposed to the office environment as required by local ordinance* Employee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver lab* The noise level in the work environment is usually moderate**Physical Demands:*** 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