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Enovis · 1 day ago

Sr. Product Development Engineer-Shoulders

Austin, TX

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions. The Senior Product Development Engineer will participate in all aspects of product development for surgical instruments and implants, collaborating with cross-functional teams to drive innovation and improve patient outcomes.

Health CareManufacturingMedicalMedical DeviceProduct Design

No H1B

Hiring Manager

Michelle Walsh

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

Qualification

3D CAD (SolidWorks)Medical device experienceProject managementDesign documentationRegulatory complianceMechanical EngineeringAnalytical skillsQuality managementProblem solvingOral communicationWritten communication

Required

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)

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

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

Preferred

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