Senior Product Development Engineer 1

Davita Inc.; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Join Enovis as a Senior Product Development Engineer, where you will play a crucial role in transforming patient care through innovative design in the medical technology field. You will collaborate with engineers and surgeons, ensuring compliance and excellence in the development of surgical instruments and implants. This position emphasizes quality, technical expertise, and the ability to manage complex product development processes, contributing to better patient outcomes.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Spending and Savings Accounts

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Qualifications

• Minimum of 8 years design/development experience.
• Strong background in medical devices and working in regulated industries.
• Ability to apply advanced mathematical concepts and operate 3D CAD software.

Responsibilities

• Participates in all aspects from proposal to final design/release.
• Collaborates with cross-functional teams to create product designs.
• Maintains compliance with FDA and ISO regulations.

Skills

Analytical

Design

Problem Solving

Project Management

Technical Skills

Oral Communication

Written Communication

Quality Management

Business Acumen

Diversity Awareness

Safety Awareness

Education

BS in Mechanical Engineering

BS in Biomedical Engineering

Tools

3D CAD packages (SolidWorks preferred)

Job description

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 the 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:
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.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.

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
• 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
• To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems
• Experience with 3D CAD packages (SolidWorks preferred)

Travel Requirements:

• Less than 15%

Desired Characteristics:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
• 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 materialsproperly

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

What does creating better together mean to us at Enovis? Discover the "why" behind our purpose, values and behaviors:

Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package that includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

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. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

Join us in creating better together.

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 www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.