Development Engineer II, Base Business

Posted Yesterday
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Austin, TX, USA
In-Office
Junior
Healthtech
The Role
Designs, prototypes, tests, documents, and supports development of medical device products, including mechanical surgical instruments, electronic hardware, and related software. Responsibilities include creating SolidWorks designs and engineering documentation, conducting verification and validation activities, maintaining Design History Files, coordinating cross-functional projects, communicating with vendors, and supporting FDA 510(k) submissions. The role also interfaces with physicians, manufacturing, quality, regulatory, marketing, and purchasing teams.
Summary Generated by Built In
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 www.enovis.com.

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.

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 Enabling Technologies 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: 

Product Development Engineer 

Reports To: 

Manager, Base Business-Enabling Technologies 

Location: 

Austin, TX 

Business Unit Description: 

Enabling Technologies 


Job Title/High Level Position Summary: The Product Development Engineer will design, test, and participate in development activities for company products. This includes but is not limited to interfacing with physicians and other customers to determine needs/requirements; creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure product quality. The Product Development Engineer will be responsible for products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware. 


Key Responsibilities: 

·         Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics 

·         Provide detailed design and development output for the development projects assigned; this includes unrelenting attention to minimizing project delays and resource overages 

·         Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.) 

·         Develops detailed engineering drawings using 3-D Modeling to document designs and design changes (SolidWorks) 

·         Confers with cross-functional team to identify tasks and requirements (Product Development, Manufacturing Engineers, Quality Engineers, Marketing, Purchasing and Regulatory Affairs) 

·         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. 

·         Assist in the 510(k) application process by providing official information for FDA review 


Minimum Basic Qualifications: 

·         Bachelor's degree in an engineering discipline 

·         2+ years of professional experience (1 year with a Masters degree) 

·         Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, 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. 

·         Must be experienced in MS Word, Excel and Project. 

·         Experience with 3D CAD packages (SolidWorks preferred) 


Travel Requirements: 

·         <5% of travel required 


Desired Characteristics: 

·         Experience in medical devices and/or orthopedics  

·         Familiarity with software development processes 

·         Working knowledge and requirements of ISO 13485 and 21CFR820. 


Work Environment: 

·         While performing the duties of this job, the employee is exposed to the manufacturing environment. 

·         While performing the duties of this job, the employee is exposed to the office environment. 

·         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 typical office/manufacturing/warehouse environment. 

·         The employee must occasionally lift and/or move up to 30 pounds.  

·         Perform job duties for 8 or more hours a day. 



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.

 

“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

Join us in creating better together.

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.

Skills Required

  • Bachelor's degree in an engineering discipline
  • At least 2 years of professional experience, or 1 year with a master's degree
  • Ability to apply mathematical operations for frequency distributions, test reliability and validity, and analysis
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to interpret technical instructions in mathematical or diagram form and manage abstract and concrete variables
  • Experience with Microsoft Word, Excel, and Project
  • Experience with 3D CAD packages, preferably SolidWorks
  • Experience in medical devices and/or orthopedics
  • Familiarity with software development processes
  • Working knowledge of ISO 13485 and 21 CFR 820

Enovis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Enovis and has not been reviewed or approved by Enovis.

  • Healthcare Strength — Healthcare coverage is positioned as comprehensive, with multiple medical, dental, and vision plan options plus HSA/FSA accounts. Income protection offerings are also described as robust, including life, AD&D, and short- and long-term disability coverage.
  • Retirement Support — Retirement benefits include access to a 401(k) plan with an employer match described as competitive. This adds to the overall total-rewards value even where cash compensation sentiment is uneven.
  • Leave & Time Off Breadth — Time-off provisions are described as ample, including vacation, sick leave, and holidays. Paid parental and family leave is also offered, with a stated maximum of six weeks for eligible employees after birth or adoption.

Enovis Insights

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The Company
HQ: Wilmington, DE
1,217 Employees
Year Founded: 2022

What We Do

We are a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.

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