Staff Product Development Engineer
Austin, TX 
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Posted 19 days ago
Job Description

Job Description:

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

As a key member of the Enabling Technolgies 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:

Staff Product Development Engineer

Reports To:

Director, R&D Product Development

Location:

Austin, TX

Business Unit Description:

Enabling Technologies

Job Title/High Level Position Summary: The Staff Product Development Engineer will design, test, and participate in manufacturing 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 Staff Product Development Engineer will be responsible for products include 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
  • Indirectly lead others including but not limited to task delegation, review/approval of documentation, and providing guidance and direction
  • Provide expert product leadership for the new development projects assigned; this includes an unrelenting attention to minimizing project delays and resource overages
  • Provides technical guidance to junior engineers throughout the entire design and development process
  • 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
  • 12+ years of professional experience (8+ years with a Masters degree)
  • Experience in medical devices and/or orthopedics
  • Experience with enabling technology (pre operative planning, navigation) preferred.
  • Familiarity with software development processes
  • 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:

  • Previous experience in a regulated environment, Medical Device, Aeronautics, Automotive or other highly regulated industry required
  • Previous experience leading projects of moderate to large scope and complexity
  • 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.

"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.

Watch this short video and discover what creating better together means to us at Enovis:

We offer a comprehensive benefits package which 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 to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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.

Company Description:

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 .

Enovis History

In April of 2022, Colfax, which includes orthopedic leader , separated from ESAB Corporation and rebranded to Enovis. In recognition of our successful history of growth and innovation, the distinctive "O" in our new Enovis logo was deliberately carried over from our Colfax logo as it represents continuous improvement - a cornerstone of our business's success that will continue at Enovis. Enovis is poised to become one of the world's leading medical technology companies.

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 .

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.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
12+ years
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