Staff Product Development Engineer

2 weeks ago

Austin, United States Enovis Full time
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.

Enovis History

In April of 2022, Colfax, which includes orthopedic leader DJO, 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.

What You'll Do

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:

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