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ENOVIS

Global medical technology company; orthopedic solutions

Engineering Manager - Sustaining-Enabling Technologies

Engineering LeadershipUpdated on Nov 10
Full-timeAustin, TX, USA$145.3k - $175.3k

About the Job

Requirements

  • A bachelor's degree in an engineering discipline is required.
  • At least 8 years of professional experience in a regulated industry is required, or at least 6 years with a master's degree.
  • Experience in medical device product development is required.
  • Familiarity with software development processes is required.
  • Experience applying mathematical operations to frequency distribution, determination of test reliability and validity, and analysis is required.
  • Experience defining problems, collecting data, establishing facts, and drawing valid conclusions is required.
  • Experience interpreting technical instructions in mathematical or diagram form and dealing with abstract and concrete variables is required.
  • Proficiency with Microsoft Word, Excel, and Project is required.
  • Experience with 3D CAD packages is required.
  • Working knowledge of ISO 13485 and 21 CFR 820 is required.

Responsibilities

  • Manage project prioritization and resource allocation.
  • Mentor direct reports by providing technical guidance, coaching, performance management, and professional development opportunities.
  • Participate in product development, including concept generation, decision matrices, prototyping, manufacturing, and associated metrics.
  • Provide product leadership for assigned development projects, minimizing project delays and resource overages.
  • Create product designs and documentation to substantiate devices, including risk assessments, verification and validation activities, and design review documentation.
  • Develop detailed engineering drawings using 3D modeling to document designs and design changes in SolidWorks.
  • Work with cross-functional teams, including Product Development, Manufacturing Engineering, Quality Engineering, Marketing, Purchasing, and Regulatory Affairs, to identify tasks and requirements.
  • Maintain documentation for a Design History File, including Design Input Documents, Design Validation Plans and Reports, Test Protocols and Reports, and a Design Input/Output Matrix.
  • Assist with the regulatory submission process by providing information for regulatory review, including FDA 510(k), EU MDR, TGA, and PMDA submissions.
  • Schedule, coordinate, and manage multiple projects; communicate with vendors to ensure proper design transfer.
  • Create prototypes, test them, and document test results.
  • Work with products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware.

Desired Qualifications

  • Experience with enabling technology such as preoperative planning, navigation, or robotics is preferred.
  • SolidWorks experience is preferred.
  • Previous experience managing engineers is desired.
  • Previous experience developing orthopedic medical devices, including implant development or enabling technology used with orthopedic implants, is desired.
  • Previous experience leading projects of moderate to large scope and complexity is desired.

About the Company

ENOVIS

Global medical technology company; orthopedic solutions

Enovis develops and sells medical devices and services to improve patient outcomes and restore mobility. Its business has two segments: Prevention & Recovery, which covers orthopedic braces, soft goods, vascular therapy, compression garments, and hot/cold therapy, and Reconstructive, which offers joint implants and minimally invasive surgical tools. The company differentiates itself with a broad, clinically focused portfolio, a global manufacturing and service network, and the Enovis Growth Excellence program to drive continuous improvement. Its goal is to deliver better patient outcomes and sustained growth by expanding its footprint and strengthening operations, including recent acquisition of LimaCorporate.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
2022

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