R&D Sustaining Engineer in Mexicali, Mexico at Ormco

Date Posted: 8/14/2019

Job Snapshot

Job Description

Job ID: ORM001741

About Us

For nearly 60 years, Ormco has partnered with the orthodontic community to manufacture innovative products and solutions to enhance the lives of our customers and their patients. Distinguished products range from legacy twin brackets (Inspire ICE™, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Ormco’s Insignia™ Advanced Smile Design™ provides an all-inclusive customized indirect bonding solution for increased clinical efficiency. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information, visit www.ormco.com.



Description

  • As a member of R&D Sustaining you will work closely with regulatory affairs, product development, quality, manufacturing, customer service, sales, marketing and procurement departments in support of global product registrations and product design, quality, customer service, and cost improvements.

  • Investigate and assess design history files (DHF), CE Tech Files, design specifications, test reports and manufacturing documentation to identify and resolve technical gaps and provide accurate and timely technical information for Regulatory submissions.
  • Work closely with subject matter experts to development technical justification reports.

  • Create performance verification protocols and write reports.

  • Execute test protocols, summarize data, analyze and make conclusions.

  • Prepare product drawings and illustrations for Regulatory submission. 

  • Attend appropriate meetings – technical and core team, providing updates as required.

  • Create and/or modify product design, product performance specifications, drawings, procedures, CAD models (Solidworks).

  • Create and execute Engineering Change Requests (ECR) in accordance with internal quality system procedures.

  • Conduct product testing, field failure root cause investigations and develop, verify, validate and implement solutions in accordance with internal quality system procedures.

  • Represent R&D Sustaining as a cross functional team member in support of product development, quality, manufacturing, customer service, sales, marketing, regulatory affairs and procurement department objectives.

  • Ability to read, analyze, interpret, create, and meet: product specifications, technical procedures and worldwide governmental regulations.
  • Ability to develop test protocols, execute testing, statistically analyze data, and develop conclusions. 

  • Ability to write technical reports and justifications. 

  • Excellent interpersonal skills, work well within a team and able to collaborate with and influence others

  • Excellent oral and written communication skills.


Job Requirements



Qualifications

  • Bachelors in Engineering required. BS in Mechanical or Materials Engineering preferred.

  • 3-4 years engineering experience in medical device product development and/or manufacturing environment preferred. 

  • Experience with mechanical characterization methods such as tensile, compression or modulus testing preferred.

  • FDA Quality System Regulation Part 820 and ISO 13485 experience preferred.

  • Working knowledge of SolidWorks CAD software is preferred.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.