Product Development Engineer in Thousand Oaks, California at Implant Direct

Date Posted: 9/30/2018

Job Snapshot

Job Description

Job ID: IMP000602

About Us

Implant Direct is one of the fastest growing major dental implant companies in the world today. We’re one of the many operating companies within Danaher Corporation’s dynamic portfolio of dental companies.  

Implant Direct operates a state of the art manufacturing facility in Thousand Oaks, California. We manufacture and distribute a broad range of value priced surgical, prosthetic and regenerative solutions to dental professionals in the US, Canada, and around the globe. We design and develop products which make high quality implants more accessible to patients around the world. We educate dentists on how to place implants and improve their patient care.

If you are interested in working in a lean, fast moving, entrepreneurial environment where you can learn, grow and make a difference, join us at Implant Direct. 


Description

The Product Development Engineer performs technical activities of assigned projects to ensure medical device is in compliance with applicable regulatory requirements and quality control standards.  Develops specifications and requirements for new product introductions.  Plans, schedules, conducts, and coordinates design control activities.  Prepares and reviews engineering documentation and performs a variety of complicated tasks requiring a wide degree of creativity and latitude.  
PRIMARY DUTIES & RESPONSIBILITIES:
  • Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
  • Perform project team leader activities to coordinate, collect, disseminate and document information for new product introductions. 
  • Monitor design control project activities to achieve an “on-time” result including follow-up with all other project participants to ensure timely response to action items, conducts daily management and regularly reports status of projects to upper management.
  • Conduct risk management activities and document results ensuring compliance with internal procedures and ISO-14971. 
  • Conduct DFMEA (Failure Mode Effect Analysis) activities, including structural analysis, mechanical testing, tolerance studies and documentation. 
  • Conduct biocompatibility evaluations and generate documentation ensuring compliance with internal procedures and ISO 10993-1. 
  • Generate documentation of Technical Files per CE Marking requirements. 
  • Check dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
  • Generate of drawings, models, sketches and designs based on company standards.
  • Develop engineering protocols/reports, initiates Change Orders (CO) and prepare needed engineering documentation. Assist with additional new product development related tasks.

Job Requirements



Qualifications

EDUCATION:
  • Bachelor’s degree in Mechanical Engineering required.
EXPERIENCE:
  • 5 years of experience in product development and project management required.  
  • 5 years of experience working with SolidWorks program including 3 years FEA (finite element analysis) using SolidWorks
  • Ability to interpret engineering drawings and geometric dimensions and tolerances.
PREFERRED QUALIFICATIONS:
  • Prior work experience in medical devices preferred
  • Prior experience working with Microsoft Office Project
  • Effective communication and organizational skills
  • High level of technical writing skills
Implant Direct is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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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 industrial solutions. Our globally diverse team of 59,000 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 #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 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.