Product Sustaining Engineer in Thousand Oaks, California at Implant Direct

Date Posted: 3/9/2018

Job Snapshot

Job Description

Job ID: IMP000505

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. 


Key responsibilities of the R&D Sustaining Engineer involve design,
product improvement, testing and analysis utilizing a variety of engineering
disciplines. Verify, validate and implement design changes to currently marketed
products in support of product development,
quality, manufacturing, customer service, sales, marketing and procurement
department efforts to improve product design, quality, customer service and
cost while adhering to internal quality system procedures in a regulated,
medical device industry.


Participate in line extension or change
projects in cross functional teams.

Ensure that line extension and change
project activities are in compliance to the product development procedure, to
the change control and to the design change procedures as well as to applicable
regulatory and quality system requirements.

Provide necessary product documentation
for Design History File according to internal procedures and in compliance with
MDD and applicable standards (21 CFR 820, ISO 14971; and ISO 13485).

Participate in cross functional impact
assessment of proposed changes (engineering change requests ECR).

Review and approve engineering change
orders (ECO) as required.

Lead or participate in troubleshooting, failure
analysis, root cause analysis, CAPA, customer complaint investigation, and
process improvement Kaizen events. 


job successfully, an individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of the
knowledge, skill, and/or ability required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential

Job Requirements



Bachelor’s degree in Mechanical Engineering or equivalent strongly

A minimum of 3+ years experience in
medical device or pharmaceutical industry in R&D or Manufacturing
Engineering department with knowledge of design control and transfer using Solidworks.


Ability to read and
interpret documents, in English, such as safety rules, operating and
maintenance instructions, procedure manuals, drawings and blue prints. Excellent
communication skills, both written and verbal in English.

Ability to work
with mathematical concepts such as probability and statistical inference, and
fundamentals of plane and solid geometry and trigonometry. Ability to apply
concepts such as fractions, percentages, rations, and proportions to practical
situations. Experience with engineering calculations


REASONING ABILITY: Ability to apply common sense
understanding to carry out detailed but uninvolved written or oral
instructions. Has knowledge of commonly-used concepts, practices, and
procedures and relies on experience and judgment to plan and accomplish goals.
Ability to solve practical problems and deal with a variety of concrete
variables in situations where only limited standardization exists. Ability to
interpret a variety of instructions furnished in written, oral, diagram, or
schedule form.



  • Effective
    communication and organizational skills

  • Experience
    with SolidWorks program

  • Ability
    to interpret engineering drawings and geometric dimensions and tolerances

Experience with performing root cause

Knowledge of risk management ISO 14971, ISO 13485
and US FDA 820

Good technical understanding and experience in
project management

Familiar with writing test protocols and reports

Excellent interpersonal skills

Ability to communicate effectively across the
organization, as well as various groups such as Regulatory, QA, RA, Supply
Chain, internal customers (Marketing, Customer Service, Sales) and external

Critical thinker, detail oriented while overseeing
multiple tasks for several projects

Strong Problem Solving skills (Root cause analysis,

Good knowledge of assembly and manufacturing

Working knowledge of design control (med device

Requires knowledge in ability to design and execute
protocols studies

Ability to lead small to med size
projects (Project Management skills)

Working knowledge of SOLIDWORKS 6


PHYSICAL DEMANDS: The physical demands described
here are representative of those that must be met by an employee to
successfully perform the essential functions of this job.  Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the
employee is regularly required to use hands to finger, handle, or feel objects,
tools, or controls, and to type on a keyboard. 
The employee frequently is required to stand, walk, climb stairs, sit,
reach with hands and arms, and talk or hear.

Specific vision abilities required by this job
include close vision, distance vision, color vision, peripheral vision, depth
perception, and the ability to adjust focus.

WORK ENVIRONMENT: The work environment
characteristics described here are representative of those an employee
encounters while performing the essential functions of this job. The noise level
in the work environment is usually quiet.

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.