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Design Assurance Engineer in Thousand Oaks, California at Implant Direct

Date Posted: 2/4/2019

Job Snapshot

Job Description

Job ID: IMP000744

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

JOB SUMMARY:
The Design Assurance Engineer is responsible for supporting projects and activities to assure quality is designed in to the new product and in the Lifecycle Management (change control).  With comprehensive knowledge of engineering and problem solving principles, he/she will apply “Good Engineering Practices” that will not only meet internal requirements, regulations and standards but exceed customer expectations.  The incumbent for this position will support various engineering duties including, (but not limited to), design verification and validations, test method validations, process validations, software validations, equipment qualifications, process validation and play a crucial part in leading a seamless transition from the design phase into production for all new products and product sustaining projects. 
ESSENTIAL DUTIES:
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle. That includes review of technical documentation during the new product development and life cycle management (DHF). 
  • Participation and reviewing of design review meeting minutes / records
  • Work closely with Regulatory, R&D, Quality and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.
  • As a Product Development Core Team member, proactively influence designs to achieve product quality and reliability targets that meet or exceed customer expectations and assures patient safety.
  • support complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways.
  • Support the establishment requirements for all verification and validation (design and process) activities.
  • Support the application of state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes.
  • Support the development of Risk Management documentation.
  • Participate and support in audits and inspections of the company and quality management systems.
  • Support SQA / SQE in the onboarding of new suppliers
  • Support CAPA related activities as CAPA owner and / or reviewer

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelor of Science in Engineering or related Engineering field
  • Minimum 2 years in QE role in product design and development in a Class II or III medical device environment
PREFERRED SKILLS:
  • Master's degree in Engineering or related Engineering field
  • Solid understanding of design control, 21 CFR 820, ISO 13485, EU MDD/MDR, MDSAP, CMDCAS, Brazil RD, Australia TGA, Japan PAL, ISO 14971 and other applicable standards and regulations highly desired
  • Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE highly desired
  • Proven experience with lean manufacturing and six sigma processes 
  • Working knowledge of statistical packages (MiniTab) and design software (solid works)
  • Knowledge of cleanroom and terminal sterilization processes and requirements
  • Ability to clearly communicate and write reports and business correspondence in English. 
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.  
  • Ability to apply common sense understanding to carry out detailed written and/or oral instructions.
  • Ability to quickly assess large amounts of information and data.
  • Ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions.
  • Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to communicate effectively, and apply sound business judgment are important. 
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 and fingers to handle or feel objects. The employees frequently is required to sit, stand, walk, reach with hands and arms, and talk or hear and will occasionally be required to bend, stoop, kneel and climb stairs.
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.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
The noise level in the work environment is usually quiet to moderate.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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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.