Design Assurance Engineer in Thousand Oaks, California at Implant Direct

Date Posted: 2/8/2018

Job Snapshot

Job Description

Job ID: IMP000513

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 leading projects and activities to assure quality is designed in to the new product and in the Lifecycle Management.  With comprehensive knowledge of engineering and problem solving principles, he/she will apply “Good Engineering Practices” that will not only meet regulations and standards but exceed customer satisfaction.  The incumbent for this position will complete various engineering support duties including, (but not limited to), design verification and validations, test method validations, process validations, software validations, equipment qualifications IQ/OQ/PQ, 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.
  • 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.
  • Lead 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.
  • Develops or participates in establishing requirements for all verification and validation (design and process) activities.
  • Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes.
  • Leads development of Risk Management documentation.
  • Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
  • Participates in audits and inspections of the company and our quality systems.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:  To perform this 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 functions.


REQUIRED EDUCATION AND/OR EXPERIENCE:
  • Bachelor of Science in Engineering or related Engineering field required.
  • Minimum 2 years in QE role in product design and development, preferably in a Class II or III medical device environment.
  • 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. 
  • Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE.  Working knowledge of statistical packages (MiniTab) and design software (solid works) preferred.
PREFERRED SKILLS:
  • Master degree
  • Regulatory Affairs Certification (RAC) or CQE (Certified Quality Engineer) preferred
  • Proven experience with lean manufacturing and six sigma processes 
  • Experience related to the regulation of Class II and III medical devices
  • Knowledge of cleanroom and terminal sterilization processes and requirements

LANGUAGE SKILLS: 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.  

REASONING ABILITY:  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. The 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.

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Implant Direct offers competitive compensation and a generous benefits package. Benefits include: Medical and dental, vision insurance, 401(k) plan with employer match, group term life & AD&D, Flexible Spending Account, Employee Assistance Program, Flexible Spending Accounts, and paid vacation and holidays. Please visit our website at www.implantdirect.com for more information about our innovative company. 


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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