Sr. Product Development Engineer
Company: Envista Holdings
Location: Thousand Oaks
Posted on: January 10, 2022
Implant Direct is part of Envista's portfolio of dental product
and service companies, including more than 30 trusted brands and
over 125 years of dental excellence. With over 4.6 million implants
placed worldwide, Implant Direct enables dentists to advance their
patients' oral health with high-quality dental implant solutions.
All implants are manufactured in the USA using only medical-grade
titanium alloy, meeting the industry's highest performance and
safety standards. We offer a unique portfolio of products and
solutions that elevate the performance of your practice through
predictable outcomes, greater patient satisfaction, and reduced
total costs. We are committed to renewing confidence and changing
lives through enhancing patient access. For more information about
Implant Direct, visit www.Implantdirect.com
Job Description:Job Summary:The Sr. Product Development Engineer is
engaged in executing the main elements of New Product Development
to introduce surgical implants, prosthetics, and instruments to
market. In this role, you will participate in Concept Development,
Design & Development, Design Verification & Validation, and Design
Transfer. You will serve as a core team member of the Design
Engineering team working independently with minimal guidance, while
partnering with cross-functional experts on projects. You will
participate in the planning and execution of project team leader
activities related to Design Verification & Validation activities
including product & packaging performance evaluation,
Biocompatibility assessment, Usability Studies and Sterilization
Validation assessment.Essential Duties:
- Perform project team leader activities to design and develop
- Generate product development documentation ensuring compliance
with internal operating procedures, ISO 13485 and FDA 21CFR Part
- Create various elements of the Design History File and
Technical File, using Design Control.
- Participate in the following Design Control activities: Design
and Development Plan, Design Input, Design Output (e.g. engineering
drawings, specifications, labels, packaging), Design Verification
and Validation (e.g. write protocol, perform testing, write test
report, write engineering rationale), and Design Transfer.
- Conduct risk management activities and document results
ensuring compliance with internal procedures and ISO-14971.
- Conduct biocompatibility evaluations and generate documentation
ensuring compliance with internal procedures and ISO 10993-1.
- Perform Finite Element Analysis.
- Perform statistical analysis for test results and sample size
- Partner with cross-functional Core Team Members to drive the
project through completion; perform project management tasks
- Generate documentation of Technical Files per CE Marking
- Review dimensions of parts, materials to be used, relations of
one part to another, and relation of various parts to whole
structure of product lines.
- Review and approve drawings, applying knowledge and experience
utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME
- Acts a knowledgeable resource for colleagues and team
- Bachelor's degree in Mechanical Engineering (preferred) or
Biomedical Engineering with minimum 6 years' experience in product
development activities of medical devices, or
- Master's degree in Mechanical Engineering (preferred) or
Biomedical Engineering and minimum 4 years' experience in product
development activities of medical devices
- Experience in new product development of medical devices.
- Proficient in 3D CAD modeling and Engineering Drawings
- Experienced with Design Control and Risk Management per 21 CFR
Part 820, ISO 13485, ISO 14971
- Knowledge of ISO 10993 for Biological Evaluation and ISO 11737
- Knowledge of Usability Engineering per IEC 62366-1
- Strong technical writing skills and experience writing product
requirements, specifications, test protocols and test reports, and
engineering rationales.#LI-PB1IND123Operating Company:Implant
DirectEnvista and all Envista 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.
Keywords: Envista Holdings, Thousand Oaks , Sr. Product Development Engineer, Engineering , Thousand Oaks, California
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