The R&D Sustaining Engineer will provide technical support on all existing product designs for Ormco's Bracket and Wire business. The R&D Sustaining team works in a collaborative environment with cross-functional partners (i.e. Product Management, Quality, Regulatory, Operations, and Procurement) to maintain the quality of the finished product, ensure timely delivery of our product, maintain global registrations, improve the efficiency of our processes, and improve our cost position on the product.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Investigate and assess design history files (DHF), CE Tech Files, design specifications, test reports and manufacturing documentation to identify and resolve technical gaps and provide accurate and timely technical information for Regulatory submissions.
- Work closely with subject matter experts to development technical justification reports.
- Create performance verification protocols and write reports.
- Execute test protocols, summarize data, analyze and make conclusions.
- Prepare product drawings and illustrations for Regulatory submission.
- Attend appropriate meetings – technical and core team, providing updates as required.
- Create and/or modify product design, product performance specifications, drawings, procedures, CAD models (SolidWorks).
- Create and execute Engineering Change Requests (ECR) in accordance with internal quality system procedures.
- Conduct product testing, field failure root cause investigations and develop, verify, validate and implement solutions in accordance with internal quality system procedures.
- Represent R&D Sustaining as a cross functional team member in support of product development, quality, manufacturing, customer service, sales, marketing, regulatory affairs and procurement department objectives.
- Bachelor's in Engineering required. BS in Mechanical or Materials Engineering preferred.
- 3-4 years relevant sustaining engineering experience required; preferably medical device product development and/or manufacturing environment preferred.
- Experience with mechanical characterization methods such as tensile, compression or modulus testing preferred.
- FDA Quality System Regulation Part 820 and ISO 13485 experience preferred.
- Working knowledge of SolidWorks CAD software is preferred.
- Ability to read, analyze, interpret, create, and meet: product specifications, technical procedures and worldwide governmental regulations.
- Ability to develop test protocols, execute testing, statistically analyze data, and develop conclusions.
- Ability to write technical reports and justifications.
- Excellent interpersonal skills and ability work well within a team and collaborate with and influence others.
- Excellent oral and written communication skills.
Envista 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.
- Requisition ID: ORM00199
- Posting Date: Feb 13, 2020
- Remote Location: No