- Design Controls
- Writing Skills
- Certified Quality Engineer
- Data Collection
JOB DESCRIPTION: Sr. Design Assurance Engineer will be responsible for leading complex 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. This role is based in Orange, CA and works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
PRIMARY DUTIES & RESPONSIBILITIES:
Actively participates in defining customer requirement, product claims and target markets early in the product development life cycle.
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-conformance and investigations to determine root cause, corrective and preventive actions.
Mentors junior Design Assurance Engineers as required.
Participates in audits and inspections of the company and our quality systems.
Bachelor’s degree in an engineering, life sciences, quality assurance or similar discipline.
5+ years in an FDA regulated industry in product design and development or manufacturing, medical device experience preferred.
Solid understanding of design controls and risk management (ISO 13485, 21 CFR 820 and ISO 14971).
Proficient in Statistical analytics, Advanced SPC, Quality Analysis Tools and DOE.
CQE (Certified Quality Engineer) preferred.
Ability to perform independently and as part of a team.
Must be able to influence & negotiate with people & resolve issues.
Ability to make rational, objective & appropriate decisions relating to Design Assurance
Ability to identify customer needs & issues & develop realistic solutions to meet needs & solve problems.
Ability to communicate decisions across a wide spectrum of the organization.
Effective writing 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. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Requisition ID: KAV00100
Posting Date: Nov 7, 2019
Remote Location: No