Olympus America Inc. Design Assurance Engineer I in Bartlett, Tennessee
Bartlett, TN - The Design Assurance Engineer I is responsible for contributing to the design, development and management of projects for legacy products and support of new products under development. The Design Assurance Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Design Assurance Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
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Assist in the design & execution of Production Release Process (PRP) project for components & finished devices.
Lead and implement non-complex projects including quality improvement initiatives.
Demonstrate knowledge of basic statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
Demonstrate project management skills and interact with cross- functional teams. Working knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA).
Support Process/Design Risk Analysis.
Demonstrate working knowledge of Post Market Surveillance.
Utilize knowledge of Quality Engineering principles and methodologies.
Coordinate metrology support as needed, including gage R&R.
Maintain knowledge of Design Controls, CAPA, NC, etc.
Provide leadership in understanding of the regulations to other disciplines.
Support and lead product Design Control activities for new product development efforts.
Support Process/Design Validation/Verification activities and approach including software validation.
Assist in implementing cost of quality concepts, including cost of quality, data collection, & reporting.
Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in- house / external manufacturing.
Conduct Internal Audits of the Quality System.
Conduct audits of new suppliers as part of the project teams.
Communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Sales, Supply Chain and Marketing in order to provide quality input.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Perform other related duties as assigned by management.
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor’s Degree in Engineering is required.
0-2 years of experience in process quality engineering with an emphasis on Supplier Quality Management within an FDA regulated medical device manufacturing environment is required.
Proficiency with DMAIC / Black Belt / Six Sigma type tools to analyse, drive root cause, and solve problems is essential.
Working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab is desired.
Strong written and oral communication skills are required.
Proficiency with process trouble shooting of parts utilizing injection and insert molding, extrusion, stamping, wire EDM, and CNC machining is a must.
Understanding of the design, development, and tolerancing of complex systems is necessary.
Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, & ISO 11135 is necessary.
Must be self-motivated with a strong sense of urgency.
Proficiency in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM is a necessity.
Must have interaction to some degree with almost every department in the company.
Most often interacts with upstream marketing, quality assurance, research & development, regulatory, and manufacturing.
Some contact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel is essential.
Must possess direct work experience with manufacturing and research & development engineering in fabrication of prototypes for new product, modifications, and/or improvements.
The ability to work with manufacturing personnel in implementation of new products is essential.
The ability to work with marketing on design of new products is desired.
Must be able to manipulate microsize components with fingers.
Requires use of hands and arms to operate computer, printer, telephone, and develop drawings.
Requires ability to use magnifying devices and microscopes.
Auto req ID 2748BR
Posting Title Design Assurance Engineer I
Company URL Gyrus ACMI at http://www.gyrusacmi.com/
About Us Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Gyrus ACMI at http://www.gyrusacmi.com/
Posting Locations Tennessee, Bartlett
Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.