Olympus America Inc. Sr. Design Assurance Engineer in Brooklyn Park, Minnesota

Job Description

Brooklyn Park, MN - The Senior Design Assurance Engineer is responsible for contributing to the design, development and management of projects for legacy products and support of new products under development. The incumbent provides organizational support with a focus on Design Quality activities. He/She 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 incumbent 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. EOE M/F/D/V

Job Duties:

  • Assist in the design & execution of Production Release Process (PRP) project for components & finished devices.

  • Lead and implement complex projects including quality improvement initiatives.

  • Maintain working knowledge of advanced 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 and collaborate with cross-functional teams.

  • Maintain in-depth knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA, I.S EN 62366).

  • Support Process Risk Analysis. In-depth knowledge of Post Market Surveillance.

  • Maintain in-depth knowledge of Quality Engineering principles and methodologies.

  • Maintain in-depth 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. Perform other related duties as assigned by management.

  • 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 all other essential duties as assigned.

Job Requirements:

(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

  • Bachelor’s Degree in Engineering is required.

  • Minimum of 7 years of experience in process quality engineering with an emphasis on Design Quality and Risk 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.

  • In-depth knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab is preferred.

  • Understanding of the design, development, and tolerancing of complex systems is desired.

  • Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, I.S EN 62366, & ISO 11135 is essential.

  • Must be able to interact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel.

  • Must be able to work in a cross-functional team environment with Marketing, manufacturing and research & development for new products, modifications, and/or improvements.

Auto req ID 2178BR

Posting Title Sr. Design Assurance Engineer

Company URL Olympus Surgical Technology America at http://www.olympus-osta.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. Olympus Surgical Technology America

Posting Locations Minnesota, Brooklyn Park

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.