Olympus America Inc. Principal Design Assurance Engineer in Brooklyn Park, Minnesota
Bachelor’s Degree in Engineering.
Minimum of 10 years of experience in process quality engineering with an emphasis on Design Quality and Risk Management within an FDA regulated medical device manufacturing environment.
Proficiency with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
In-depth knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
Strong written and oral communication skills are required.
In-depth of the design, development, and tolerancing of complex systems.
Proficient 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.
Expert knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, Gage 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.
Expert knowledge of Risk Management tools (e.g., ISO 14971, FMEA#s, FTA, I.S EN 62366).
Expert knowledge of Test Method Validations (TMV).
In-depth knowledge of Post Market Surveillance.
Proficient knowledge of Quality Engineering principles and methodologies.
Proficient knowledge of Design Controls, CAPA, NC, etc.
Ability to 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.
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.
Ability to interact to some degree with almost every department in the company; most often interacts with upstream marketing, quality assurance, research & development, regulatory, and manufacturing.
Ability to interact externally with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel.
Ability to manipulate microsize components with fingers. Requires use of hands and arms to operate computer, printer, telephone, and develop drawings. Requires the ability to communicate on a telephone. Requires ability to see miniature and microsize components, as well as, use of magnifying devices and microscopes. Requires visual ability to withstand hours of computer work.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
As a Principal Design Assurance Quality Engineer working on the OSTA Design Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by providing our customers with the highest level quality product that will be functional, safe, Effective, and reliable. A typical day for you will include:
*Test Method Qualification/Validation
*Cascading of CtQ’s to manufacturing
Assisting in the design & execution of Product Development Process (PDP) for all OSTA design or distributed products.
Leading and implementing complex projects including quality improvement initiatives.
Supporting and leading product Design Control activities for new product development efforts.
Supporting Process/Design Validation/Verification activities and approach including software validation.
Assisting in implementing cost of quality concepts, including cost of quality, data collection, & reporting.
Providing leadership in understanding of the regulations to other disciplines within and outside the organization.
Supporting Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in- house/external manufacturing.
Working directly with manufacturing and research & development engineering in fabrication of prototypes for new product, modifications, and/or improvements. Work with manufacturing personnel in implementation of new products.
Working with marketing on design of new products.
Conducting Internal and/or External Audits of the Quality System.
Communicating effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Sales, Supply Chain, Regulatory, and Marketing in order to provide quality input.
Maintaining responsibility for providing project direction, coaching, mentoring and supervision for design assurance quality engineers and/or technical team personnel.
Performing other related duties as assigned by management.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
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
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. We’re currently looking for a Principal Design Assurance Engineer to join us in our Brooklyn Park, MN office.
Let’s inspire healthier lives, together.
The Principal 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 supports 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, Regulatory and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
Olympus Surgical Technology America at http://www.olympus-osta.com/
Principal Design Assurance Engineer
Minnesota, Brooklyn Park
Brooklyn Park GYR ACMI LP
Auto req ID:
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.