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Senior Quality Engineer, Human Factors

Company: Olympus Corporation of the Americas
Location: Westborough
Posted on: March 17, 2023

Job Description:

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.
Let's inspire healthier lives, together.
Job Description
The 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 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.
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.

  • 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 basic project management skills and interact with cross-functional teams.

  • Knowledge of risk assessment tools (e.g., ISO 14971, FMEAs, FTA).

  • Lead Process/Design Risk Analysis.

  • Working knowledge of Post Market Surveillance.

  • In-depth knowledge of Quality Engineering principles and methodologies. In-depth knowledge of Design Controls, CAPA, NC, etc.

  • Coordinate and lead metrology support as needed, including gage R&R.

  • Provide leadership in understanding of the quality regulations to other disciplines.

  • Support and lead multiple product Design Control activities for new product development efforts. Support Process/Design Validation/Verification activities and approach including software validation.

  • Lead implementing limited 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 inhouse / 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.

    Job Requirements

    • Bachelor's Degree in Engineering required.

    • Minimum of 2-4 years (minimum of 2 years with Masters Degree) years of experience in process quality engineering with an emphasis on Supplier Quality Management within an FDA regulated medical device manufacturing environment.

    • Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.

    • Knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.

    • Knowledge with process trouble shooting of parts utilizing injection and insert molding, extrusion, stamping, wire EDM, and CNC machining.

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

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

    • Internal: Must interact to some degree with almost every department in the company. Most often interacts with upstream marketing, quality assurance, research & development, regulatory, and manufacturing.

    • External: Some contact with customers, consultants, surgeons, product users, patients, and suppliers, including domestic and international travel.

    • For Organization Influence: Work 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. Work with marketing on design of new products

    • Must be able to manipulate micro-size 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 micro-size components, as well as, use of magnifying devices and microscopes.

    • Requires visual ability to withstand hours of computer work.


      • Strong written and oral communication skills are required.

      • Self-motivated with a strong sense of urgency.

      • Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.

        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.
        Olympus requires all new hires to be "fully vaccinated" against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
        Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
        Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .
        Olympus---True To You. True To Society. True To LIFE.
        It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
        Posting Notes: -- United States (US) -- Massachusetts (US-MA) -- Westborough --

Keywords: Olympus Corporation of the Americas, Worcester , Senior Quality Engineer, Human Factors, Engineering , Westborough, Massachusetts

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