Olympus Corporation of the Americas Principal Engineer, Design Control & Process Excellence in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH
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The Principal Engineer Design Control/Process Excellence is responsible for owning and maintaining the R&D portion of the design control system. This role requires a deep understanding of design control systems, tools, applicable regulations and standards, as well as significant experience working in medical device development systems. The role is responsible for collaborating with functional managers and engineers in R&D, Quality, Manufacturing and Regulatory, among others, to ensure our design control procedures are relevant, clear and easy to use. The Principal Engineer Design Control/Process Excellence will continuously work to optimize our Design Control system by soliciting the product development community for problem areas, prioritizing the issues and collaborating with stakeholders to implement mitigations. This position will work with Regulatory and Quality to implement changes when new regulatory guidelines, or applicable standards, are issued that affect product development. The Principal Engineer Design Control/Process Excellence must be a clear and effective communicator who enjoys systems refinement, cross-functional collaboration, and teaching others. The Principal Engineer must also be comfortable negotiating collaborative solutions, envisioning new or enhanced processes and tools to help enable our product development teams achieve greater efficiency, and envision how changes or updates impact holistic system of procedures and tools, and feel comfortable presenting to cross-functional groups at all levels. As a subject matter expert, they will be expected to create training on Olympus’ Design Control system, present materials to product development engineers and will be available as a coach and advisor the product development teams addressing any questions that come up concerning the interpretation or application of the Design Control system.
Accountable for maintaining R&D design control procedures and for continuously optimizing content for clarity, usability and compliance.
Acts as the subject matter expert on design control for R&D, provides guidance to product development teams on the interpretation or application of design control procedures.
Collaborates with functional managers and engineers to ensure our design control procedures are relevant, clear and easy to use.
Seeks input from the product development community on design control problem areas, prioritizing the issues and collaborating with stakeholders to implement mitigations.
Works with Regulatory and Quality to implement changes when new regulatory guidelines or applicable standards are issued that affect product development.
Leads cross-functional training on Design Control in collaboration with Quality and Project Management.
Negotiates and seeks alignment with cross-functional leaders, where appropriate, with the implementation of new or updates to SOPs, forms or processes.
Seeks to ideate enhancements to our systems and processes with the ultimate goal of increasing product development efficiency, communication, and/or quality.
Leads cross-functional reoccurring meetings to ensure advancement of cross-functional enhancement efforts, collaboration on the creation of new systems.
Implements methods to ensure appropriate training is assigned to new hires, onboarding process is formalized for new R&D engineers, updated as appropriate.
Creates systems to ensure all updates/changes are communicated across US Development Center sites/employees.
Stays well informed on industry best practices for design control for medical device product development as it applies to R&D, meets regularly with Regulatory and Quality to align on best practices/changes to industry guidelines.
Bachelor’s degree in Mechanical Engineering or similar.
Minimum years of related experience: 9+ years, or 8+ years with Master's, or 5+ with PhD.
Extensive experience in leading medical device technical development efforts, through all phases of product development, demonstrated through several product life cycles, is required.
Experience developing products through a Phase Gate process as a technical Core Team member is required.
Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.
Extensive experience applying design control procedures to medical device development is required. Preferably, candidate will have experience developing products in multiple systems and can draw on extensive experience.
Experience developing disposable medical devices required.
Knowledge of common manufacturing methods, such as: injection molding and molded part design, extrusion, adhesives, ultrasonic welding, etc., as well as experience designing/developing products employing common medical device polymers is required.
Proficient in the critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is required. Working knowledge of Solidworks is a plus.
Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred).
Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations.
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 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 ||
Olympus Corporation of the Americas
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