Olympus Corporation of the Americas Principal Systems Engineer in Southborough, Massachusetts
Working Location: MASSACHUSETTS, SOUTHBOROUGH
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.
The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.
Extensive knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.
In a typical day, you will:
Provide project and technical leadership to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
Work closely with Marketing in collection of user needs/feedback on product requirements and concepts.
Lead the requirements development and management process, incorporating risk management elements as required.
Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
Support the optimization of design control elements to comply with medical device regulations.
Implement product design with the intention of optimizing design for manufacturability and testability.
Consider Cost of Goods and lifecycle when selecting components for device designs.
Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
Provide support of Risk Management activities, working with Design Assurance.
Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities.
Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas
Bachelor’s degree in Engineering or the equivalent in years of industry experience.
Minimum years of related experience: 9 years with a bachelor's degree or 8 years with MS or 5 years with PhD.
Expertise in FDA Design Controls and systems development of medical devices.
Experience in statistical analysis package (Stat Ease, Minitab) preferred.
Proficient with the creation and critical review of engineering drawing and specification documentation.
Proficient in requirements management.
Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
Working knowledge of software lifecycle management in compliance to EN62304. Ability to evaluate software and software documents and provide effective feedback to development partners.
Proficient in Microsoft Windows environment including Outlook, Excel, Word and Project.
Must be able to solve complex problems and provide guidance to other engineers.
Must be able to work with ambiguity and use good judgement in making decisions. Able to balance risk and opportunities.
Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.
Must be able to manage resources and drive for results, effectively managing projects and timelines.
Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
Inspires and motivates others and provides work direction.
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 at https://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) || Southborough ||