Senior R&D Systems Engineer
Working Location:
MASSACHUSETTS, WESTBOROUGH
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Job Description
The Senior R&D Systems Engineer will 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 engineer with a strong systems design and integration background. The primary responsibilities of this role will include support of all phases of device development with a focus on electrical and hardware engineering and firmware engineering. Within a collaborative team environment, it will be expected that he or she will be a proactive communicator, collaborate well with others, manage their work efficiently, produce high quality work and consistently seek additional knowledge and skills. Creation of product requirements, technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate Design History File deliverables. The successful candidate must have working knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability are required.
Job Duties
Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
Work with internal and external design partners to advance design efforts.
Provide design guidance relating to hardware and software(firmware) design.
Participate in creation and revision of requirements ensuring traceability to User Needs and test cases.
Support the requirements development and management process, incorporating risk management elements as required.
Support the creation 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 verification and validation testing strategies, authors test protocols and reports, and ensures products meet and/or exceed established specifications.
Utilize statistically sound approaches to design verification protocols/reports, design validation, and delivery system qualification activities.
Support 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.
Provides regular updates to engineering and marketing leadership on product status and advancement.
Supports leadership as required.
All additional duties as directed.
Job Requirements
REQUIRED
Qualifications:
Bachelor s degree in Electrical or Software Engineering.
Minimum years of related
Experience:
5 years or 4 years with MS or 2 with PhD.
PREFERRED
Qualifications:
Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in hand held electro-mechanical devices is preferred.
Must have working knowledge of ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
Capable of creation of design control deliverables and input to the Design History file either independently or under the guidance of the project technical lead.
Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.
Knowledge of printed circuit board design and manufacturing processes. Experienced in developing schematics, selection of components, and current knowledge of developments in the electronics industry.
Working knowledge of printed circuit board design tools (e.g., Altium, OrCAD) and capability to evaluate and scrutinize designs and Gerber data.
Knowledge of software lifecycle management in compliance to EN62304.
Experience problem solving system design issues (e.g., electromagnetic compatibility).
Ability to effectively work within a requirements management system, such as Doors, JAMA, etc and perform hardware risk analyses and hardware DFMEAs.
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
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Estimated Salary: $20 to $28 per hour based on qualifications.
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