Olympus Corporation · 19 hours ago
Staff Systems Engineer
Greater Boston
Full-time
Hybrid
Senior Level, Lead/Staff
$120K/yr - $168K/yr
9+ years expOlympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. The Staff Systems Engineer will lead and support Systems Engineering aspects on new product development efforts, ensuring compliance with design controls and cybersecurity policies while providing technical leadership throughout the product lifecycle.
ElectronicsIndustrialManufacturingMedical DeviceProduct Design
Responsibilities
Provide project and technical leadership as it relates to Systems 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
Provide leadership on detailed design, requirements, architecture and data analysis
Experienced in developing User and Product Requirements
Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and applicable standards
Capable of effectively communicating with Core Team and Extended Team Members, while ensuring all R&D deliverables are completed with a high degree of quality, and attention to detail
Collaborates on the development of the technical development schedule and monitors
Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance. (IEC81001-5-1, IEC62304)
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
Experienced in providing technical updates to systems leadership, and/or to an R&D Core Team Member, through weekly discussions and monthly updates
Capable of prioritizing and organizing work/efforts based on project priorities
Experienced in supporting robust design analysis, such as tolerance stack-ups, edge of failure testing, high/low specification evaluations, risk analysis, and statistical evaluations as necessary to ensure performance and quality
Proactively ideates and leads technical risk reduction activities and contingency planning
Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions
Manages, directs, and supports suppliers involved in product development and ongoing production, including external design and development partners
Qualification
Required
Bachelor's degree in Mechanical Engineering or similar
Minimum years of related experience: 9 years with BS, 8 years with MS, 5 with PhD
Competency in leading medical device technical development efforts, through all phases of product development, is required
Experience developing disposable medical devices 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
Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc
Self-motivated, engaged, and productive
Proficient in the creation and critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is 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
Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking. Capable of providing problem solving guidance to other engineers
Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations
Must be able to envision design failure modes, plan for robust design assurance testing, and proactively implement contingency plans as necessary
Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred)
Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable
Must be able to drive for results
Must be able to communicate effectively at all levels, both verbally and in writing
Strong presentation skills and the ability to influence
Able to predict and manage the expectations of project stakeholders
Inspires and motivates others and provides work direction
A positive “Can Do” attitude
Preferred
Experience developing products through a Phase Gate process as a Core Team member is highly preferred
Experience and or working knowledge of developing capital equipment is desired
Working knowledge of Solidworks is a plus
Benefits
Competitive salaries, annual bonus and 401(k) with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center
Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
Company
Olympus Corporation
Olympus is passionate about creating customer-driven solutions for the medical industry.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Yasuo Takeuchi
Executive Chairman
Recent News
2025-05-27
2025-05-19
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