Staff Systems Engineer Job Details | Olympus Corporation of the Americas
Olympus
Optoelectronic Equipment
Westborough, MA - USA
Senior Specialist / Project Manager
Experteer Overview
As Staff Systems Engineer, you lead and support systems engineering across new product development in Olympus Surgical Technologies of America. You will shape system requirements, architecture, and verification strategies for NPD efforts, ensuring medical device design controls and cybersecurity policies are met. You’ll work with cross-functional teams to balance risk, cost, and user needs while driving DTO and regulatory compliance. This role offers impact by shaping complex med-device solutions and advancing patient care through robust design and collaboration.
Compensation / Benefits
- Competitive salaries
- 401(k) with company match
- Comprehensive medical, dental, vision coverage
- Paid time off and holidays
- Parental leave and adoption assistance
- On-site amenities and Wellbeing programs
Responsibilities
- Provide technical and project leadership for systems engineering across cross-functional teams and external partners from concept to commercialization
- Develop and manage system, sub-system, and software requirements with traceability and risk elements
- Lead design inputs, architecture decisions, and design verification/validation planning
- Collaborate with Marketing to capture user needs and translate them into product requirements
- Ensure compliance with medical device regulations and cyber security policies (IEC standards), including design controls
- Oversee design for manufacturability and testability and cost of goods considerations
- Develop and review engineering drawings, tolerances, and manufacturing methods (e.g., injection molding, extrusion, adhesives, ultrasonic welding)
- Lead risk management activities and statistical analyses; support design assurance and standardized testing
- Manage supplier relationships and external development partners
- Communicate progress and technical updates to leadership and core teams; drive contingency planning
Key requirements
- Bachelor's degree in Mechanical Engineering
- 9 years with BS / 8 years with MS / 5 years with PhD in medical device technical development
- Experience leading medical device development through all phases
- Experience developing disposable medical devices
- Knowledge of FDA/international regulations (FDA 820-CFR, ISO-13485, IEC60601, QSR)
- Proficient with Windows Office suite; strong engineering drawing and GD&T capabilities
- Knowledge of manufacturing methods (injection molding, extrusion, adhesives, ultrasonic welding) and medical polymers
- Statistical methods experience; proficiency with statistics software (Minitab preferred)
- Strong communication and cross-functional collaboration skills
- Ability to prioritize, manage risk, and provide technical leadership
Description
As Staff Systems Engineer, you lead and support systems engineering across new product development in Olympus Surgical Technologies of Ameri…
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