Staff Systems Engineer

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Staff R&D Systems Engineer leads and/or supports all Systems Engineering aspects on new product development efforts within the Digital Unit (DU) organization.  The major responsibilities of the position are performing and overseeing others perform activities such as defining product requirements and associated specifications, making system architecture decisions, outlining design inputs, product design implementation, verification testing and supporting design validation studies. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background.  The Staff Systems Engineer is a subject matter expert (SME) and provides project and engineering leadership in all phases of complex med-device development, as well as ensures compliance to applicable Design Controls, Product Security, and Cybersecurity policies. The individual may serve as a core or extended team member on PRP/NPD projects. 

 

Areas of focus also include Systems aspects of identification of user needs, risk assessments as well as product and cybersecurity.

 

Extensive knowledge of medical device design control requirements, system design, software, hardware, digital image processing, integration 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.

Job Duties

• 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 Product Managers 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.

Job Qualifications

Required:

• Bachelor’s degree in Electrical, Software or Systems Engineering.
• Minimum years of related experience: 9+ years with a BS, or 8+ with MS or 5+ with PhD.
• Expertise in Developing complex medical systems that include hardware, software, systems and disposables/reusables.
• Expertise in FDA Des