Senior Systems Engineer

San Diego, CA        ·       Full time

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

The Role

Mainstay Medical is seeking a highly motivated Senior Systems Engineer who will support the Reactiv8 Implantable Neurostimulation System. This role will also make impactful contributions to new product development from concept to launch. The ideal candidate must adequately understand clinical use cases, act as a conduit for various stakeholder needs and thrive in a dynamic startup environment.  

The Senior Systems Engineer position is part of Mainstay Medical’s Product Development department.  Your contributions at Mainstay are at the intersection of mechanical, electrical, software and biomedical engineering and draws from principles from each discipline.  The Senior Systems Engineer is primarily responsible for successfully moving projects through a structured and regulated product development program, working closely with other functional leads in Engineering, Regulatory/Quality and Marketing.

Position Responsibilities

• Work with fellow engineers in the Product Development group as well as partners in Quality, Regulatory and Marketing to drive projects through various phases of the Product development life cycle.
• Use Biomedical, Systems, Software, and other engineering principles to lead the execution of Design Control Activities and tasks for existing products and new products from concept to launch.
• Elicit product stakeholder needs, goals and objectives and translate them into formal Customer, Clinical and Business Requirements.
• Define and document System Requirements and multi-disciplinary sub-system requirements (Mechanical, Electrical, Software and Firmware).  Coordinate with sub-system/functional leads to ensure that requirements are clear, complete, and testable.
• Identify, define, and document product requirements related to performance, regulatory compliance, safety compliance and cybersecurity.
• Create and maintain Design History Files.
• Lead Design Reviews and Verification/Validation and related activities including planning, resource allocation, protocol creation, test execution and documentation.
• Ensure all User Needs, Requirements and Risk Controls are satisfied, and traceability is properly documented.
• Analyze proposed changes to products and provide a detailed Impact Analysis to ensure successful and predictable implementation.
• Assess complex product requirements and characteristics for any gaps in Design Control requirements and/or regulatory and safety compliance.
• Create detailed project plans that meet Design Control SOP requirements.  Project plans must also demonstrate project management best practices that meet team expectations and help ensure project success and predictability.
• Communicate key information and recommendations to influence technical decisions and strategy.
• Support and lead failure investigations including root cause analysis and associated CAPA activities.  Participate in troubleshooting issues during product development and post product release.
• Lead/participate in Risk Management activities such as Hazard Analysis and FMEA.
• Support Human Factors/Usability activities according to FDA and MDR guidance and recognized consensus standards.
• Identify tradeoffs of potential design decisions and convey the risks and benefits of those decisions.
• Complete other related duties as assigned.

Competencies

• Teamwork – a self-starter with the ability to work with all functions within an organization.
• Integrity – execute engineering responsibilities ethically and handle confidential information in an effective manner. 
• Agile – able to switch gears when the business requires it. 
• Leadership – ability to lead by example. Establish credibility within the organization and lead others when warranted. 

Qualifications

• Minimum 2-3 years experience as a Systems Engineer, Validation/Test Engineer or related role under a medical device regulated environment (Class II minimum, Class III highly desired)
• Minimum Bachelors degree in Biomedical, Systems, Mechanical, Electrical or other technically relevant field.
• Highly competent in executing under a structured and rigorous product development program.
• Demonstrated ability to work cohesively with cross-functional team members to meet common engineering and product development goals.
• Working knowledge of Risk Management according to ISO 14971, or other standards-based Risk Management framework.
• Minimum general knowledge of IEC 60601-1 requirements and related standards, or similar standards-based safety frameworks.
• Highly competent in leading and performing activities and tasks according to IEC 62304 software life cycle processes or demonstrated ability to satisfy requirements of other software life cycle standards.
• Minimum general knowledge of IEC 62366-1, or similar.
• Strong written and verbal communication skills in an Engineering and Product Development environment.
• Competent in a programming/scripting language for use in automating data processing, test execution, reporting, and other related activities (e.g, Python, VB for Excel, Labview, etc)
• Familiar with ALM software tools for requirements management, test management etc (e.g., Doors, Polarian, Jama, etc).
• Highly desired: Professional experience in an FDA III environment
• Highly desired: Working knowledge of ISO 14708-1/EN 45502-1
• Highly desired: Cybersecurity according to recognized consensus standards and/or regulatory guidance
• Highly desired: FCC/wireless standards-based testing experience.
• Highly desired: Software Development and/or Software Testing knowledge and skills, including use of revision control systems.
• Highly desired: Demonstrated success applying formal Systems Engineering principles and Systems thinking to Engineering and Product Development projects, including common industry software tools. (e.g., MBSE, Incose, etc).

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle of feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 30% of the time and work after hours is required by travel schedule or business issues. 

We hope you will join us on this journey to ReActiv8 life! 

• Dr. David Lee gives a quick presentation and perform our implant procedure on a synthetic cadaver. Feel free to watch our segment on Vimeo: https://vimeo.com/647859001/448fb6da23
• Watch video testimonial from Mainstay Medical patients: https://mainstaymedical.com/patients/#testimonials

Come join a growing and thriving organization!  We foster an exciting culture founded on teamwork, bias for action, urgency, and accountability, which allow us to develop meaningful and lasting relationships with our colleagues, the Doctors and Patients we serve.

We offer a competitive package.  Our core benefits include Medical, Dental, Vision, 401(k) Retirement Savings, Life and Short-Term Disability, PTO.

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