Systems Engineer

Mainstay Medical International plc; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Mainstay Medical in San Diego is seeking a Systems Engineer to support the Product Development group, spanning mechanical, electrical, software and biomedical engineering with a regulated development program.

You will collaborate with Engineering, Regulatory/Quality and Marketing to translate stakeholder needs into system requirements, lead design reviews, manage risk, and ensure traceability from concept to launch in line with FDA MDR guidance and ISO 14971.

Qualifications

• Minimum 2 years experience as a Systems Engineer, Validation/Test Engineer or related role under a regulated medical device environment.
• Bachelor's degree in Biomedical, Systems, Mechanical, Electrical, Software, Controls, or other technically relevant field.
• Demonstrated ability to work cohesively with cross-functional team members to meet common engineering and product development goals.
• Strong written and verbal communication skills in an engineering and product development environment.
• Familiarity with FDA design controls guidance.
• Knowledge of Risk Management processes following ISO 14971.
• The ability to quickly learn complicated new systems, accurately describe and diagram those systems, and verbally explain their intricacies and interfaces to a variety of audiences with different technical or non-technical backgrounds.

Responsibilities

• Collaborate with fellow engineers in the Product Development group as well as partners in Quality, Regulatory and Marketing to support project execution through various phases of the product development life cycle.
• Leverage your background in biomedical, systems, software, and/or other engineering fields to support the execution of design control activities and tasks for existing products and new products from concept to launch.
• Be responsible for eliciting stakeholder needs, goals and objectives and translate them into formal customer, clinical, regulatory, and business requirements.
• Decompose high level stakeholder needs into singular, testable, unambiguous, necessary, feasible, complete, and consistent system and subsystem requirements.
• Support risk management activities by following ISO 14971 and similar processes.
• Lead design reviews and verification/validation and related activities including planning, resource allocation, protocol creation, test execution and documentation.
• Review technical decisions and design strategy for alignment with stakeholder needs, risk minimization, and prevention of subsystem-interface conflicts. Identify tradeoffs of potential design decisions and convey the risks and benefits of those decisions.
• Support human factors/usability activities according to FDA and MDR guidance and recognized consensus standards.
• Ensure all stakeholder needs, requirements, and risk controls are satisfied; and traceability is properly documented.
• Create and maintain design history files.
• Analyze proposed changes to products and provide a detailed impact analysis to ensure successful and predictable implementation.
• Support and lead failure investigations including root cause analysis and associated CAPA activities. Participate in troubleshooting issues during product development and post product release.
• Complete other related duties as assigned.

Skills

Systems engineering

Regulatory knowledge

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in Biomedical/Systems/Mechanical/Electrical/Software

Tools

Doors

Polarian

Jama

Matrix

Python

LabVIEW

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Salary Range: $90,000.00 To $120,000.00 Annually

This position is onsite in San Diego.

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 the United States, Australia, the United Kingdom, and Germany.

The Role:

The 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 Systems Engineer is primarily responsible for successfully supporting projects through a structured and regulated product development program, working closely with other functional leads in Engineering, Regulatory/Quality and Marketing.

Position Responsibilities:

• Collaborate with fellow engineers in the Product Development group as well as partners in Quality, Regulatory and Marketing to support project execution through various phases of the product development life cycle.
• Leverage your background in biomedical, systems, software, and/or other engineering fields to support the execution of design control activities and tasks for existing products and new products from concept to launch.
• Be responsible for eliciting stakeholder needs, goals and objectives and translate them into formal customer, clinical, regulatory, and business requirements.
• Decompose high level stakeholder needs into singular, testable, unambiguous, necessary, feasible, complete, and consistent system and subsystem requirements.
• Support risk management activities by following ISO 14971 and similar processes.
• Lead design reviews and verification/validation and related activities including planning, resource allocation, protocol creation, test execution and documentation.
• Review technical decisions and design strategy for alignment with stakeholder needs, risk minimization, and prevention of subsystem-interface conflicts. Identify tradeoffs of potential design decisions and convey the risks and benefits of those decisions.
• Support human factors/usability activities according to FDA and MDR guidance and recognized consensus standards.
• Ensure all stakeholder needs, requirements, and risk controls are satisfied; and traceability is properly documented.
• Create and maintain design history files.
• Analyze proposed changes to products and provide a detailed impact analysis to ensure successful and predictable implementation.
• Support and lead failure investigations including root cause analysis and associated CAPA activities. Participate in troubleshooting issues during product development and post product release.
• Complete other related duties as assigned.

Minimum Qualifications:

• Minimum 2 years experience as a Systems Engineer, Validation/Test Engineer or related role under a regulated medical device environment.
• Minimum Bachelors degree in Biomedical, Systems, Mechanical, Electrical, Software, Controls, or other technically relevant field.
• Demonstrated ability to work cohesively with cross-functional team members to meet common engineering and product development goals.
• Strong written and verbal communication skills in an engineering and product development environment.
• Familiarity with FDA design controls guidance.
• Knowledge of Risk Management processes following ISO 14971.
• The ability to quickly learn complicated new systems, accurately describe and diagram those systems, and verbally explain their intricacies and interfaces to a variety of audiences with different technical or non-technical backgrounds.

Preferred Qualifications:

• Demonstrated success applying formal Systems Engineering principles and Systems thinking to Engineering and Product Development projects.
• Experience working with FDA Class III or EU MDR Class III devices.
• Previous experience with the following additional standards and regulations: EU MDR, TGA EP, UK AIMDD, IEC 60601-1 series, IEC 62304, IEC 62366-1, IEC 20417, ISO 10993, ISO 10974, ISO 11607, ISO 14708-1 / EN 45502-1, AAMI TIR57, 21 CFR 15, RoHS, REACH, EU RED, ETSI series, and AS/NZS 4268.
• Familiarity with one or more software tools for the management of requirements, (product/project) risks, verification, validation, etc. (e.g., Doors, Polarian, Jama, Matrix).
• Familiarity with INCOSE and NASA Systems Engineering Handbook.
• Competent in a programming/scripting language for use in automating data processing, test execution, reporting, and other related activities (e.g, Python, Matlab, VB for Excel, Labview, etc).
• Experience designing, building, reviewing, and validating fixtures to support testing.
• Familiarity with the FDA’s cybersecurity guidance, risk management approach, and cybersecurity testing.
• Software Development and/or Software Testing knowledge and skills, including use of revision control systems.

The salary range for this position is $90,000 to $120,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.