Biomedical Systems Engineer – Medical Device Product Development

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

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.