Senior System Engineer, R&D (Medical Devices) Hybrid

How will you make an impact?

We are seeking a highly skilled, self-motivated and experienced Senior System Engineer to join our R&D team. The successful candidate will play a key role to ensure the design, development, and functionality of devices meet regulatory standards and deliver safe, reliable solutions for healthcare providers and patients. The Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality. Core responsibilities include assisting with system level architecture/design and contributing to the implementation and V&V of complex electro-mechanical devices.

What will you do?

Product development

• Performs functional analysis, timeline analysis, and detailed concept studies to translate customer requirements into hardware and software solutions.
• Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts.
• Provide technical presentation support and consultation to marketing for proposals and during development.
• Work with cross-functional teams to ideate, develop and test subsystem concepts, and develop subsystem architectures.
• Ensure the design adheres to system requirements, such as usability, ergonomics, and power efficiency for medical applications.

Requirements Analysis and Specifications:

• Collaborate with cross-functional teams (e.g., clinical, regulatory, quality assurance, and R&D) to gather and analyze system requirements and Ensure traceability from requirements to design and V&V.
• Define system requirements and specifications based on Software, Electrical, Mechanical, Electro-optics, clinical needs, regulatory requirements (like FDA, ISO 13485), and user feed-back.
• Establishing, implementing, and upholding requirements management strategies, processes, and best practices.

System Integration:

• Support System Integration of hardware, software, and firmware components, Verification and Validation by defining, specifying and supervising testing, analysis and integration activities. En-sure reports are prepared to document the results of such activities.
• Understanding the full system performance and behavior to drive SMEs resolution during the development and integration.

Risk Management:

• Conduct hazard analysis and risk assessments (e.g., Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA)) to identify potential risks.
• Work to minimize risks through design controls, redundancy, and safety mechanisms.

Verification and Validation (V&V)

• Conduct testing on both the system and subsystem levels, including bench tests, simulations, and clinical evaluations, Engineering Prototypes etc.
• Work closely with quality assurance teams to document testing processes and ensure thorough validation.
  

Lifecycle and Change Management:

• Manage change orders through digital platforms such as Oracle and Veeva, ensuring accurate documentation and timely implementation.
• Collaborate with the team's product post launch to address any field issues, recalls, or design changes based on manufacturing and field feedback.
• Support field service team to create the service manuals and troubleshooting guides.

How will you get there?

• Bachelor's degree in electrical engineering or related field; advanced degree preferred.
• 5+ years of experience in system engineering within the medical device industry, with a focus on complex electro-mechanical devices.
• Ability to contribute to translating high level product requirements into system and sub- system level specifications and designs.
• Demonstrated success as an engineering team member in the architecture, system level de-sign, integration and verification of complex electro-mechanical devices.
• Experience of utilizing the requirement management tools such as Helix, Jama etc.
• Development experience in at least one or more of the following engineering disciplines is re-quired: software, mechanical, electrical, optics, and should possess knowledge of advanced theories, concepts, principles, and processes.
• Experience conducting usability studies and generating risk management files, including DFMEA preferred.
• Understanding of regulatory standards and requirements, particularly 60601-1, 60601-2, 60601-1-6 and other relevant compliance and safety standards, preferred.
• Understanding of Cybersecurity for medical devices such as ANSI/AAMI SW96, ISO 81001-1 etc. preferred.
• Ability to work effectively across different functions and with external partners to drive project success.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Detail-oriented with strong analytical and problem-solving abilities.

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.