Biomedical Engineer

StartupAZ Foundation; Scottsdale (AZ); On-site; USD 65,000 - 85,000; Full time

Job summary

Join a leading company in medical device innovation focused on improving lives. This full-time role in Scottsdale emphasizes integrated design of embedded software and electrical systems for neonatal health solutions. You'll collaborate with experts and drive forward-thinking technology while ensuring compliance with medical standards.

Benefits

401(k)

Dental insurance

Flexible schedule

Health insurance

Health savings account

Life insurance

Parental leave

Sick leave

Unlimited Vacation Time

Bonus pay and Stock Options

Qualifications

• Entry-level position preferred, 1-2 years experience in medical product development encouraged.
• Hands-on experience with C/C++ for embedded software development required.
• Familiarity with IEC 60601-1 medical electronics standards recommended.

Responsibilities

• Owning embedded software/firmware and electrical design for medical devices.
• Develop design requirements and test methodologies.
• Lead product verification and validation activities.

Skills

Reading engineering specifications

Electrical design debugging

Understanding electrical schematics

PCB design methodologies

Electrical debug tools usage

Statistical data analysis

Education

Bachelor's Degree in Electrical Engineering

Master's Degree (Preferred)

Tools

LTSPICE

CAD tools

Job description

Education:

• Bachelor's Degree in Electrical Engineering (Required) from an accredited university or college.
• A Master's degree is preferred.

Experience:

• This is an entry-level position. Therefore, no previous employment experience is necessary to apply. However, candidates with 1-2 years of experience in medical product development focused on their field study are highly encouraged to apply.

What You Will Do

• Owning embedded software/firmware and electrical design for commercialized products and helping with medical device product advancements.
• Understand end-user needs and system requirements, help map them to embedded software and electrical design specifications, and help translate these into design implementation.
• Develop design requirements, test methodologies, and DOEs to support new product systems.
• Participate in design reviews for multiple subsystems and make technical decisions resulting in a robust, safe, maintainable, serviceable, and cost-effective system.
• Work on updates to parts and testing requirements for units to comply with the latest regulations.
• Interface with Quality to ensure that products are designed for patient safety in terms of FMEA, hazard analysis, and Quality System compliance.
• Provide strong, independent technical support to teams that contribute to the assurance of product quality, reliability, manufacturability, and production efficiency activities or the investigation and corrective action of problems and deficiencies.
• Lead activities related to product verification and device validation. Write formal analysis reports, resulting in clear and accurate messaging about analysis findings to a broad audience.
• Use working knowledge of failure modes of products to work with technicians and other engineers to assess existing and potential failures.
• Work with quality engineers to identify opportunities to improve product quality, reliability, manufacturability, and functionality.
• Develop production test requirements and support the development of manufacturing test applications.
• Understand and operate within the NeoLight Quality System at all times.

What You Will Bring

Required Qualifications

1. Ability to read and interpret engineering specifications, drawings, manufacturing instructions, and technical analyses.
2. Experience evaluating and debugging the electrical design.
3. Critical comprehension of the electrical schematic.
4. Familiarity with PCB design methodologies, including CAD tools and manufacturing processes.
5. Experience applying IEC 60601-1 and related medical device electronics standards.
6. Experience creating detailed design documentation (specifications, design descriptions, verification, and testing plans).
7. Experience using standard electrical debug tools (e.g., scopes, DMM, bench power supply) and other lab equipment to test and debug digital and mixed-signal designs involving multiple PCBs and subassemblies.
8. Experience with circuit simulation tools such as LTSPICE
9. Hands-on experience developing embedded software in C/C++
10. Experience with statistical data analysis (Ex. Minitab, JMP, excel, etc.)

Preferred Qualifications:

1. Experience with a complete life-cycle of an embedded software system.
2. Demonstrated record of developing and commercializing medical devices.
3. Understanding of applicable standards for medical devices: FDA QSR, ISO 13485, ISO 14971, IEC 62304
4. Experience with Electromagnetic Compatibility (EMC), Electrostatic Discharge (ESD), and signal integrity testing to international standards.
5. Knowledge of product development process and design control
6. Experience developing low-level device drivers for hardware peripheral interfaces and devices such as SPI, I2C, USB, LCD, ADC, DAC, RFIC
7. Experience programming PIC32, the SAM4, and the STM32 processors
8. Experience with Integrated Developer Environments
9. Knowledge of optomechanical systems design and basic optic concepts.

Why Join Us?

A career at Neolight means being part of a flat organization where you are empowered to bring your authentic self to work. As a result, you can directly impact and help improve the lives of neonates with preventable medical conditions. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and

committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of Neolight while leaving a legacy at the same time.

What You Will Want to Know:

Working Conditions:

• General Office work. Ability to lift up to 25 lbs.
• Ability to drive to local sites and travel long distances < 10% of the time.

Job Type: Full-time

• Visa Sponsorship: Available for eligible candidate
• Benefits: 401(k), Dental insurance' Flexible schedule, Health insurance, Health savings account, Life insurance, Parental leave, Sick leave, Unlimited Vacation Time, Supplemental pay types: Bonus pay and Stock Options
• Ability to commute/relocate: Scottsdale, AZ 85257. Reliably commute or planning to relocate before starting work (Required)

Application Question(s) – Ask Yourself:

• Do you have experience in the medical product development process and design control?
• Do you have experience with PCB design and embedded system software development?