Principal Software Engineer – Medical Instrumentation

HiArc; Merrimack (NH); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

9/80 Schedule

401(k) Program

Medical Insurance

Dental Insurance

Vision Insurance

Disability Coverage

Wellness Discounts

Basic Life Insurance

Additional Life & AD&D Insurance

Flexible Vacation & PTO

Paid Parental Leave

Employee Referral Program

Long Term Care Insurance

Legal Insurance

Identity Theft Insurance

Pet Insurance

Tricare Supplement

Job summary

HiArc is seeking a senior software architect to lead architecture, design, and development of regulated embedded and desktop software for complex electromechanical medical instruments. You will provide technical leadership and mentorship while ensuring compliance with medical device safety and quality standards.

You will oversee development lifecycles in line with IEC 62304 and ISO 13485, and collaborate across disciplines to deliver robust, safe medical software solutions.

Qualifications

• Bachelor's degree in Computer Science or related field.
• 10+ years of hardware-integrated software development experience.
• Proven expertise in C#, C++, and regulated medical software lifecycles including IEC 62304 and ISO 13485.

Skills

C#

.NET 8+

C++

Object-Oriented Design

Embedded Software

IEC 62304

ISO 13485

FDA 21 CFR Part 820

Motion Control

Fluidics

Azure DevOps

Git

CI/CD

Agile

Software Architecture

Risk Management

Education

Bachelor's degree in Computer Science or related field

Tools

Azure DevOps

Git

CI/CD

Job description

Lead the architecture, design, and development of regulated embedded and desktop software for complex electromechanical medical instruments. Provide technical leadership and mentorship while ensuring compliance with medical device safety and quality standards.

Requirements:

Requires a Bachelor's degree in Computer Science or a related field and over 10 years of experience in hardware-integrated software development. Must have proven expertise in C#, C++, and regulated medical software lifecycles including IEC 62304 and ISO 13485.

Key Skills:

• C#
• .NET 8+
• C++
• Object-Oriented Design
• Embedded Software
• IEC 62304
• ISO 13485
• FDA 21 CFR Part 820
• Motion Control
• Fluidics
• Azure DevOps
• Git
• CI/CD
• Agile
• Software Architecture
• Risk Management

Benefits:

• 9/80 Schedule
• 401(k) Program
• Medical Insurance
• Dental Insurance
• Vision Insurance
• Disability Coverage
• Wellness Discounts
• Basic Life Insurance
• Additional Life & AD&D Insurance
• Flexible Vacation & PTO
• Paid Parental Leave
• Employee Referral Program
• Long Term Care Insurance
• Legal Insurance
• Identity Theft Insurance
• Pet Insurance
• Tricare Supplement