Lead Systems Designer - Medical Device

Talascend, LLC; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative global medical technology organization is seeking a Lead System Designer for a fully remote position. This role offers the chance to collaborate with cross-functional teams to drive the development of cutting-edge medical devices. You'll be responsible for overseeing the entire product lifecycle, ensuring compliance with quality standards, and leading design verification activities. If you have a strong background in software development and project leadership, this is an exciting opportunity to contribute to impactful healthcare solutions. Join a forward-thinking team committed to advancing digital health technologies.

Benefits

Health and Disability Insurance

401(k)

Paid Time Off

Company-Paid Holidays

Qualifications

• 8+ years in software/medical product development or program management.
• Experience with NPI regulatory processes and design documentation.

Responsibilities

• Lead full lifecycle development from requirements through commercial release.
• Ensure delivery of design objectives including functionality and compliance.

Skills

Software Development

Project Leadership

Requirements Development

Problem-Solving

Education

Bachelor's in Computer Science or STEM

Master's in Computer Engineering/Computer Science

Job description

A Talascend client is seeking an experienced Lead System Designer (LSD) for a 6-month contract (with the potential for extension). This Fully Remote position requires prior experience in medical device. You’ll have the opportunity to collaborate with cross-functional teams to drive the successful and timely delivery of New Product Introduction (NPI) and Advanced Technology Development (ATD) programs. Benefits offered.

This role supports a global medical technology organization delivering ultrasound consoles, handheld devices, and digital imaging solutions across various market segments. As the demand for digital health solutions grows, the organization is committed to developing a connected ecosystem of devices and software that delivers added value for patients and clinicians.

Responsibilities:

• Serve as a core member of the product development team
• Ensure delivery of design objectives, including functionality, quality, reliability, serviceability, compliance, and cost
• Lead full lifecycle development from requirements through verification, validation, and commercial release
• Oversee system architecture, risk analysis, and design control processes
• Coordinate design verification and validation activities
• Manage integration, manufacturing, and customer support aspects

Quality-Specific Duties:

• Ensure compliance with the company’s Quality Management System
• Complete all required Quality & Compliance training
• Take corrective actions on quality or compliance issues
• Validate and maintain GxP-relevant applications
• Promote a culture focused on quality and compliance

Basic Qualifications:

• Bachelor’s degree in Computer Science or STEM field
• 8+ years of experience in software/medical product development or program management (or Master’s with 6+ years)
• 2–4 years of project leadership in an engineering environment
• Demonstrated success with requirements development, traceability, and lifecycle management

Preferred Qualifications:

• Master’s in Computer Engineering/Computer Science
• Experience with NPI regulatory processes and design documentation
• AI product development experience
• Familiarity with regulatory standards for medical device development
• Strong problem-solving skills in complex technical and business environments
• Ability to manage multiple priorities in a global, matrixed organization

Eligibility Requirements:

• Must be legally authorized to work in the U.S.

#IND

We thank all applicants for their interest. However, only those qualified individuals who closely meet thequalifications of the position will be contacted. The details of the position are only a summary, otherduties may be assigned as necessary.

Background Check and Drug Screen may be required.

Pay range is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited toexperience and geographic location. Talascend also offers a variety of benefits including: health and disability insurance, 401(k),EAP, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on dateof hire, plan requirements, schedule type, and client work site mandates.

Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race,religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, orveteran status.