Lead Systems Designer - Medical Device
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 the qualifications of the position will be contacted. The details of the position are only a summary, other duties 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 to experience 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 date of 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, or veteran status.