Director of Medical Device Systems Engineering

Werfen; Norcross (GA); On-site; USD 180,000 - 240,000; Full time

Job summary

Werfen seeks a Director of Systems Engineering to provide strategic and technical leadership for the Systems Engineering function. This role drives development of on-market and new product medical device systems from concept through commercialization, translating requirements into innovative, compliant products.

You will lead a multidisciplinary team, establish governance, and champion data-driven decision making while collaborating with external partners and internal stakeholders to deliver

Qualifications

• Bachelor's degree in engineering required; advanced degree preferred.
• Extensive experience in medical device systems and product development.
• Experience communicating with executive leadership and external partners.

Responsibilities

• Provide strategic leadership for a multidisciplinary systems engineering team.
• Govern design controls, risk management, and regulatory compliance.
• Guide system architecture across hardware, software, and electronics.
• Lead portfolio planning, roadmaps, and development programs.
• Oversee verification, validation, and testing infrastructure.
• Manage external partners and vendor relationships.

Skills

Regulatory knowledge

IVD automated testing

Design controls

Risk management

Leadership

Education

Bachelor's degree in engineering

MS/PhD in Engineering/Systems/Biomedical

Job description

Werfen seeks a Director of Systems Engineering to provide strategic and technical leadership for the Systems Engineering function. This role drives development of on-market and new product medical device systems from concept through commercialization, translating requirements into innovative, compliant products.

You will lead a multidisciplinary team, establish governance, and champion data-driven decision making while collaborating with external partners and internal stakeholders to deliver