US Engineering Director & QMS Leader

Insightsurgery; Houston (TX); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Company Share Options

Retirement plan matching 3%

Healthcare plan

Performance bonus up to 12%

Job summary

Insight Surgery is seeking a Head of US Engineering to join the Senior Management Team, reporting to the Chief Operating Officer. You will lead the US engineering function and coordinate with the UK team to ensure unified design and manufacture of patient-specific devices across regions.

The role includes ownership of US output, team development, regulatory audits (FDA), CAPA closure, and ongoing quality management within ISO 13485 frameworks.

Qualifications

• Engineering degree, bio-medical specialization preferred.
• At least 5 years leading a team of engineers in a commercial environment.
• Sector knowledge of the Orthopedic market and patient-specific devices.
• Minimum 5 years in an ISO 13485 medical device environment.
• Experience with FDA requirements; UK regulations is an advantage.
• Experience fronting external regulatory audits and owning CAPA to closure.
• Knowledge of additive manufacturing is advantageous.

Responsibilities

• Own US engineering output including device design and manufacturing.
• Lead recruitment and define engineering structure in collaboration with UK team.
• Maintain and enforce the QMS across the US region; participate in audits and CAPA.
• Drive continuous improvement in products and services with the COO and sales team.
• Collaborate with UK Engineering to ensure unified design methods and controlled documents.
• Provide hands-on technical leadership in design and manufacturing processes.

Skills

Engineering leadership

ISO 13485

FDA knowledge

Orthopedic devices

Additive manufacturing

Education

Engineering degree, bio-medical specialization preferred

Tools

QMS software

Job description

Insight Surgery is seeking a Head of US Engineering to join the Senior Management Team, reporting to the Chief Operating Officer. You will lead the US engineering function and coordinate with the UK team to ensure unified design and manufacture of patient-specific devices across regions.

The role includes ownership of US output, team development, regulatory audits (FDA), CAPA closure, and ongoing quality management within ISO 13485 frameworks.