Senior Director Medical Device R&D & New Product

ACE Partners; Ohio; Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

ACE Partners is partnering with a global contract manufacturer to shape its medical device R&D function. We are seeking an hands-on leader to own product and process development from early design through production transfer, across catheter-based and minimally invasive devices for OEM customers.

You will serve as the technical lead in customer discussions and build the team, processes, and capabilities needed to win larger programmes.

Formación

• 10+ years in medical device R&D with experience leading engineering teams.
• Knowledge of design controls, risk management and DV/PV under ISO 13485 and FDA QSR.
• Experience on the CDMO or supplier side is a strong plus.
• Willingness to base in or relocate to Ohio.

Responsabilidades

• Lead the R&D and new product development team across customer programmes.
• Own design and development of catheter-based and minimally invasive devices for OEM customers.
• Act as the technical lead in customer conversations from feasibility through to design freeze.
• Drive design transfer into manufacturing with operations and quality.
• Build the team, processes and capabilities the business needs to win larger programmes.

Conocimientos

R&D leadership

Design controls

Risk management

DV/PV under ISO 13485 and FDA QSR

CDMO/supplier experience

Cross-functional collaboration

Catheter-based device knowledge

Descripción del empleo

ACE Partners is partnering with a global contract manufacturer to shape its medical device R&D function. We are seeking an hands-on leader to own product and process development from early design through production transfer, across catheter-based and minimally invasive devices for OEM customers.

You will serve as the technical lead in customer discussions and build the team, processes, and capabilities needed to win larger programmes.