Director of Research Development

ACE Partners; Ohio; Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

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

Description du poste

I’m partnering with a global contract manufacturer that’s building out its medical device business. The medical device division runs 5 sites and is growing fast, and they need an R&D leader to shape what it builds next.

This is a hands-on leadership role. You’ll own product and process development for customer programmes, from early design through to transfer into production.

What you’ll do

• 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

What you’ll bring

• 10+ years in medical device R&D, with time 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. You understand what customers need and how to deliver it
• Comfortable being based in, or relocating to, Ohio

Why it’s worth a conversation

You get the backing of a multi-billion dollar group, with the pace and visibility of a division that’s still scaling. You’d be shaping the R&D function, not inheriting a fixed one.