R&D and Design Assurance Director

CONFIDENTIAL RETAINED SEARCH | MEXICO LIFE SCIENCES

Search Reference: TNF-MX-RD-2026 | Product Development Leadership Mandate, Mexico Life Sciences

ABOUT THIS SEARCH

Top Notch Finders has been retained on an exclusive and strictly confidential basis to identify a R&D and Design Assurance Director for a client in Mexico’s medical device, biotech, pharmaceutical, and techbio sector. To protect the interests of our client and of every candidate who engages with us, the identity of the company is disclosed only to qualified candidates under a confidentiality agreement. All inquiries and applications are received and managed solely by Top Notch Finders.

POSITION SNAPSHOT

• Company profile: Medical device or combination-product developer connected to U.S. medical technology corridors.
• Reports to: VP of Operations / Chief Technology Officer.
• Location: Mexico medtech corridor with close U.S. connectivity (Baja California or Jalisco); specifics disclosed to qualified candidates.

THE OPPORTUNITY

The R&D and Design Assurance Director leads product development and design-control processes for medical device and combination-product portfolios, requiring hybrid biotech/medtech leadership capable of operating with startup agility while navigating Mexico’s regulatory density.

KEY RESPONSIBILITIES

• Lead product development programs from concept through design transfer to manufacturing.
• Own design control processes and design history file (DHF) documentation supporting regulatory submissions.
• Ensure design assurance practices align with both U.S. FDA and Mexican COFEPRIS submission pathways.
• Partner with Quality and Regulatory Affairs on risk management and design verification and validation.
• Build and lead cross-functional engineering and design assurance teams.
• Manage relationships with U.S.-based corporate R&D functions and cross-border design transfer projects.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Bachelor’s or advanced degree in biomedical, mechanical, or electrical engineering, or a related life sciences field.
• 8+ years of R&D or design assurance leadership in medical device or combination-product development.
• Hands-on experience managing design history files and design control documentation.
• Dual fluency in FDA and COFEPRIS submission requirements.
• Experience operating in hybrid startup/regulated-industry environments; ISO 14971 risk management fluency.

CONFIDENTIALITY AND HOW TO APPLY

This is a discreet, retained engagement. Your candidacy will never be presented to any organization without your explicit prior authorization, and no application will be visible to the hiring company at this stage. Accomplished R&D and design assurance leaders are invited to submit a resume in confidence, in English or Spanish, through the Top Notch Finders website. Please reference search code TNF-MX-RD-2026 in your submission. Do not include patient-identifiable, trial-blinded, or other confidential clinical or proprietary information of any kind in your application materials. Only candidates whose backgrounds align closely with the mandate will be contacted.