- Collaborate with Quality Assurance to define, implement, and maintain manufacturing and
production procedures compliant with FDA, ISO 13485, MDD/MDR, and other applicable
international regulations.
- Ensure manufacturing operations consistently meet quality, regulatory, and documentation
requirements.
- Lead, mentor, and develop manufacturing managers and staff, fostering accountability,
engagement, and a culture of safety, quality, and continuous improvement.
- Establish manufacturing KPIs (e.g., throughput, yield, scrap, on-time delivery, cost) and use
data-driven insights to drive performance improvements.
- Manage multiple manufacturing projects and priorities through clear policies, procedures,
and systems.
- Serve as the primary manufacturing interface with suppliers, contract manufacturers,
auditors, and regulatory agencies, as needed.
REQUIRED SKILLS & EXPERIENCE
8 – 15+ years of progressive manufacturing leadership experience, preferably within the
medical device industry. Final leveling (Senior Director or Vice President) will be
determined based on experience, scope, and organizational needs.
At least 7+ years of progressive responsibility leading manufacturing, production, and
sustaining engineering teams in a regulated environment.
Deep working knowledge of FDA, ISO 13485, MDD/MDR, and international
manufacturing and quality requirements.
Proven experience leading manufacturing scale-up, process validation, and product
commercialization.
Strong background in Lean manufacturing, Six Sigma, and driving measurable
improvements in cost, quality, yield, and delivery.
Demonstrated success in manufacturing transfer from R&D to production and supporting
ongoing sustaining activities.
Experience managing suppliers, component sourcing, and external manufacturing partners.
Ability to work effectively with cross-functional teams, including R&D, Quality,
Regulatory, and Supply Chain, to resolve manufacturing and production challenges.
Excellent verbal, written, and interpersonal communication skills, with the ability to
influence across technical and leadership teams.
Advanced proficiency in Microsoft Word, Excel, and PowerPoint.
