Manufacturing Director (Biotechnology Sector)

Manufacturing Director (Biotechnology Sector)

Reporting to the Chief Operations Officer, the Manufacturing Director is responsible for leading and managing the end-to-end manufacturing operations of our specific product lines. This role ensures that manufacturing processes meet strict quality, regulatory, cost, and delivery standards in compliance with ISO 13485, FDA, and other applicable medical device regulations. The ideal candidate will bring strong leadership, operational excellence, and experience in scaling up production of high-precision diagnostic equipment.

KEY ACCOUNTABILITIES

1. Leads daily manufacturing operations to ensure safety, quality, delivery, and cost targets are met.
2. Oversees the implementation of lean manufacturing and continuous improvement strategies.
3. Drives capacity planning, resource allocation, and production scaling to meet business demand.
4. Ensures strict compliance with regulatory and quality system requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
5. Collaborates with R&D, Quality, Supply Chain, and Technical Support teams to support new product introductions (NPI).
6. Monitors and improves key manufacturing KPIs: OEE, yield, scrap rates, downtime, and lead times.
7. Develops and manages manufacturing budgets, staffing plans, and capital expenditures.
8. Builds, mentors, and leads a high-performing team of manufacturing managers, engineers, and technicians.
9. Fosters a culture of safety, accountability, and operational excellence.
10. Participates in audits (internal and external) and leads the resolution of any identified gaps.

KNOWLEDGE AND EXPERIENCE

1. Minimum of 10 years of experience in manufacturing, with at least 5 in a leadership role.
2. Desirable experience in the production of diagnostic, medical, or laboratory equipment.
3. Strong understanding of quality systems and regulatory compliance for medical devices.
4. Excellent knowledge of lean manufacturing, Six Sigma, and continuous improvement methodologies.
5. Demonstrated ability to scale manufacturing operations in a regulated environment.
6. Exceptional leadership, communication, and organizational skills.
7. Experience with automation, robotics, or high-precision assembly processes.
8. Familiarity with ERP/MES systems (preferably Microsoft Business Central).
9. Certification in Six Sigma or Lean (e.g., Green/Black Belt).

SKILLS

• Strong analytical skills
• An agile, collaborative, and consultative working style
• Level-headed and diligent approach to problem-solving
• Negotiation skills in English

Seniority level

Director

Employment type

Full-time

Job function

Manufacturing

Industries

Medical Equipment Manufacturing

This job is active and accepting applications.