Manufacturing Engineering Leader — Lean, Automation & Compliance

PRC Medtronic PR Operations Co.; Juncos (PR); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

MIP incentive plan

Job summary

Medtronic is seeking an Engineering Manager, Manufacturing to lead manufacturing engineering functions, drive process robustness, equipment performance, automation projects, and product transfers in a regulated environment. The role requires a bachelor's degree in engineering with 5+ years of relevant experience; an advanced degree with 3+ years is acceptable.

Key expertise includes FDA, GMP, ISO13485, Lean, Six Sigma, and cross‑functional leadership to achieve quality, productivity, and cost

Qualifications

• Requires bachelor’s degree in engineering and 5+ years of relevant experience, or an advanced degree with 3+ years.
• Experience in a regulated manufacturing environment with quality systems.
• Strong knowledge of FDA, GMP and ISO13485 requirements.

Responsibilities

• Plans, directs and implements all aspects of design and development of new medical device products or software systems.
• Oversees quality assurance/control systems, reliability, and technology transfers.
• Guides development of new methodologies, materials, machines, processes or products.
• Directs concept-to-market development and feasibility studies for design.
• Monitors documentation across research and development phases.

Skills

Manufacturing Leadership

Lean Manufacturing

Six Sigma

IQ/OQ/PQ

FDA Regulations

CAPA

Automation Experience

Project Management

Education

Bachelor's degree in engineering

Advanced degree in engineering

Job description

Medtronic is seeking an Engineering Manager, Manufacturing to lead manufacturing engineering functions, drive process robustness, equipment performance, automation projects, and product transfers in a regulated environment. The role requires a bachelor's degree in engineering with 5+ years of relevant experience; an advanced degree with 3+ years is acceptable.

Key expertise includes FDA, GMP, ISO13485, Lean, Six Sigma, and cross‑functional leadership to achieve quality, productivity, and cost