The company is seeking to oversee the full manufacturing lifecycle of a key medical device, ensuring products are manufactured efficiently, meet FDA and ISO standards, and consistently deliver on quality, safety, and reliability.
Requirements
- Strong knowledge of FDA QSR and ISO 13485 requirements.
- Proficiency in Microsoft Office 365; ERP/MRP knowledge is a plus.
- Experience with Lean, Six Sigma, or other process improvement methods preferred.
- Knowledge of medical device manufacturing, product management, or operations within regulated environments.
- Experience with production metrics (yield, throughput, quality, delivery) and driving improvements.
- Familiarity with engineering change orders (ECOs) and production documentation (DMRs, BOMs, work instructions).
- Understanding of continuous improvement initiatives for cost, manufacturability, and quality.
Responsibilities
- Oversee the full production lifecycle for assigned medical device products, aligning production, quality, regulatory, and delivery goals.
- Serve as the primary liaison across project management, manufacturing, quality, regulatory, and engineering teams.
- Ensure compliance with FDA (21 CFR Part 820), ISO 13485, and other applicable regulations.
- Lead production readiness for new product introductions (NPI), including documentation, tooling, training, and process optimization.
- Monitor production metrics (yield, throughput, quality, delivery) and drive improvements.
- Manage engineering change orders (ECOs) and maintain accurate production documentation (DMRs, BOMs, work instructions).
- Drive continuous improvement initiatives for cost, manufacturability, and quality.
Other
- Bachelor’s degree in Engineering, Life Sciences, Operations, or related field (or equivalent experience).
- 3+ years in medical device manufacturing, product management, or operations within regulated environments.
- Supervisory experience in manufacturing.
- Strong analytical, organizational, and problem-solving skills.
- Ability to collaborate with an exceptional cross-functional team.
