Medical Device Program Manager (ISO 13485)

Balda-C-Brewer; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Balda-C-Brewer in Ontario, CA is seeking a Full Time Professional to lead engineering and program management for new product introductions from concept to manufacturing within a contract manufacturing setting.

The role requires collaboration with cross-functional teams, review of drawings, estimating time and costs, and ensuring compliance with medical manufacturing standards. Travel up to 10% may be required, and PMP is preferred.

Qualifications

• BS Engineering or equivalent combination of education and experience.
• Minimum 5 years of injection molding experience.
• Experience in ISO 9001 environment and knowledge of ISO 13485, and FDA CFR 21 820 is a plus.
• PMP certification is preferred.

Responsibilities

• Lead project launches and integration of new programs.
• Coordinate cross-functional teams to meet goals and deliverables.
• Build face-to-face engineering relationships with customers for on-time delivery.
• Review drawings and identify manufacturing requirements and constraints.
• Prepare quotes and final proposals, including BOMs and cost estimates.
• Procure materials and assets for projects.
• Ensure adherence to quality planning and validation protocols (IQ/OQ/PQ) for medical products.
• Utilize MS PowerPoint to generate client and internal proposals.
• Provide leadership to defend processes and profitability.

Skills

Project management

Cross-functional collaboration

Analytical thinking

MS Office suite

Minitab

Education

BS Engineering

Tools

MS Word

MS Excel

MS Outlook

MS PowerPoint

MS Projects

Minitab

Job description

Balda-C-Brewer in Ontario, CA is seeking a Full Time Professional to lead engineering and program management for new product introductions from concept to manufacturing within a contract manufacturing setting.

The role requires collaboration with cross-functional teams, review of drawings, estimating time and costs, and ensuring compliance with medical manufacturing standards. Travel up to 10% may be required, and PMP is preferred.