Director of Engineering, Medical Device Manufacturing

Socket.dev; BLOOMINGTON (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

QTS invites a Director of Engineering to guide end-of-line capabilities for medical devices, including assembly, cleaning, packaging, labeling, and sterilization management. You will align business strategy with engineering priorities, develop talent, and drive scalable, compliant processes across programs.

Ideal candidates have extensive leadership experience in regulated manufacturing, a track record of launching complex device programs, and strong customer engagement and strategic planning

Qualifications

• Bachelor’s degree in engineering or related field.
• 10+ years of progressive engineering, manufacturing, or technical operations experience.
• 5+ years of leadership experience with engineering teams and budgets.
• Significant experience in medical device contract manufacturing or regulated manufacturing.
• Experience leading medical device end-of-line capabilities (assembly, cleaning, packaging, labeling, sterilization).
• Proven track record delivering complex medical device programs from feasibility to launch.
• Knowledge of ISO 13485, risk management, validation, and regulatory requirements.
• Strong business and customer-facing technical leadership with measurable results.

Responsibilities

• Lead business development with Sales, Marketing, Operations, Quality, and Finance to qualify and pursue opportunities.
• Translate customer needs into manufacturable, viable solutions.
• Own proposals, feasibility studies, cost models, and launch strategies.
• Build customer confidence and expand key accounts through clear communication of capabilities and risks.
• Develop and execute a scalable, compliant roadmap for end-of-line capabilities.
• Integrate end-of-line requirements in opportunity qualification and NPI.
• Lead commercialization from feasibility to transfer to operations.
• Drive disciplined launch execution and post-launch issue resolution.
• Provide leadership for process validation, packaging validation, cleaning validation, and sterilization validation.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Regulatory knowledge

Quality systems

Problem solving

Communication

Customer engagement

Education

Bachelor's degree in engineering

Advanced degree (MBA/MS)

Tools

ERP

MRP

Product lifecycle management

Job description

QTS invites a Director of Engineering to guide end-of-line capabilities for medical devices, including assembly, cleaning, packaging, labeling, and sterilization management. You will align business strategy with engineering priorities, develop talent, and drive scalable, compliant processes across programs.

Ideal candidates have extensive leadership experience in regulated manufacturing, a track record of launching complex device programs, and strong customer engagement and strategic planning