Global Medical Device Program Manager

Socket.dev; Elk River (MN); On-site; USD 124,000 - 155,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus program

Cretex University

Employee assistance program

Wellness program

Life insurance

Paid time off

Job summary

Cretex seeks a Program Manager to oversee high-complexity programs with a focus on cross-company and international transfer initiatives. You will ensure projects meet schedule, budget, and quality targets while coordinating with internal teams and external customers.

With extensive experience in medical device lifecycles, you will guide proposals, contract reviews, and process improvements, driving gross margin targets and cost-effective solutions across engineering, quality and manufacturing

Qualifications

• Associate degree or commensurate experience in a related field.
• 10 years of experience in Program/Project Management.
• 4+ years of experience in a business leadership role
• Extensive experience in medical product lifecycle management
• Proficiency with project management software (e.g., Excel, Microsoft Project, Visio or equivalent) for managing multiple projects simultaneously and effectively communicating status.
• Knowledge of ISO 13485 and FDA regulations.
• Proven track record in root cause analysis, corrective actions, and preventative measures.
• Exceptional verbal and written communication abilities.
• Strong attention to detail with excellent organizational capabilities.
• Ability to thrive in a fast-paced, team-oriented manufacturing environment.

Responsibilities

• Oversee higher complexity programs through PM system; focus on cross-company and international transfer programs.
• Cultivate partnerships with internal teams and external customers to meet program objectives.
• Ensure requirements, scope, schedule, budget, and quality expectations are met.
• Transition projects to manufacturing and monitor production against cost targets.
• Promote teamwork across stakeholders for seamless execution.
• Champion customer needs across the organization with timely progress.
• Understand manufacturing capabilities and processes for the medical device industry.
• Provide input on proposals, contracts, and system enhancements.
• Collaborate with engineering, quality, and operations to uphold margins.
• Oversee successful project transitions into production.

Skills

Program/Project management

Verbal and written communication

Cross-functional collaboration

Regulatory knowledge

Process improvement

Education

Associate degree or commensurate experience

Bachelor’s degree in engineering or related field

Tools

Excel

Microsoft Project

Visio

Job description

Cretex seeks a Program Manager to oversee high-complexity programs with a focus on cross-company and international transfer initiatives. You will ensure projects meet schedule, budget, and quality targets while coordinating with internal teams and external customers.

With extensive experience in medical device lifecycles, you will guide proposals, contract reviews, and process improvements, driving gross margin targets and cost-effective solutions across engineering, quality and manufacturing