Global Medical Device Program Manager – Manufacturing

Cretex Medical; Elk River, Northern (MN, KY); Hybrid; USD 124,000 - 155,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Cretex University training

Discretionary holiday bonus

Wellness program

Job summary

Cretex is seeking a Program Manager to lead high-complexity programs across the enterprise, including cross-company and international transfer efforts. This role drives on-time, on-budget delivery with strong collaboration across engineering, quality, planning and customer teams.

The successful candidate will have extensive medical device lifecycle experience, certifications in project management, and a proven ability to optimize margins while guiding program transitions into production.

Qualifications

• Associate degree or commensurate experience in a related field.
• 10 years of experience in Program/Project Management.
• 4+ years 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).
• 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 customer and manufacturing programs, including cross-company and international transfer programs.
• Cultivate partnerships with internal teams and external customers to meet program objectives.
• Ensure programs meet scope, schedule, budget, and quality expectations.
• Oversee transition of projects into manufacturing and monitor production to target cost savings.
• Promote teamwork across stakeholders to drive seamless project execution.
• Champion customer needs and maintain progress on programs across the organization.
• Leverage manufacturing capabilities knowledge to support cost-effective solutions.

Skills

Program management

Cross-functional leadership

Microsoft Project

Excel

Visio

Regulatory knowledge (ISO 13485/FDA)

Communication

Attention to detail

Fast-paced manufacturing

Education

Associate degree

Bachelor's degree in engineering or related field

Tools

Excel

Microsoft Project

Visio

Job description

Cretex is seeking a Program Manager to lead high-complexity programs across the enterprise, including cross-company and international transfer efforts. This role drives on-time, on-budget delivery with strong collaboration across engineering, quality, planning and customer teams.

The successful candidate will have extensive medical device lifecycle experience, certifications in project management, and a proven ability to optimize margins while guiding program transitions into production.