Title : Design Assurance Engineer, Contractor

Duration: Contract Role

Location : Hybrid; Minnetonka, MN

Pay Rate: $48/hr on W2

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Drives mechanical product design quality, reliability, and compliance with standards and regulations
• Leads and supports on-time completion of design control deliverables
• Critically evaluates mechanical product designs, identifies potential design quality issues, and drives issue resolution
• Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization
• Develops release testing plans for new products
• Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
• Supports and ensures on-time execution of Quality Plans for OEM manufacturing for development projects and design changes
• Supports manufacturing process development & qualification for new product commercialization and product changes

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

3+ years relevant experience within the medical device industry or related function

Other skills and abilities:

Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred

Preferred/Beneficial:

Design for Six Sigma and Critical to Quality training and experience

Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs

Experience of participation in audits

ASQ certification