Project Engineer

Project Engineer - Sustaining
Contract-to-Hire or Direct Hire | Saint Paul, MN | $80k-115k

Konik is partnering with a local manufacturing company that is seeking to add an engineer to their team. This is an opportunity for an experienced engineer with a background in a medical device environment in project, continuation, quality, or research and development engineering. If you are a highly organized engineer with an innate problem-solving and collaborative nature, please keep reading to see if this is the right opportunity for you. In this role, you will be a key contributor with an ability to make a real impact.

What you would be doing:

• Ensure products remain in conformance with regulatory requirements by developing test plans, protocols and reports
• Maintain 1000’s of products to State-of-the-Art
• Act as project lead for FDA, MDR and CE Class I, II and III products
• Provide effective communication of project plans, budgets, resources, and timeline
• Perform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state-of-the-art (Biocompatibility, Packaging, Sterilization, Reprocessing, Human Factors, etc.)
• Oversee production sterilization activities to ensure products may be released to the market.
• Author and maintain test plans, protocols and reports for Verification and Validation activities, applying appropriate statistical methodologies
• Risk Management activities
• Provide support with troubleshooting of manufacturing processes or product issues with manufacturing partners.
• Documentation in compliance with ISO 13485 and FDA 820 quality systems, including design control
• Apply knowledge of ASME Y14.100:2017 Engineering Drawing Practices for creating and maintaining engineering drawings using appropriate tolerances considering design needs and manufacturing process capabilities.

What you have:

• Bachelor's degree in Engineering or related science field
• 5+ years of experience in medical device is required
• Knowledge of product conformance for the FDA, MDR, and CE Marking process
• Technical Writing skills
• AutoCAD and/or SolidWorks – or similar 2D and 3D drafting/modeling software
• Knowledge of ISO 13485 requirements
• Experience with various aspects of medical device development, such as human factors, biocompatibility, sterilization, packaging, etc.
• Strong problem-solving skills with a collaborative nature
• Ability to lead cross-functional teams