Company:
Konik
Location: Saint Paul
Closing Date: 24/10/2024
Salary: £100 - £125 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description
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
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