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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Konik is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.
Konik has been a leader in the technical staffing industry for more than 50 years, providing the fastest and easiest link between employees and employers. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.