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Plexus Corp.
Quality Engineer - Medical Regulatory Compliance
Job Location: Louisville, CO
Are you tired of working on the same exact product or product line, day in and day out? Are you ready to experience the difference? If you answered Yes to these questions, then Plexus may be the right company for you! Plexus Corp. provides comprehensive product development and manufacturing services to Fortune 500 companies in the Wireline/Networking, Wireless Infrastructure, Medical, Industrial/Commercial and Defense/Security/Aerospace industries. At Plexus you will work with knowledgeable employees in a global spirit of cooperative teamwork, integrity and drive. We provide quality services to such customers as GE, Johnson & Johnson, Honeywell, Siemens, and Juniper Networks. Together we will transform our customer's cutting edge ideas into market leading products by employing a wide variety of services including product design, state-of-the-art prototyping, test solutions, board-level manufacturing and higher-level assembly. At Plexus we take pride in our employees and our services. Join our team today and experience the difference that Plexus has to offer.
Job Overview
Plexus Technology Group's Boulder Design Center, a growing electronics product development center of 60 employees located just minutes from the breathtaking Rocky Mountains, is seeking an experienced Medical Regulatory Compliance Engineer. This person will have the overall responsibility for assuring that the product is designed and tested in compliance with all applicable agency requirements, as well as all quality-related aspects of the project. This includes but is not limited to: - participation in the development of product specifications - ensuring project compliance to internal and external standards - coordinating safety agency marking and regulatory compliance - coordinating the risk analysis activities - creating and managing the quality engineering deliverables - generating and coordinating design verification test activities. This person will also serve as the focal point for the project team and the customer regarding items related to safety agency and regulatory compliance as well as Plexus SOP compliance.
Responsibilities
- Identifying the medical device safety standards and regulatory requirements for each unique project.
- Identify and document product specifications related to safety agency and regulatory requirements. Facilitate documentation of functional, electrical, and mechanical specifications.
- Mentor and lead the project team on regulatory and safety agency compliance items.
- Ensure that the planned project activities are compliant with the Plexus' standard operating procedures, the FDA Quality System Regulation (QSR), and ISO 13485 requirements.
- Lead the development of the Product Risk Management Plan and define the required content of the Risk Management File for each unique project
- Lead product Risk Analysis meetings and document the results as specified in ISO 14971. Follow up as required throughout the project to ensure hazard mitigation.
Qualifications
Minimum Qualifications:
- Possess a Bachelors Degree in Engineering
- Possess a minimum of 5 years of medical product development experience.
- Possess a strong working knowledge of IEC/UL 60601-1 & 60601-1-1.
- Possess a good understanding of FDA Quality System Regulations.
- Possess a good understanding of ISO 13485 and the EU Medical Device Directive.
- Experience with the development of System Risk Analysis Reports using processes defined in ISO 14971 & IEC 60601-1-4. **All candidates must have legal authorization to permanently live and work in the United States without visa or employer sponsorship.
At Plexus we realize that our employees are the key to our continued success. That is why we provide a stimulating environment that fosters sharing of ideas, use of the latest technology and teamwork. An environment that supports employees as they take on new challenges and celebrates their successes. In addition to offering a competitive salary and bonus opportunities, Plexus offers an excellent benefits package including a 401(k) plan, tuition reimbursement and medical, dental, and vision insurance.
How to Apply
Experience the difference! To learn more about Plexus and other opportunities visit www.plexus.com today. To apply for this position click here: www.plexus.com
How to Apply:
Plexus Corp.
All offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.
Plexus Corp. is an Equal Opportunity/Affirmative Action Employer.
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