Senior Systems Engineer – Medical Device (Arden Hills, MN) Contract – Senior-level (On-site) - Pharmavise Corporation
Saint Paul, MN 55112
About the Job
Job Role: Senior Systems Engineer – Medical Device (Arden Hills, MN) Contract – Senior-level (On-site)
Overview:
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn:
Our Fortune 500 client has an exciting opportunity for a Senior Systems Engineer.
Job Summary:
We are seeking a highly skilled and experienced Senior Systems Engineer with expertise in Bluetooth Low Energy (BLE), Radio Frequency (RF) technologies, and medical device development. The ideal candidate will work collaboratively with cross-functional teams, in leading the design, development, and integration of advanced wireless communication systems for medical devices, ensuring high performance, reliability, and compliance with medical standards.
Responsibilities and Job Requirements:
• System Design and Development: Lead the design and development of BLE and RF systems for medical devices, including hardware and software components, ensuring compliance with industry standards, regulations, and best practices.
• Integration and Testing: Oversee the integration of BLE and RF subsystems into medical devices, ensuring seamless functionality and performance including conducting system-level characterization and testing.
• Technical Leadership: Provide technical guidance and mentorship to junior engineers, fostering a collaborative and innovative work environment.
• Project Leadership: Manage project timelines, resources, and deliverables, ensuring projects are completed on time and within budget.
• Performance Optimization: Analyze and optimize system performance, addressing any issues related to RF interference, signal integrity, and power consumption.
• Documentation: Prepare detailed system architecture and design documentation, including block diagrams, flowcharts, and design/interface specifications.
• Compliance and Standards: Ensure all designs comply with relevant industry standards and medical regulations, including FDA (Food and Drug Administration) and ISO standards. Assist in the preparation and submission of regulatory documentation related to the BLE telemetry system design.
Qualifications:
• Education: Bachelor's or master's degree in electrical engineering, Computer Engineering, Biomedical Engineering, or a related field.
• Experience: Minimum of 5 years of experience in systems engineering, with at least 3 years of experience with BLE / RF technologies.
• Technical Skills: Proficiency in RF design, BLE protocols, signal processing, and medical device development.
• Tools and Software: Experience with RF simulation tools, embedded programming languages, and medical device development tools.
• Soft Skills: Strong problem-solving abilities, excellent communication skills, and the ability to work effectively in a team environment.
Preferred Qualifications:
• Experience with IoT devices and applications.
• Knowledge of other wireless communication protocols (e.g., Wi-Fi, Zigbee).
• Familiarity with regulatory requirements for wireless medical devices such as IEEE 11073, ISO 13485, and FDA guidelines.
Other Details:
Full-time (8 hours)
12 Months Contract (Contract to Hire)
On-site at Arden Hills, MN facility
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact .
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
E-Verify Participation:
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.
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