November 2024 - Cbee-jobs - Engineering Mailing Lists

Regulatory Affairs Specialist- Medical Devices - Mittal Consulting
by Fleetwood, Josefine 26 Nov '24

26 Nov '24

Regulatory Affairs Specialist- Medical Devices We have a vision of a world where people globally have access to a wide range of safe and effective medical devices which is made possible by accurate and timely regulatory support for our clients. With ever changing guidelines throughout the world, it has become increasingly complicated to get a novel device approved for sale globally. For this to change, our clients need expert and trustable guidance with a quick turnaround. We are a company built on a foundation of challenging the status quo of how both employees and clients work together and grow efficiently by providing the highest level of customer satisfaction and success. Mittal Consulting is seeking a Regulatory Affairs Specialist to help build regulatory process tools and assist with our workload for upcoming projects. We're looking for someone to quickly embed themselves in the industry, showcase entrepreneurial candor and develop a strong regulatory work ethic. **If you are looking for a foot in the door for the Regulatory world- this is your opportunity! ** Responsibilities * Class II and III Medical Device Submissions * Prepare and submit PMA, 180 DS, RTR, 30 DN, 510(k) and De Novo submissions to the FDA * Compilation and submission of tech files/ design dossiers to notified bodies under new EU MDR regulations * Perform quality control (QC) review of regulatory submission documents, i.e., grammatical/spelling, formatting, flow and language and general clarity of text * Verify that documents meet all applicable regulatory submission standards * Maintain product submission planners, submission timelines, and submission logs * Work with clients to determine classification and regulatory pathways for US, EU, and other international markets. * Manage multiple, parallel projects to successful completion. Position Requirements & Experience * A minimum of a bachelor's and or undergraduate degree in biological, biomedical, chemical, engineering or equivalent sciences is required. * Background and work experience in Medical Devices (Not pharma) * Ability to engage with multiple time zones and work with North American and European clients. * Knowledge of FDA medical device regulations is required. Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management is preferred. * Experience with DeNovo or PMAs is preferred. * Client centered focus and problem-solving skills are required. * Strong attention to detail with the ability to multitask and handle multiple responsibilities simultaneously * Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines * Ability to work independently and as part of a team * Minimum 1 year of related regulatory experience, including: * Writing and submitting at least one FDA regulatory submission in the past year. * Writing at least one new product introduction regulatory strategy. * Experience with submitting Pre-Submission meeting requests into the FDA and participating in those meetings. Work Environment and Details * Remote position (Headquarter is in Portland, Oregon) * Flexible Hours * 1099 contract position * Contractor to provide their own office supplies including laptop * Work specific software licenses will be provided (Email, Zoom, Microsoft, CRM etc as required) * Travel will be reimbursed as required https://www.linkedin.com/jobs/view/4082887389/<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linke…> Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Nov 26th Johnson Hall 102 6-7pm Your Resume and It’s Journey hosted by the CBEE Club presented by a Quality Manager at Fujimi Corporation
by Fleetwood, Josefine 25 Nov '24

25 Nov '24

FREE FOOD provided! Your Resume and It’s Journey November 26th in Johnson 102 6=7pm Register in Handshake<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Foregonsta…> There are many resume workshops devoted to how to write a perfect resume. There is also plenty of good advice out there about how to succeed in an interview. This talk is aimed more at the hiring process, your resume’s journey through it, and resume tips at each step. The presenter has a BS in Chemical Engineering from the University of Colorado and MS in Chemical Engineering from Oregon State University. His career experience includes being a Process Engineer/Manager at Dow Chemical Company, Intel Corporation, and ON Semiconductor. He is currently a Quality Manager at Fujimi Corporation. The presenter has experience on both sides of the interviewing processes. He has been on the interviewee side of the table plenty of times with some success. He has also been on the hiring side as a phone screener, interview team member, author of interview questions, and a hiring manager. His goal with this talk is to help students understand the hiring process and the resume advice they receive. Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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EPA is hiring for interns! Apply now!
by Fleetwood, Josefine 22 Nov '24

22 Nov '24

Looking for an internship? We are hiring! Kickstart your career with the EPA! You'll get hands-on experience, work on real projects, and learn about EPA's environmental programs-all while making a difference and building your skills for the future! Learn more and apply today https://spgv.io/6048Brr<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fspgv.io%2…> [An image that states "Now hiring epa.gov/careers".] Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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INTERA Entry Level Environmental Scientist! Apply now!
by Fleetwood, Josefine 22 Nov '24

22 Nov '24

INTERA is seeking a passionate and motivated Entry-Level Environmental Scientist to join our dynamic team in INTERA's Richland, Washington, office. You will play a crucial role in supporting our environmental projects, and work closely with our senior scientists and project managers to analyze environmental data and contribute to impactful environmental studies. Your work will be a valuable asset in driving the innovative solutions needed at the Hanford Site, one of the largest environmental cleanup projects in the world. Apply at <%0dINTERA%20is%20seeking%20a%20passionate%20and%20motivated%20Entry-Level%20Environmental%20Scientist%20to%20join%20our%20dynamic%20team%20in%20INTERA's%20Richland,%20Washington,%20office.%20You%20will%20play%20a%20crucial%20role%20in%20supporting%20our%20environmental%20projects,%20and%20work%20closely%20with%20our%20senior%20scientists%20and%20project%20managers%20to%20analyze%20environmental%20data%20and%20contribute%20to%20impactful%20environmental%20studies.%20Your%20work%20will%20be%20a%20valuable%20asset%20in%20driving%20the%20innovative%20solutions%20needed%20at%20the%20Hanford%20Site,%20one%20of%20the%20largest%20environmental%20cleanup%20projects%20in%20the%20world.%0b%0bApply%20at%20> https://lnkd.in/gNf4DhBd<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Flnkd.in%2…> Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Air Force Research Laboratory's Repperger Research Internship Program - apply now!
by Fleetwood, Josefine 22 Nov '24

22 Nov '24

**NOW POSTED** The Air Force Research Laboratory<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linke…>'s Repperger Research Internship Program is currently accepting applications for Summer 2025. Administered by Experience ORISE<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linke…>, the Repperger program is open to undergraduate and graduate students from a range of STEM disciplines. Apply by January 15! https://lnkd.in/eGpt5uEt<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Flnkd.in%2…> [Image preview] Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Nov 26th Johnson Hall 102 6-7pm Your Resume and It’s Journey hosted by the CBEE Club presented by a Quality Manager at Fujimi Corporation
by Fleetwood, Josefine 21 Nov '24

21 Nov '24

FREE FOOD provided! Your Resume and It’s Journey November 26th in Johnson 102 6=7pm Register in Handshake<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Foregonsta…> There are many resume workshops devoted to how to write a perfect resume. There is also plenty of good advice out there about how to succeed in an interview. This talk is aimed more at the hiring process, your resume’s journey through it, and resume tips at each step. The presenter has a BS in Chemical Engineering from the University of Colorado and MS in Chemical Engineering from Oregon State University. His career experience includes being a Process Engineer/Manager at Dow Chemical Company, Intel Corporation, and ON Semiconductor. He is currently a Quality Manager at Fujimi Corporation. The presenter has experience on both sides of the interviewing processes. He has been on the interviewee side of the table plenty of times with some success. He has also been on the hiring side as a phone screener, interview team member, author of interview questions, and a hiring manager. His goal with this talk is to help students understand the hiring process and the resume advice they receive. Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Oak Ridge Institute for Science and Education (ORISE) Science and Technology Fellowship
by Fleetwood, Josefine 21 Nov '24

21 Nov '24

Are you a solar student, researcher, or professional? Here's your opportunity to work in the solar office at the U.S. Department of Energy advancing solar technologies and deployment! Apply for the Oak Ridge Institute for Science and Education (ORISE) Science and Technology Fellowship by January 15, 2025. Learn more about the program and topics of interest: https://lnkd.in/gB7Yy8rZ<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Flnkd.in%2…> Activate to view larger image, [Image preview] Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Materials Engineering (R&D) – Summer Internship at FormFactor
by Fleetwood, Josefine 21 Nov '24

21 Nov '24

Materials Engineering (R&D) – Summer Internship FormFactor Inc. Livermore, CA In a world driven by the increased demand of technology, semiconductor manufacturers require a trusted partner to pioneer the frontiers of advanced integrated circuits (ICs). FormFactor, Inc (FFI) is the world's leading supplier of semiconductor test and measurement products that power electronic systems used in computing, consumer-technology, automotive, Artificial Intelligence (AI) and other applications. Our cutting-edge solutions are the driving force behind the testing of ICs that power electronic systems across computing, consumer technology, automotive, Artificial Intelligence (AI), and myriad other applications. As a leading player in the semiconductor industry, FormFactor actively seeks out individuals who are not just employees, but passionate contributors eager to thrive in an ever-evolving landscape. At FormFactor, we are not just shaping the future of semiconductors; we are rewriting the narrative of innovation itself. Our commitment extends beyond the technical realm to the very fabric of our culture. Rooted in our core values—Focus on the Customer, Ownership & Accountability, Respectfully & Effectively Communicate, and Motivate & Develop People—we foster an environment where diverse perspectives are not only welcomed but celebrated. Join us in experiencing the exhilaration of collaborating with a dynamic team, pushing the boundaries of what's possible, and contributing to a workplace where your voice is not just heard but valued and empowered. Become an integral part of our journey as we collaboratively Form Our Future Together, setting the stage for a new era in semiconductor excellence. Our Summer Internship Program provides students and recent graduates with hands-on engineering and semiconductor industry experience. We offer incredible learning opportunities by allowing our interns to contribute to meaningful projects. The targeted start date for this internship position is June 23, 2025. This is a full-time, 12-week internship position. https://www.formfactor.com/company/careers/career-opportunities-us-asia/?gn…<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.formf…> Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Clean Water Services Internship apply before 12/2
by Fleetwood, Josefine 20 Nov '24

20 Nov '24

Looking for an opportunity to make an impact in environmental science and engineering? Join our research group as an intern and contribute to groundbreaking projects like: ???? Developing novel methods for measuring greenhouse gas emissions from treatment plants. ???? Continuous water quality sensing in built and natural environments. ???? Forensic investigations to track down 'mystery' gases. What’s in it for you? ✅A mix of hands-on fieldwork and analytical desk work. ✅The chance to lead innovative projects. ✅Build valuable knowledge, skills, and connections. ✅A paid internship with Clean Water Services on your resume! We’re excited to support your career in environmental engineering or science. Closing date is 12/2/2024 5:00 PM Pacific. Know someone who’d thrive in this role? Share this post with them! ???? https://lnkd.in/gcHDbJdd<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Flnkd.in%2…> Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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Lazarus 3D Info Session Nov 20th in Johnson 102 5-6pm - Meet CBEE Alum! Free food!
by Fleetwood, Josefine 20 Nov '24

20 Nov '24

Biomedical Engineering Society hosts Lazarus 3D Info Session Nov. 20th Johnson 102 5-6pm Register in Handshake<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Foregonsta…> All majors are welcome - free food provided Overview of Lazarus 3D: Surgeon skill and experience are the biggest determinants of patient outcomes. Unfortunately, surgeons learn hands-on skills by operating on patients and sometimes they make costly mistakes. Lazarus 3D's Pre-Sure platform allows surgeons to rehearse every surgery ahead of time on a replica of their patient created in hyper realistic materials. This technology has the potential to transform patient safety and outcomes. Lazarus 3D's Skill-Sure platform delivers world class surgical training solutions to healthcare professionals, reducing the learning curve, aiding development of innovative solutions, and is used by medical device companies for training, demonstration and marketing. Pre-Sure and Skill-Sure models mimic the soft, realistic textures of real organs and provide a unique hands-on operative experience. Our mission is to help doctors Operate with Confidence: Lazarus 3D is driven by a singular mission: to eliminate surgical errors. Our technology helps doctors Operate with Confidence. Join us at Lazarus 3D as we define a new era of surgical precision and personalized care. People Presenting: Nancy Lime, COO Michael Tylinski, Research Associate Scientist Maggie Tinsley, Production Technician (BS Bioengineering, June 2024) Josh Heisler, Design Engineer 1 (BSME, September 2024) Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood(a)oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>

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