CMTI Alumni

Manufacturing Engineer I at Welch Allyn

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• Location: Syracuse, NY

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PhD Graduate Student

Margaret is interested in the pediatric cardiovascular space and is at the University of Colorado Denver in the Jacot Lab for Pediatric Regenerative Medicine within the Bioengineering Department.   She will be working with two pediatric cardiologists on a tissue engineered vascular graft for congenital heart defect repair.

Resume

• Location: University of Colorado

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Continuous Improvement / Quality Assurance Engineer

Resume

• Location: CooperVision

Resume

Validation Engineer

• Worked on full lifecycle validation for computerized systems, lab and manufacturing equipment
• Prepared validation documents (VP, URS, FS, IQ/OQ/PQ, TM & VSR)
• Performed the execution of written protocols
• Investigate root cause problems from data trend and generate progress reports with corrective actions 
• Review and approve protocols/reports before approval
• Ensure validation deliverables follow SOP guidelines and Change Controls
• Coordinate validation activities with the project manager and the client to complete tasks on time.

• Location: PSC BioTech
• Website: Link

Associate Clinical Account Specialist

Scott is completing a six month training position as an Associate Clinical Account Specialist.  Biosense Webster trains employees to become a full Clinical Account Specialist (CAS) within the company.   Once he has completed the training, he will move into a CAS position where he will be responsible for providing clinical product knowledge as well as technical assistance to the EP physician during ablation procedures.  Physician and staff education is also a key responsibility of this role.  A CAS is also responsible for business growth and product sales in their assigned region.

• Location: Biosense Webster
• Website: Link

Validation Engineer

• Location: Albany Molecular Research Inc.
• Website: Link

Associate Neurophysiologist

Associate Neurophysiologist with Nuvasive Clinical Services providing intra-operative monitoring during various surgeries.

• Monitor patients’ nervous system in various surgeries using a wide range of neurophysiological techniques across many testing modalities including SSEP, S-EMG, T-EMG, TceMEP and TOF
• Interact with surgeons and surgical team to provide interpretive data, including any findings and significant changes
• Consult with surgeon regarding structures at risk and modalities to be monitored.
• Consult with anesthesia regarding regimens acceptable for testing
• Interact with patient, when applicable, to obtain a detailed history and clearly explain the neurophysiological tests to be performed.
• Accurate placement of stimulating and recording electrodes using the 10-20 system of electrode placement.
• Display and label waveforms for marking, measuring and calculating information such as latencies, amplitudes and conduction times following established guidelines and protocols

• Location: NuVasive Inc.
• Website: Link

Associate Verification and Validation Engineer

• Plans, realizes, and delivers in Systems & Component (HW & SW) level Verification implementation, analysis and reporting.
• Contributes to documentation generation for Design Verification and Validation (V&V) processes and tools.
• Supports environmental testing, Standards testing and usability testing.
• Performs and documents test cases to exercise the product to verify requirements and reveal potential defects.
• Maintains real time log of executed tests, results and environment, reviews and reports results.
• Designs, Develops, Debugs Verification Test Protocols and Test Cases.

• Location: Medtronic (formerly Heartware)
• Website: Link

Development Engineer

Contract Development Engineer with Adecco at Zimmer Biomet. Responsibiliries include reviewing documentation in Trauma Orthopaedic design controls, performing engineering analysis to determine products failure modes and verify the product withstand those failure mode, and update documentation for verification in existing design history files.

• Location: Zimmer Biomet
• Website: Link

Systems Engineer

As part of the Mechanical Circulatory Support group at Medtronic I work with system, subsystem, and lower-level requirement documents in order to drive designs of future devices as well as driving design changes to existing products already on the market. Also, involved with risk analysis and assessment in order to make sure that our requirements cover the full scope of the scenarios that our devices will be used in.

• Location: Medtronic (formerly Heartware)
• Website: Link

Associate Product Manager I

https://www.linkedin.com/feed/update/urn:li:activity:6246217730970652672/

• Location: K2M
• Website: Link

System Engineer

Lisa is currently within the R&D Functional Performance group at Ortho Clinical Diagnostics in Rochester.

Lisa Benison was the first the recipient of the Medtech Association’s first Engineering World Health (EWH) Summer Institute scholarship.  EWH is a non-profit organization, founded in 2001, that collaborates with students to improve healthcare in developing countries. EWH works to harness the resources of collegiate engineering programs through a network of university-based chapters nationally and throughout New York State. Benison and other EWH students are now in Tanzania to use or repair medical products in the field, at a hospital or at a clinic. The scholarship is a matching grant of ,750 from MedTech members, which helped to cover the cost of travel and lodging.

• Location: Ortho Clinical Diagnostics
• Website: Link

Research Engineer II

Jayne works as part of the research department within the Advanced Surgical Devices unit of Smith & Nephew.  Our focus is on FEA and mechanical testing of hip, knee, and trauma devices and instruments. As a research engineer it is her role is to be the biomechanical testing expert within a project team. The biomechanical studies performed support early product development, safety and efficacy questions, regulatory submission requirements (FDA & international) and marketing. 

• Location: Smith & Nephew
• Website: Link

Associate R&D Engineer

Qinglong completed his M.S. in Materials Science at University of Rochester.  He participated on projects related to Orthopaedics within the CMTI.  His main responsibility is as a design engineer for arthroscopic surgeries of the shoulder and knee.  

• Location: DePuy Synthes Mitek Sports Medicine, Suzhou City, Jiangsu, China

Ortho Clinical Engineer

Courtney works with surgeons to help them plan their surgical cases using 3D modeling software. For each case, she creates a patient-specific model of the anatomy and then sit with the surgeon over a webmeeting to discuss the surgical approach. She then designs the surgical guides that they use during the surgery to cut the bone and have them 3-D printed in time for the case. Her work focuses on Orthopedic cases but the company also works in the Craniomaxillofacial area as well.  The job includes travel to conferences and she is on call for the surgeons or right in the OR with them while they use the technology.

• Location: Materialise USA, Plymouth, MI
• Website: Link

Product Development Engineer II

Chad works as a Product Development Engineer II at Smith & Nephew Advanced Surgical Devices (ASD) in Andover, MA.   In his role, he helps to sustain their products in the field.   His position also involves: 1) Designing and re-engineering products based on customer feedback, quality matters and supply chain enhancements, 2)Working closely with internal and external partners to develop and control prototypes accomplishing laboratory testing, design refinement, design verification/validation and documentation, 3)  Conducting necessary engineering analysis at a system and component level, and 4) Maintaining and updating documentation per procedures and guidelines.

• Location: Smith & Nephew

Process Engineer

Laura supports contact lens design and development through data analysis, coordinating product testing, technical report writing, and general project team support at Bausch & Lomb in Rochester, NY.

• Location: Bausch & Lomb in Rochester, NY
• Website: Link

Associate Biomedical Engineer

Ben currently works as an Associate Biomedical Engineer at Ximedica in Providence, RI.  In his role, he supports a product development team that is working on a next generation surgical robotics system. His time is split between their EE and software group, and he provides support with prototyping, fesability testing, and electrical board design.

• Location: Ximedica in Providence, RI
• Website: Link

Associate CMC Regulatory Sciences Specialist

Assists the Commercial Products team with maintaining regulatory filings in US and ex-US countries. Assists with completing regulatory filings for approval in ex-US countries. Assists with the completion of amendments to commercially approved regulatory filings.

• Location: Regeneron Pharmaceuticals, Inc.
• Website: Link

Product Development Engineer

As a project engineer, Nathan is responsible for leading contract product development services at FTT. As a member of the FTT Medical division, there is a strong emphasis on medical device development and design for manufacturing, where applicable projects range in development stage from infancy to post-market release optimization. Because FTT provides services to a variety of medical and industrial customers, their work is not limited to a single field or discipline. This allows for significant exposure to the industry as a whole and forces FTT to not only be highly regulated by several industries (i.e. medical, aerospace etc.), but be knowledgeable regarding a vast amount of new technologies, designs, and processes. Outside of product development, Nathan provides engineering support via 3D solid modeling, rapid prototyping, fixture design, process development, and quality control. Additionally he functions as an account manager within the medical division where he assists with quoting new projects and overseeing the resultant product manufacturing for a few medical device customers.

• Location: Rochester NY
• Website: Link

Associate Product Development Engineer

As an Associate R&D Product Development Engineer, Trauma, Megan assists with the design and development of improvements and modifications to current products. She works with product managers, design engineers, surgeons, manufacturing, regulatory affairs, and other team members to develop product requirements and concepts on existing products. She completes necessary documentation to support design/development changes. She assists with clinician-interactions for purpose of design development, finalization, and clinical evaluation of improvements and modifications. She assists the manufacturing engineers in the development of final design, manufacturing processes, and inspection processes.

• Location: DePuy Synthes, a member of Johnson & Johnson
• Website: Link

Neurosurgery Resident

Jonathan Stone is a resident in neurosurgery at the University of Rochester and is a graduate of the CMTI MS program. He attended medical school at the University at Buffalo School of Medicine and graduated with AOA in 2010. He performed his undergraduate studies at Drew University where he graduated Summa Cum Laude in 2006 after completing a honors thesis in neuroscience. He plans on pursuing general neurosurgery but has an interest in pediatrics. His current research projects include a retrospective shunt database, quality analysis of carotid artery ultrasound for predicting stenosis and techniques for percutaneous trigeminal rhizotomy. His hometown is Rockland County, New York and he currently lives in Cornhill, Rochester. He enjoys anything outdoors including snowboarding/skiing at Bristol, hiking/camping at Letchworth and Allegany State Parks, and bike riding on the canal trails in Rochester.

• Location: University of Rochester
• Website: Link

Product Applications Development Engineer

As Product Applications Development Engineer, she interfaces between R&D and early adopters of the technology to develop and champion new standards of diagnosis and care. She support these clinicians in the ICU, OR, and Catherization Lab with technical, educational, and training support.

• Location: Transonic Systems
• Website: Link

Product Development Engineer

Formerly a Research Sr Engineer I at Zimmer Biomet

• Location: DePuy Synthes
• Website: Link

Development Engineer

Mohammad is working at Bausch & Lomb as a Development Engineer in the lens design group. The lens design group is involved in all aspects of product life cycle of the medical device, from designing and developing the contact lenses to communicating with clinicians to gain feedback about the lenses. 

• Location: Bausch + Lomb
• Website: Link

Field Clinical Studies Engineer

As a Field Clinical Studies Engineer with Biotronik, I work with our study sites in the greater New York area. These include pre-market and post-approval as well as after-market studies. During the start-up process I will screen potential sites for participation and train research personnel on the protocol. Once the site is open, I work with them to promote enrollment and increase compliance throughout the duration of the trial. I interact with physicians, research coordinators, and Biotronik representatives and occasionally will sit in on a case.

• Location: BIOTRONIK
• Website: Link

Biomedical Engineer and Scientific Reviewer

Lead Reviewer for the Neurostimulaton Devices Branch of the Division of Neurological and Physical Medicine Devices within the Office of Device Evaluation. Review pre-marketing submissions for a variety of device specialities and clinical presentations related to neurology. Assemble teams of expert consultants across the agency to assist in reviews as necessary. Provide guidance to and promote interaction with industry, academic, and government sponsors. 

Division Representative for the Early Feasibility Study program. The EFS program is a strategic priority for the Center of Devices and Radiological Health. These studies are focused on promoting innovation of novel medical device technology in the United States and thereby enabling US patients to access these technologies first in the world. As a representative for DNPMD, I interact with sponsors submitting within all three branches of the division from very early stage through to IDE decision. I also provide guidance and training to the other reviewers in my division, and act as a liaison between my division and the EFS program leads.

• Location: FDA

Applications Engineer, Medical Optics

As an Applications Engineer, Spencer is a customer-facing engineer and the initial technical point of contact for new and existing customers in the medical device market.  He works with customers to understand their underlying needs and wants, develop products, develop product specifications, and determine initial feasibility for new products.  Internally, Spencer acts as the voice of the customer; working with the research and development, regulatory, quality, and manufacturing teams he is responsible for making sure that the customer’s needs are met.  Also in this role, Spencer helps to develop and execute our Medical Optics strategy, conducts new business development, and has some product management responsibilities.

• Location: Corning Incorporated
• Website: Link

Quality Engineering

Martech specializes primarily in manufacturing extruded tubing and injection-molded components for final assembly catheters used for hemodialysis applications.  The Quality Engineering group deals with solving quality issues in the company’s product line resulting from customer complaints and during new product development.  Martech is run by the same management and therefore works very closely with Medical Components Inc. (Medcomp), which is the company that initiates the development of most new products and eventually sells the catheters directly to hospitals.  Martech also supplies tubing and molded parts to many other customers, including B Braun, Medtronic, and Angiodynamics to name a few.  Martech is also associated with Point Medical Corp. in Indiana, which manufactures silicone-based catheters and medical products. 

“The CMTI program did a great job of familiarizing students with the entire scope of medical device development from the idea and concept stage through prototype development.  The clinical exposure during the summer provides an opportunity to better understand what physicians look for in a medical device and how to communicate design concepts to health care professionals. The design aspect of the program introduces students to the terminology and design processes used in the industry, which makes transitioning into industry easier because you’ve already learned the basics and only have to adjust to the specific details of your company’s procedures and product line once you are hired.”

• Location: Martech Medical Products
• Website: Link

Assistant Director for Undergraduate Programs

As Assistant Director for Undergraduate Programs, Alvin will collect and analyze data for the purpose of identifying process efficiencies and implementing process improvement plans. He will also develop “best practice” processes and procedures for  monitoring and measuring the status, performance and outcomes of Hajim undergraduate degree programs.

Prior to working in the Dean's Office, he worked in Wilson Commons Student Activities, where he served for two years as staff adviser and program manager, and was in charge of planning large scale, community-building events for undergraduates and the College community, as well as standardizing workflows for student group event registration and approval.

• Location: Hajim School of Engineering & Applied Science, University of Rochester
• Website: Link

Integration/Lead Engineer

• Lead team of 9 engineers to align priorities, and create plans to meet business objectives. 
• Provide technical and risk management guidance for decision making to support ongoing manufacturing activities. 
• Assist with planning of future projects, budgeting, and forecasting of resources.
• Partner with HR to encourage and facilitate the development of the engineering team.

Her prior role at Gore as an Engineer involved: 

• Drove the investigation and corrective action of a failure mode based on complaints from the field. Tested and implemented new solution by facilitating discussions and decisions among multi-disciplinary teams. Documented activities in accordance with the Design Control Process for Class III medical device. 
• Wrote and executed IQ, OQ, POQ, and PQs for new and existing equipment and processes.
• Assess Fitness for Use and clinical impact of anomalies observed in Manufacturing and Quality Control and document in appropriate Quality System object (NCRs, CAPAs, Field Investigations, etc).
• Determine root cause of returned devices from the field and impact of observed failure modes.
• Assist new product development efforts by drafting verification protocols and testing new designs.

• Location: W. L. Gore & Associates, Phoenix, Arizona
• Website: Link

PhD Candidate

Her background includes in vitro models of the arm vasculature and arteriovenous fistulas for hemodiaysis access and biomedical device design. She is currently assisting in the development of an integrated clinical tool which aids physicians by providing detailed hemodynamic profiles of unruptured aneurysms.

• Location: Mechanical Engineering, University at Buffalo
• Website: Link