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<h3>Job Description</h3>
Job Description
About Us
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.
Job Summary
BrioHealth Solutions Inc. is seeking a Design Quality Engineer to support QA compliance activities for an active implantable medical device. This exempt-level role is critical in ensuring the quality, safety, and regulatory compliance of our medical devices throughout the design and development lifecycle.
As a Design Quality Engineer, you will lead and oversee quality engineering principles, design control processes, and risk management strategies to drive the success of our innovative products. Your expertise will help ensure that our devices meet industry standards, regulatory requirements, and internal quality objectives from concept to manufacturing.
 
Responsibilities
<ul>
<li>Design Control &amp; Compliance
<ul>
<li>
Ensure adherence to design control processes across the entire product development lifecycle, including planning, design inputs/outputs, verification, validation, and transfer to manufacturing.
</li>
<li>
Develop and maintain comprehensive design control documentation, including design plans, risk management files, and verification/validation reports.
</li>
<li>
Conduct and facilitate design reviews to assess compliance with regulatory standards, industry best practices, and internal quality procedures.
</li>
<li>
Apply risk management methodologies (ISO 14971) to identify, evaluate, and mitigate risks associated with medical device design and usage.
</li>
</ul>
</li>
<li>Risk Management &amp; Quality Assurance
<ul>
<li>
Lead risk assessment activities, including developing and maintaining risk management files, risk analyses, and risk control plans.
</li>
<li>
Collaborate with engineering teams to integrate risk management principles into the design process and facilitate risk-based decision-making.
</li>
<li>
Establish and maintain quality assurance processes to ensure compliance with ISO 13485, FDA QSR, and other applicable regulations.
</li>
<li>
Conduct internal audits and assessments to verify compliance with quality management system requirements.
</li>
<li>
Perform statistical analysis and trend monitoring of quality data to identify improvement areas and implement corrective and preventive actions (CAPAs).
</li>
</ul>
</li>
<li>Supplier &amp; Regulatory Support
<ul>
<li>
Collaborate with suppliers to ensure their processes and products meet required quality standards and regulatory expectations.
</li>
<li>
Participate in supplier audits and assessments, addressing any non-conformances or quality concerns.
</li>
<li>
Support supplier qualification and selection by evaluating their quality systems, capabilities, and performance.
</li>
<li>
Stay up to date with regulations, guidelines, and industry best practices in medical device design, development, and quality assurance.
</li>
<li>
Assist in preparing and submitting regulatory filings, including Investigational Device Exemptions (IDE), Pre-Market Approvals (PMA), 510(k) submissions, technical files, and design dossiers.
</li>
<li>
Support regulatory inspections and audits, addressing any findings and implementing necessary corrective actions.
</li>
</ul>
</li>
</ul>
 
Qualifications
<ul>
<li>
Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field); an advanced degree is a plus.
</li>
<li>
7+ years of experience in the medical device industry, with a focus on design quality engineering or related roles.
</li>
<li>
Strong knowledge of design control processes, risk management principles, and quality management systems (ISO 13485, FDA QSR).
</li>
<li>
Familiarity with medical device regulatory standards, including FDA regulations, ISO 13485, EU MDR, and ISO 14971.
</li>
<li>
Proficiency in applying statistical methods and tools for data analysis and quality improvement.
</li>
<li>
Excellent problem-solving skills, with the ability to make data-driven decisions.
</li>
<li>
Strong communication and collaboration skills, with the ability to work cross-functionally.
</li>
</ul>

Design Quality Engineer

<h3>Job Description</h3>
Job Description
Job Title: Software Verification Engineer I
Location:St. Paul, MN 55117 - Onsite
Duration: 06 Months Contract with possible extension
Shift/Schedule: 8:00 AM – 4:00 PM 
Pay Rate: $35.00/hr on w2 w/o benefits.
Job Description:
<ul>
<li>100% manual testing, configuring test equipment, and managing the lab.</li>
<li>Degree in computer science, EE, or Biomedical required</li>
<li>EnSite X Mapping System currently used – experience helpful, not required</li>
<li>Microsoft Office experience required</li>
<li>Ability to follow SOPs</li>
<li>6-week training program</li>
<li>1 to 2 years medical experience highly preferred</li>
</ul>
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities 
<h3>Company Description</h3>
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Software QA Engineer I

Software Verification Engineer I

<h3>Job Description</h3>
Job Description
Job Summary:
This role will lead project teams and contribute technically across all phases of innovation, design, and development for low-power, mixed-signal, and analog integrated circuits. These circuits are crucial for life-critical implantable medical devices, guiding them from market definition through release and ongoing maintenance.
This position will work across multiple disciplines, extending beyond integrated circuit design to areas like research, marketing, clinical, regulatory, manufacturing, quality, and testing. Success will be measured by the timely delivery of integrated circuits that meet critical clinical and business needs while exceeding industry standards for reliability and quality. Key responsibilities include using state-of-the-art CAD tools for the design, simulation, integration, and verification of integrated circuits and systems. This role will collaborate directly with system hardware, software, and clinical engineering teams, as well as medical consultants, and work closely with IC design, test, and layout engineers in both US and international design centers.
Responsibilities:
<ul>
<li>Design and development of high-performance and high-reliability ultra-low power analog/mixed signal integrated circuits for implantable medical products.</li>
<li>Active involvement in all aspects of IC design, including the development of functional concepts and specifications, top-level design architecture, design partitioning and block-level design, detailed circuit design and simulation, layout floor-planning and transistor-level layout, bench verification and testing, test-vector development, and documentation.</li>
<li>Design of novel, robust, ultra-low power, low-voltage analog/mixed-signal IC functional blocks, including but not limited to voltage/current references, operational amplifiers, comparators, switched-capacitor circuits (amplifiers, filters, charge pumps, etc.), ADCs and DACs, oscillators, switching power circuits, communication circuits, etc.</li>
<li>Design of ultra-low power digital functional blocks (combinatorial, sequential, synchronous, asynchronous, state machines, etc.) for timing, control, interfacing, and signal processing.</li>
<li>Create behavioral models for modules and system level verification models for circuits. Perform pre-silicon verification and post-silicon validation of circuits. Collaborate with IC Test group to define production vectors.</li>
<li>Consult with physicians, clinical research, published literature, and technology leaders on new and existing technologies, trends, and requirements for their use.</li>
</ul>
Education and Experience:
<ul>
<li>Advanced degree in Electrical Engineering (MS / PhD) with additional background in biomedical engineering, physiology, biology, and/or business principles with demonstrated expertise in fundamental electrical engineering, circuit, and systems principles, and closed-form analytical approaches.</li>
<li>Self-motivated independent thinker able to apply industry research and personal experience to design proposals, combined with strong verbal communications skills and strong technical document writing skills.</li>
<li>8+ years of experience in analog/mixed-signal IC design for very low power portable and/or implantable applications, with a strong grasp of the tradeoffs involved in using various analog and digital circuit design techniques (RTL or schematic-based) to optimally implement system functions.
<ul>
<li>Preferred: 5+ years implantable medical device industry experience including FDA regulated design controls and product approval process.</li>
</ul>
</li>
<li>Deep understanding of CMOS processes, device characteristics and models, transistor level circuit analysis and design concepts and trade-offs: BW, noise, power, feedback analysis, stability etc., worst case process corners, margin and Monte Carlo analysis, and design-for-test.
<ul>
<li>Preferred: Knowledge of low power flows, including voltage/power domains, power shutoff, retention is desired</li>
</ul>
</li>
<li>Solid understanding of circuit building blocks (op-amps, comparators, voltage and current references, DACs, ADCs,) and layout techniques for ultra-low power design to deliver robust, production quality silicon designs.
<ul>
<li>Preferred: Experience with medical domain specific designs such as neuromodulation, charging, low noise biomedical signal measurement and processing, battery energy conversion techniques, and very low power RF communication circuits.</li>
</ul>
</li>
<li>Extensive working knowledge and use of Cadence mixed signal Design tools, Virtuoso XL, Spectre, Xcelium/AMS simulators along with Maestro, and other mixed signal signoff tools for analog regression testing.
<ul>
<li>Preferred: Knowledge of scripting/language (perl, shell, tcl, python) along with C/C++, as well Matlab is desirable</li>
</ul>
</li>
<li>Experience in lab bench characterization and test-vector generation for pre-silicon and post-silicon verification, design-for-manufacturing test vector generation, production support, fault isolation and failure analysis, and pre-clinical and clinical testing environments.</li>
<li>The successful candidate would demonstrate industry recognition of technical accomplishments in the form of patents and/or published articles.
<ul>
<li>Preferred: Experience with international teams and a working knowledge of German would be highly desirable.</li>
</ul>
</li>
</ul>

Staff/Principal Mixed Signal IC Design Engineer

<h3>Job Description</h3>
Job Description
Job Duties:
<ul>
<li>Provides R&amp;D support for market-released cardiovascular catheters.</li>
<li>Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.</li>
<li>Develops solutions to improve product function and manufacturability.</li>
<li>Directs support personnel and coordinates project activities.</li>
<li>Write and submit Engineering Change orders.</li>
<li>Maintains detailed documentation throughout all phases of development.</li>
<li>Investigates and evaluates design changes, manufacturing changes, NCMRs, CAPAs and/or customer complaints.</li>
<li>Reviews or coordinates vendor activities to support development.</li>
<li>Researches various cost-effective, alternative approaches to current designs and processes.</li>
</ul>
Qualifications:
<ul>
<li>Education: Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience</li>
<li>Experience: 2+ years of related work experience with a complete understanding of specified functional area</li>
<li>Skills: Prior medical device engineering experience in R&amp;D preferred</li>
</ul>
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort. Browse our website below for additional information on our company. The Fountain Group 4505 Woodland Corporate Blvd, Tampa, FL 33614 “We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.” 
<h3>Company Description</h3>
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r\n\r\nBrowse our website below for additional information on our company.\r\n\r\nThe Fountain Group\r\n\r\n4505 Woodland Corporate Blvd, Tampa, FL 33614\r\n“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

Research and Development Engineer

<h3>Job Description</h3>
Job Description
About Ceribell
Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography ("EEG") platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!
Position Description:
 Ceribell is looking for a Staff Embedded Software Engineer who is passionate about biomedical applications and who has experience in the development of embedded Linux-based products. The successful candidate will join the R&amp;D team and will play a key role in the development of the next generation of Ceribell's life saving technologies. You must be able to work collaboratively as part of a cross-functional R&amp;D team, but you must also be able to take individual ownership for development, testing, and documentation of your projects.
Responsibilities:
<ul>
<li>Develop and test software features for Ceribell's EEG systems.</li>
<li>Understand user needs and translate them to the development of new and improved features.</li>
<li>Participate in code reviews, peer reviews, and risk management activities.</li>
<li>Create and revise technical documentation.</li>
<li>Provide input on firmware and hardware architecture for new and existing products.</li>
</ul>
Requirements/Qualifications
<ul>
<li>Bachelor's Degree in electrical engineering, computer science, biomedical engineering or related field. Graduate degree preferred.</li>
<li>8+ years of experience in embedded software development of a commercial product. Medical device experience preferred.</li>
<li>Proficient in C/C++.</li>
<li>Experienced with software development, interfacing with peripherals, and configuring device drivers in embedded Linux-based systems and associated toolchains, e.g. Ubuntu, Torizon, Yocto, Buildroot.</li>
<li>Experience with bootloaders, kernel debugging, and optimization for linux system</li>
<li>Experience with GUI-based application development in e.g. Qt preferred.</li>
<li>Experienced using Git for version control.</li>
<li>Direct experience with development of WiFi connected/IoT devices preferred.</li>
<li>Strong analytical skills, detail-oriented and collaborative.</li>
</ul>
A candidate's final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell's corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.
Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Any applicant with a disability who requires an accommodation during the application process should contact <a href="mailto:talent@ceribell.com" target="_blank">talent@ceribell.com</a> to request reasonable accommodation.
 In addition to your base compensation, Ceribell offers the following:
<ul>
<li>Annual Bonus Opportunity + Ceribell Equity </li>
<li>100% Employer paid Health Benefits for the Employee</li>
<li>50% - 70% Employer paid Health, Dental &amp; Vision for dependents (according to plan selection)</li>
<li>Life &amp; Long-term disability insurance paid 100% by Ceribell</li>
<li>Monthly cell phone stipend</li>
<li>Flexible paid time off</li>
<li>11 Paid Holidays</li>
<li>Excellent parental leave policy</li>
<li>Fantastic culture with tremendous career advancement opportunities</li>
<li>Joining a mission-minded organization!</li>
</ul>
Compensation Range$174,000—$193,000 USD

Staff Embedded Software Engineer

<h3>Job Description</h3>
Job Description
CFD Research Corporation is seeking a Mechanical Engineer to join our team and play a pivotal role in the design, development and integration of complex systems for our customers. This position is a new role that will work on a growing team of engineers and technicians and will encompass conceptual design, prototyping, and testing in support technology development programs designed and prototyped at our new Hollywood, Alabama Engineering Test Center, located a short distance from our Headquarters in Huntsville, AL. To learn more about the Hollywood Engineering Test Center capabilities and state-of-the-art equipment, please visit the facility's home page: <a href="https://www.cfd-research.com/hollywood/" target="_blank">https://www.cfd-research.com/hollywood/</a> The ideal candidate will have experience working engineering tasks related to concept development, design, fabrication, and prototyping hardware. One challenge for this opening will be to help facilitate functionality between the engineering team and production/prototyping facility. Previous experience in an AS9100 environment is preferred. The candidate should be comfortable interacting with multiple stakeholders, including the government customer. This position will require a driven individual with a common-sense approach to hardware engineering and a passion for building/making/testing technologies.
Basic Qualifications:
<ul>
<li>Candidate must be a US Citizen and meet eligibility to obtain (and maintain) a Secret Clearance</li>
<li>Position requires a Bachelor's Degree in Mechanical or Aerospace Engineering (or similar STEM discipline) and at least 5 years of relevant experience</li>
<li>Experience designing and developing prototype hardware</li>
<li>SolidWorks or other CAD experience</li>
<li>Designing for manufacturing methods including milling and turning operations</li>
</ul>
Desired Qualifications:
<ul>
<li>Familiarity with AS9100 process </li>
<li>Generation of Technical Data Packages (TDP)</li>
<li>Interpreting results from CFD and FEA analysis tools to inform design</li>
<li>Experience with aerospace hardware</li>
<li> Experience with CNC machinery</li>
</ul>
Location: This individual will work onsite in Hollywood, AL.
 
About CFD Research: Since its inception in 1987, CFD Research has delivered innovative technology solutions within the Aerospace &amp; Defense, Biomedical &amp; Life Sciences, Intelligence &amp; Sensing, and Energy &amp; Materials industries. CFD Research has earned multiple national awards for successful application and commercialization of innovative component/system technology prototypes, multi-physics simulation software, multi-disciplinary analyses, and expert support services. Based in Huntsville, Alabama where laboratory facilities and headquarters are located, CFD Research also has office and laboratory facilities in Dayton, Ohio, prototyping test and evaluation facilities in Hollywood, Alabama, and office facilities in Fort Walton Beach, Florida. CFD Research is an ISO9001:AS9100D registered company and is appraised at CMMI Level II for Services. CFD Research is a 100% ESOP (employee-owned company) recognized in Inc. Magazine's Inc5000 as a top growing company for four of the last five years. Learn more at <a href="http://www.cfd-research.com" target="_blank">www.cfd-research.com</a>
Benefits: CFD Research offers competitive salaries and excellent employee benefits, including an employer matching 401(k) and Employee Stock Ownership Plan (ESOP). CFD Research offers a highly competitive insurance package, including medical, vision, and dental insurance. We offer company paid leave, compensation time, parental leave, long-term and short-term disability, accidental death and dismemberment, and life insurance. Performance appraisals occur twice a year and annual pay increases are based upon corporate goals, personal development, performance, and outstanding achievements. In addition, group and individual bonuses are awarded for exceptional performance.
CFD Research is an EO employer - Veterans/Disabled and other protected categories
 Job Posted by ApplicantPro

Mechanical Engineer

<h3>Job Description</h3>
DescriptionA Brief Overview
Maintains clinical equipment through the effective use of the Medical Equipment Management Plan. Under direct supervision, inspects, repairs, maintains, and calibrates basic diagnostic imaging equipment, devices, systems and instruments. Serves as front-line responder on those systems and works with clinical staff in the identification of technology-based problems. Participate in on-the-job training programs regarding technical, administrative, and customer service requirements.
Additional Responsibilities
<ul>
<li>Performs other duties as assigned.</li>
<li>Complies with all policies and standards.</li>
<li>For specific duties and responsibilities, refer to documentation provided by the department during orientation.</li>
<li>Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.</li>
</ul>
QualificationsEducation
<ul>
<li>Associate's Degree military training, academic work aligned with AAMI’s Core Competencies for the Biomedical Equipment Technician, or other equivalent education (Required) </li>
</ul>
Work Experience
<ul>
<li>3+ years Experience in electronic, mechanical or electro-mechanical repair in a healthcare related setting (Required) or </li>
<li>1+ years Imaging equipment repair and maintenance within a healthcare related environment (Required) or </li>
<li> Entry level of formalized training and/or equivalent military experience. (Required) and </li>
<li> Substantive experience plus increased levels of training and certification in area of imaging (Required) </li>
</ul>
Knowledge, Skills, &amp; Abilities
<ul>
<li> Understanding of common clinical terminology as well as that of life sciences such as anatomy and physiology (Required proficiency) </li>
<li> Understanding of computers and network architecture. (Required proficiency) </li>
<li> Possesses advanced understanding and skills related to general electromechanical systems and devices as applied to imaging (Required proficiency) </li>
<li> Exhibits a detailed understanding and can fully communicate the use of devices supported (Required proficiency) </li>
<li> Can provide advanced support of acuity equipment for direct patient care (Required proficiency) </li>
<li> Has in-depth understanding of the operations and environment that they support (hospital, etc.) (Required proficiency) </li>
<li> Possesses in depth understanding of common clinical terminology as well as that of life sciences such as anatomy and physiology (Required proficiency) </li>
<li> Is knowledgeable about both local and national public safety and regulatory issues (Required proficiency) </li>
<li> Can successfully support the solution of organization–level customer service issues and complaints, especially those issues that apply to imaging. (Required proficiency) </li>
<li> Has a working understanding of project management terms and methods (Required proficiency) </li>
<li> Demonstrates a working knowledge of clinical radiology systems (Required proficiency) </li>
<li> Has a basic understand of project management terms and methods (Required proficiency) </li>
<li> Has advanced experience in their assigned clinical environment (Required proficiency) </li>
<li> Basic knowledge of mathematics, physics, chemistry, English and professional skills plus increased levels of certification and training as needed (Required proficiency) </li>
</ul>
Licenses and Certifications
<ul>
<li>Certified Radiology Equipment Specialist (CRES) (Preferred) </li>
<li> AAMI - ACI certification (Preferred) </li>
</ul>
Physical Demands
<ul>
<li>Standing Constantly </li>
<li>Walking Constantly </li>
<li>Sitting Rarely </li>
<li>Lifting Frequently 50 lbs </li>
<li>Carrying Frequently 50 lbs </li>
<li>Pushing Frequently 50 lbs </li>
<li>Pulling Frequently 50 lbs </li>
<li>Climbing Occasionally 50 lbs </li>
<li>Balancing Occasionally </li>
<li>Stooping Frequently </li>
<li>Kneeling Frequently </li>
<li>Crouching Frequently </li>
<li>Crawling Occasionally </li>
<li>Reaching Occasionally </li>
<li>Handling Constantly </li>
<li>Grasping Constantly </li>
<li>Feeling Constantly </li>
<li>Talking Constantly </li>
<li>Hearing Constantly </li>
<li>Repetitive Motions Frequently </li>
<li>Eye/Hand/Foot Coordination Frequently </li>
</ul>
Travel Requirements
<ul>
<li>10% </li>
</ul>

Imaging Service Engineer II

<h3>Job Description</h3>
Job DescriptionDEKA Research and Development, housed in Manchester, NH, has an exciting opportunity for a Quality Systems Engineer&nbsp;Intern to work in a dynamic Research and Development environment. In this role you will work alongside a group of passionate engineers to create innovative solutions that truly make a difference. DEKA offers Internships and Co-Ops for full time students* (must be at least 18 years of age). Internships last a minimum of 10 weeks, 12 preferred. All summer internships must start no later than June 16, 2025. How You will Make an Impact as a Quality Systems Engineer Intern: As a Quality Systems Engineer Intern, you’ll help strengthen and improve DEKA’s Quality Management System (QMS). You’ll gain real-world experience working on meaningful projects, including:
<ul>
<li>Designing and testing workflows in the electronic QMS (eQMS) platform</li>
<li>Collecting, analyzing, and trending quality data</li>
<li>Writing and refining SOPs and guidance documents that support QMS processes</li>
<li>Streamlining and formatting quality documents for improved usability and traceability</li>
<li>Collaborating cross-functionally to identify opportunities for continuous improvement</li>
<li>Reviewing SOPs and documentation for alignment with FDA QSRs, ISO 13485, and other regulatory standards</li>
<li>Supporting CAPA investigations using root cause analysis, data-driven insights, and structured problem-solving approaches</li>
</ul>
 What You will Learn as a Quality Systems Engineer Intern: You’ll build a strong foundation in quality systems for medical device development, including:
<ul>
<li>Key design control processes and how they’re applied in real-world product development</li>
<li>Hands-on experience with quality system compliance and regulatory frameworks like FDA QSRs and ISO 13485</li>
<li>Technical writing and document control best practices</li>
<li>Project management and cross-functional collaboration</li>
<li>How to clearly communicate complex technical information across a range of audiences</li>
</ul>
What We Look for in a Quality Systems Engineer Intern:
<ul>
<li>Curiosity &amp; Drive: You’re eager to learn and not afraid to ask questions</li>
<li>Analytical Thinking: You like solving problems and spotting patterns in data</li>
<li>Strong Communicator: You can clearly explain technical ideas</li>
<li>Attention to Detail: You catch what others might miss</li>
</ul>
To be successful in this role you need the following skills and experience:
<ul>
<li>Enrolled in an undergraduate science or engineering program (graduate students are not eligible)</li>
<li>Local to New Hampshire (preferred)</li>
<li>Exposure to or coursework in the following areas is a plus (preferred):
<ul>
<li>Biomedical engineering or design projects</li>
<li>Design controls or medical device regulations (21 CFR Part 820, ISO 13485)</li>
<li>Microsoft Word and Excel</li>
<li>Technical documentation (e.g., lab reports, procedures)</li>
</ul>
</li>
</ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored. &nbsp;
Additional Information:
*Applicants should be aware that short-term housing options in Manchester, NH are limited and that DEKA is not able to financially assist with housing.&nbsp;
Public transportation is available and routes/schedules can be found by visiting the Manchester Transit Authority website,&nbsp;<a href="http://www.mtabus.org" target="_blank">www.mtabus.org</a>.
Please be aware that we try to make sure that our internship opportunities are well defined and will provide a unique experience. We understand that most candidates would like to know if they have a placement as soon as possible, but at DEKA it takes more time than other companies at we review every application that is submitted.&nbsp; We will try to let you know as soon as we can, but encourage you to pursue other opportunities as well.
*A full time student is defined as being enrolled in a minimum of 12 credits per semester at an undergraduate program, or a minimum of 9 credits per semester for a graduate program.
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syfExb5NIl

Quality Systems Engineer- Internship- Summer 2025

<h3>Job Description</h3>
Job DescriptionAbout Zenflow Zenflow, Inc.&nbsp;is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props&nbsp;openthe&nbsp;urethra, restoring its normal function while preserving the natural anatomy.&nbsp;The Zenflow Spring System is an investigational device and is not approved for commercial sale. POSITION OVERVIEW: The Senior R&amp;D Mechanical Engineer will play a critical role in the design, development, and testing of innovative medical devices from concept through commercialization. The ideal candidate has a strong background in mechanical engineering, extensive experience in medical device development, and a passion for solving complex engineering challenges. MAJOR DUTIES AND RESPONSIBILITIES:
<ul>
<li>Innovation and Problem Solving
<ul>
<li>Develop innovative solutions to challenging engineering problems.</li>
<li>Maintain current knowledge of medical, technical, and biomedical developments related to the company’s products.&nbsp; </li>
</ul>
</li>
<li>Mechanical Design and Analysis
<ul>
<li>Use Solidworks to create detailed designs and drawings.</li>
<li>Have overall responsibility for design, sourcing, and documentation of subcomponents and subassemblies for new products or product revisions. </li>
</ul>
</li>
<li>Prototyping, Testing, and Documentation
<ul>
<li>Work with other engineers, machinists, and physicians to create working prototypes, specifications, and drawings for new products or product revisions which are low-cost and easy to manufacture. </li>
<li>Conduct Verification/Validation activities, including product specification and test method development.</li>
<li>Maintain an accurate lab notebook and record of assignments and results.</li>
</ul>
</li>
<li>Vendor Management
<ul>
<li>Manage vendors and their schedules to obtain parts in a cost-effective and expedited manner.</li>
</ul>
</li>
<li>Mentorship
<ul>
<li>Advise junior engineering team on documentation, prototypes, and product development.</li>
</ul>
</li>
<li>Regulatory Compliance
<ul>
<li>Ensure that designs meet all relevant regulatory requirements and standards, including FDA, ISO, and CE. Prepare and review technical documentation to support regulatory submissions.</li>
</ul>
</li>
</ul>
EDUCATION REQUIREMENTS: BS in Mechanical Engineering, Electrical Engineering, or&nbsp;Biomedical engineering. EXPERIENCE REQUIREMENTS: 6+ years of experience as an R&amp;D engineer in the medical device industry. OTHER QUALIFICATIONS:&nbsp;
<ul>
<li>Experience in designing injection-molded components.</li>
<li>Extensive experience with mechanical drawing and Solidworks </li>
</ul>
 The expected salary range for this position is $130,000 - $150,000 plus equity and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
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