field_job_employment_type

field_job_occupational_field_parents_all

job_organization_name

city

state

<h3>Job Description</h3>
Job DescriptionJob Description 
Mandatory skills : Embedded Device Testing,Medical devices, Python,Pytest
Job Summary 
We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects.
Key Responsibilities 
Test Planning and Design
Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.
Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.
Test Execution 
Execute manual and automated tests to identify software application defects.
Conduct regression testing to ensure existing functionalities remain unaffected by new changes.
Perform exploratory testing to uncover potential issues not identified by formal test cases.
Documentation and Reporting 
Document test results, including detailed descriptions of defects and steps to reproduce them.
Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.
Communicate test outcomes and defect status to development teams and management.
Collaboration 
Work closely with software developers, and systems engineers, to understand software requirements and functionality.
Compliance and Standards
Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
Stay updated with industry best practices and evolving regulatory requirements for medical device software.
Qualifications 
Education 
Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
Experience 
Minimum of 5+ years of experience in software testing, preferably in the medical device industry.
Experience with testing tools and frameworks (e.g., ClearQuest, Jama).
Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Skills and Competencies 
Strong understanding of software development and testing methodologies.
Excellent analytical and problem-solving skills.
Attention to detail and a high level of accuracy.
Proficiency in scripting or programming languages (e.g., Python, Java) for test automation.
Good communication and teamwork skills.
Regards,
Mohammed ilyas,
PH - 229-264-4024 or Text - 229-469-1455 or You can share the updated resume at Mohammed@vtekis. com
Additional Information 
All your information will be kept confidential according to EEO guidelines.

Verification Engineer with Medical Domain experience and python

<h3>Job Description</h3>
Job Description
CFD Research Corporation is adding a talented Software Engineer to our current team for customer site support in Huntsville, AL. In this role, the Software Engineer will play a critical technical role in the reverse engineering and exploitation of threat systems, which includes the decompiling binary of executable files to source code to extract the underlying algorithms, communications, I/O architecture, message/data formats, and system component architecture. The candidate will also assist the engineering team in the analysis of the threat system performance characteristics, capabilities, and limitations and develop analysis tools to facilitate the reverse engineering process. The foreign material exploitation derived software is then rehosted in a threat-realistic virtual environment, using intelligence informed modeling, and simulation to surrogate missing components.
Basic Qualifications:
<ul>
<li>B.S. in Computer Science, Computer Engineering, Data Science or related technical degree</li>
<li>Five (5) plus years experience performing software development in Windows and Linux environments using compiled languages such as C/C++, Java, and/or Fortran.</li>
<li>Proficiency in MATLAB and Python</li>
<li>Proficiency in Assembly Languages</li>
<li>Proficiency in C/C++</li>
<li>Position requires strong analytic skills, and interest/experience in radar, missile, and/or directed energy weapon topics</li>
<li>The candidate should be familiar with the fundamentals of distributed version control for software development.</li>
<li>Candidate must be a U.S. Citizen</li>
<li>**REQUIRED** Active TS/SCI clearance</li>
</ul>
 
Preferred Qualifications:
<ul>
<li>Experience in Embedded systems and/or Embedded software development (e.g. x86, x64, or RISC, ARM, and microcontrollers)</li>
<li>Experience with software reverse engineering tools (e.g. Autopsy, IDA Pro, Ghidra)</li>
<li>Experience with virtualization and emulation tools (e.g. VMware, VirtualBox, QEMU)</li>
<li>Experience with distributed systems architecture and computer networking</li>
<li>Experience in programming associated with Field Programmable Gate Arrays (FPGAs)</li>
<li>Experience with Digital Signal Processing (DSP) design or modeling and analysis of Software Defined Radios (SDRs)</li>
<li>Knowledge of military systems (e.g. missiles, C4ISR, radars)</li>
<li>Proficiency in Python or other scripting language</li>
<li>Proficiency in SQL</li>
<li>TS/SCI clearance with recent poly is preferred</li>
</ul>
 
Location: This role is based at Redstone Arsenal, in the Huntsville, AL area and is 100% onsite. 
 
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

Threat Modeling Software Engineer

<h3>Job Description</h3>
Job Description
PRIMARY FUNCTION
 
Lumenis is a World Leader Medical Laser and RF energy Treatment Devices provider.
This position provides technical support and training to Lumenis field engineers, sales, customers, and bio-med personnel on problems with diverse scope and complexity. Support is provided in the form of direct telephone, Email, Whats App, Facetime, connect Wise, and Team Viewer. Remote Diagnostics is a key objective. Performs hands on diagnostics, troubleshooting, and repairs on company owned and customer owned Lumenis products at our Service Center located in Salt Lake City, UT. Periodic site visits for servicing will be required. Candidate is required to recommend methods, techniques, parts, and solutions to help field personnel achieve the efficient, effective outcomes. Planning, implementation, and follow up of product technical training is a primary job responsibility.
 
ESSENTIAL DUTIES &amp; RESPONSIBILITIES:
<ul>
<li>Responsible for providing technical support to field engineers and customers who are diagnosing, troubleshooting, repairing, and providing routine servicing on complex Medical Laser, electro/optical, and RF systems.</li>
<li>Must support Customer LAN issues as they interface with Lumenis Devices.</li>
<li>Must be able to remotely troubleshoot and assist customers online with Lumenis proprietary SW Applications utilizing Team Viewer and Connect Wise.</li>
<li>Provides emergency after-hours support when necessary.</li>
<li>Conducts technical product training to Lumenis employees and approved bio-medical engineers for service purposes.</li>
<li>Performs reliability and performance trend analysis as directed. They may be required to provide detailed written reports supported by data to demonstrate cause and affect relationships and propose corrective actions.</li>
<li>Supports service strategy, process development, continuous improvement, and regulatory compliance initiatives.</li>
<li>Works and communicates effectively in a cross-functional environment including, but not limited to US and Global Service Organization (GSO), Sales, Clinical, Engineering, Operations, and Regulatory.</li>
</ul>
QUALIFICATIONS:
The ideal candidate will have a minimum of 3 years of prior experience with a medical device company or Military experience specializing in capital equipment. A technical degree is required; BSEE with experience or training in laser/electro-optics is desirable.
 
COMPETENCIES:
Analysis and Problem-solving
Professional demeanor, composure, and interpersonal skills. Excellent written communication skills.
PC proficiencies, including applications or equivalencies with Microsoft Office Suite, SAP, Sales Force, Service Max CRM, and Team Viewer.
Windows 10 and LAN configuration experience
Technical aptitude with electronics, mechanics, PC controllers, and optics systems.
The job description outlined above reflects general details as necessary to describe the primary functions of this job, the level of knowledge and skill typically required, but should not be construed as an all-inclusive listing of work requirements. Individuals may be asked to perform duties other.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or based on disability, gender identity, or sexual orientation.
 Job Posted by ApplicantPro

Medical Device Technical Support Engineer - Salt Lake City

<h3>Job Description</h3>
Job Description
POSITION: Design Assurance Engineer FULLTIME: ASAP start with 12-month contract (potential temp to hire based on performance) LOCATION: Chandler, AZ (hybrid Mon &amp; Fri work from home) SCHEDULE: Monday - Friday; 8:30am - 5pm PAY RANGE: $44.54 - $56.87/hr paid weekly
Details: 
The Design Assurance Engineer will interface with R&amp;D and other supporting cross-functional teams on developing and maintaining medical equipment, including software and cybersecurity elements. Design assurance drives the ISO 14971 risk management process, Verification &amp; Validation (V&amp;V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems/procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality-related issues. Actively participate in all aspects of Design Control, including capital equipment, systems, and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Key Responsibilities: • Support the execution and documentation of Design Validation &amp; Verification and Usability activities. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications). • Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs). • Lead and support cross-functional root-cause analysis investigation and resolution activities • Evaluate and support design test and inspection method development, and lead method validation activities • Support regulatory submissions to notified bodies. • Understanding of technologies incorporated into design. • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Minimum Qualifications: • Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering. • 2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience • Problem solver, capable of facilitating the problem-solving process • Adaptable and effective collaborator in a team environment and in self-directed work • Strong communication skills (verbal &amp; written) • Ability to work in a highly matrixed and geographically diverse business environment • Demonstrated use of Quality tools/methodologies Preferred qualifications: • Previous Software or Capital equipment Design Assurance experience is a plus • Medical device or other regulated industry experience • Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304) • Experience with 60601, software and cybersecurity • Experience working in an Agile environment
Working Conditions: 
 
<ul>
<li>May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.</li>
<li>The ability to lift up to 30lbs.</li>
<li>Use of computers and technology</li>
</ul>
Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity; we are made a stronger organization and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life. Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans. For individuals with disabilities who would like to request an accommodation, please email our HR team <a href="mailto:hr@canonrecruiting.com" target="_blank">hr@canonrecruiting.com</a>

17577-1 Design Assurance Engineer- Maple Grove, MN (hybrid)

<h3>Job Description</h3>
Job Description
Location: Somerville, MA
Senior Mechanical Engineer – Medical Device
Overview:
Micro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy. Our company has extensive expertise in precision implantable medical devices for nerve stimulation and neuromodulation.
Role Summary:
The primary role of this position is to design and build injectable electrodes for needle delivery and implantable pulse generator housings for next-generation neurostimulator devices. The individual will design electrodes for stimulation and nerve recordings.&nbsp; In addition, the candidate will prototype, build, and conduct mechanical integrity and related tests. The individual will also develop manufacturing processes and work with vendors to manufacture components.
The candidate must have significant background in medical device development, implantable electrodes, process development, and verification and validation. The individual should be hands-on and have direct experience working with vendors and design transfer to contract manufacturers.
Responsibilities:
<ul>
<li>Mechanical design of implantable electrodes for neuromodulation&nbsp;</li>
<li>End-to-end development of assembly and manufacturing processes</li>
<li>Design of processes for thin substrate laminations and bonding techniques</li>
<li>Design of microscale assembly techniques, including scaling to manufacturability</li>
<li>Develop micro-molding, thermoforming, and lamination methods for thin substrates and catheters</li>
<li>Create 3D assemblies and technical drawings of electrodes and implantable housings using SolidWorks and AutoCAD</li>
<li>Identify, source, and manage vendors to obtain hardware components on a schedule (e.g. procuring materials, services from machine shops or 3D printing houses, contract manufacturing)</li>
<li>Develop mechanical testing structures and set up accelerated lifetime tests</li>
<li>Manage engineering personnel as necessary (e.g. junior engineers, technicians, co-ops)</li>
<li>Adhere to Micro-Leads quality management system, understands essential regulatory requirements, and follows standard operating procedures</li>
<li>Maintain design control requirements related Micro-Leads’ QMS including developing design inputs/outputs, risk management, verification and validation</li>
</ul>
Minimum qualifications:
<ul>
<li>B.S. in Mechanical or Biomedical Engineering, M.S. Preferred</li>
<li>2-4 years of related professional experience post-Bachelor’s Degree</li>
</ul>
Desired qualifications &amp; experience:
<ul>
<li>Successful candidates must be able to multi-task and work effectively as part of a small team</li>
<li>Successful candidates will have excellent benchtop capability including the dexterity to manipulate small structures under a stereomicroscope</li>
<li>Familiarity with standard tooling for rapid prototyping (e.g. drill presses, saws, welding, soldering, CNC mills)</li>
<li>Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, casting, micro-fluidic molding, etc.</li>
<li>Experience with Class III implantable systems and hermetic manufacturing methods</li>
<li>Experience with precision microscale assembly of silicone electrodes using processes such as injection molding, thermoforming, lamination, micro-molding, etc.</li>
</ul>
Benefits:
<ul>
<li>Medical Insurance</li>
<li>Dental Insurance</li>
<li>Vision Insurance</li>
<li>Stock Options</li>
</ul>
Company DescriptionMicro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy. Our company has extensive expertise in precision implantable medical devices for nerve stimulation and neuromodulation. 
<h3>Company Description</h3>
Micro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy. Our company has extensive expertise in precision implantable medical devices for nerve stimulation and neuromodulation.

Senior Mechanical Engineer - Medical Device

<h3>Job Description</h3>
Job Description
CFD Research is seeking a Senior level Engineer to serve as a technical lead on a project focused on the development and application of computational methods for high-speed (hypersonic) vehicle modeling and simulations. The candidate will be part of a team focused on physics-based modeling of multiple facets of hypersonic flight, including TPS aerothermal response, boundary layer modeling, material ablation and decomposition, hypersonic external flow modeling, flight trajectory modeling, thermo-structural response modeling, and more. 
Candidate will support tasks focused on the development and application of multiple software tools ranging from CFD applications, reduced order modeling, and low- to medium-fidelity semi-empirical / analytical models. The position provides an engaging work environment with excellent opportunities for growth and advancement as the hypersonic research and development portfolio of the team continues to grow.
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 Master or PhD in Aerospace or Mechanical Engineering (or related STEM discipline) and at least five years of relevant experience</li>
<li>Experience in execution of physics-based M&amp;S CFD codes, aerothermal codes, or other relevant multi-physics codes</li>
<li>Candidate must have experience in compiled languages such as Fortran and/or C/C++ and knowledge of code compilation and development on Linux</li>
<li> Demonstrated verbal and written communication skills is required</li>
</ul>
Desired Qualifications:
<ul>
<li> An active secret level security clearance</li>
<li>Experience developing codes for modeling and simulation for engineering applications</li>
<li>Experience with key aspects of hypersonic system modeling such as: hypersonic boundary layer and heat transfer modeling, ablation, non-equilibrium thermodynamics, chemistry modeling, turbulence, etc.</li>
<li> Experience with surrogate modeling, reduced order modeling, UQ, and / or optimization</li>
</ul>
Location: This role is based in Crane, IN area, and is 100% onsite.
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 three of last four 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 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

Senior Research Engineer - High-Speed Modeling and Simulation - Crane, IN

<h3>Job Description</h3>
Job Description
Nova Biomedical is hiring a Manufacturing Engineer Ill on-sitein our Manning Rd, Billerica, MA facility on the second shift (3:00 PM – 11:00 PM - This includes a 10% shift differential). . As the Manufacturing Engineer III you will provide technical support for all Test Strip Manufacturing operations regarding various processes and assembly issues. You will contribute to or lead development, design and the validation of existing and start up manufacturing equipment or processes as well as work with Advanced Manufacturing providing concurrent engineering and process for development for smooth transfer of new products/processes into manufacturing. Other Responsibilities include:
<ul>
<li>Writing and updating the support documentation (APs, TPs, and OIs) for the process, developing, writing and performing IQ, OQ and VQs used in the manufacturing of Test Strips</li>
<li>Performing engineering studies and analyses on existing manufacturing processes to improve process reliability, problem solving, or improving product quality or cost.</li>
<li>Designing or purchasing tooling and equipment</li>
<li>Using appropriate statistical techniques to develop and complete process capability studies</li>
<li>Actively participating in other team activities to help ensure total team success</li>
<li>Taking an active role in learning for self and others to further company objectives</li>
</ul>
More specific responsibilities will include:
Floor Support
<ul>
<li>Main responsibility is to provide technical support for all the manufacturing process equipment.</li>
<li>Responsible for writing and updating the support documentation for the process</li>
<li>Work with the Manufacturing Engineers and direct technicians to assist in troubleshooting and maintaining the manufacturing process equipment.</li>
</ul>
Prototype Build
<ul>
<li>Participation in design reviews on new products during development phase.</li>
</ul>
Pilot &amp; Production Build
<ul>
<li>Manage technical resources consisting of engineers/technicians in the transfer of new processes and assemblies to manufacturing as well as providing cost estimates, creating work breakdown structures, creating/maintaining project schedules, providing project status reports, presentations of concerns/accomplishments to team and upper management.</li>
<li>Manage the various functions of projects for proper implementation that meets all regulatory guidelines including the creation and performance of Installation, Operational &amp; Performance Qualifications, Process Validations and Failure Mode Effects Analysis (FMEA).</li>
</ul>
Technical Functions
<ul>
<li>Prioritize technical floor issues to resolve in a timely and efficient manner.</li>
<li>Design fixtures and necessary tooling for processes or modifications to equipment as needed. This includes researching and finalizing specifications for capital equipment as well as supplier quote comparison and ROI analysis.</li>
<li>Manage activities for continuous improvement to reduce product cost and cycle times.</li>
<li>Create new manufacturing documentation and updating/enhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.</li>
<li>Review and implementation of lean manufacturing techniques.</li>
<li>Investigation of returned items from the field to determine root cause and implementing corrective/preventative actions to prevent reoccurrence.</li>
</ul>
Training
<ul>
<li>Train and or oversee the training of employees on new products, equipment, and processes.</li>
<li>Document training records.</li>
<li>Demonstrate the use of the equipment to visitors.</li>
</ul>
Qualifications/Skills and Competencies:
<ul>
<li>Must be proficient with Microsoft Office, (Solidworks and/or AutoCAD programs.</li>
<li>Must have strong written and oral communication skills.</li>
<li>Knowledge of FDA QSR's and ISO regulations is helpful.</li>
</ul>
Education/Experience:
<ul>
<li>B.S in Mechanical Engineering/Biomedical/Electromechanical Engineering with 5-10 years of experience in the Biomedical or High Volume manufacturing field.</li>
<li>Must have experience maintaining and troubleshooting complex high volume automated manufacturing equipment.</li>
<li>Experience with vision inspection systems, electronics, pneumatics and machine control systems a plus.</li>
</ul>
At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, and an innovative scholarship program for children of employees.

Manufacturing Engineer III (2nd Shift 3:00 PM - 11:00PM)

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;X,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube,&nbsp;LinkedIn&nbsp;and&nbsp;Tik Tok.
Job Description 
We are looking for a Senior Device Engineer who has experience in development of electromechanical devices/combination products primarily with a Software Engineering or Electrical Engineering background to join our Device Engineering team in Combination Product Development, R&amp;D. This individual will contribute to the development of exciting new drug/device combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development.&nbsp;
Within Combination Product Development, the Product Engineering team is responsible for developing products informed by user needs and product requirements, completing feasibility assessments (including prototyping and lab testing), and ultimately supporting design and verification activities that result in safe and effective devices. These devices enable the delivery of AbbVie’s innovative medicines across a broad range of therapeutic areas and routes of administration; the resulting combination products target difficult-to-treat diseases with the goal of making a remarkable impact on people’s lives.&nbsp;
You would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. The problems you would help to solve relate not only to the function of innovative electromechanical devices, but also the way in which they interact with drug products and the human body. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of developing solutions to tough health challenges, this opportunity might be for you.&nbsp;
This position is based in Lake County, IL, US.&nbsp;
Responsibilities:&nbsp;
<ul>
<li>
Feasibility assessments, including prototyping, analysis, and lab testing&nbsp;
</li>
<li>
Definition and execution of engineering confidence test plans and design margin assessment&nbsp;
</li>
<li>
Development of User Interface and translation of user workflow to software requirements&nbsp;
</li>
<li>
Ability to understand software and hardware architectures, modules, and interfaces&nbsp;
</li>
<li>
Understand and support system reliability studies from electrical hardware perspective (e.g. battery life, power budget over service life, etc.)&nbsp;
</li>
<li>
Planning for Design outputs and ownership of Design Output Reviews&nbsp;
</li>
<li>
Design Verification support including design and execution of tests using automated tests tools and manual test development (test method development, issue resolution)&nbsp;
</li>
<li>
Assisting the development team in troubleshooting and solving issues, including developing hardware and software tools to advance root cause investigations&nbsp;
</li>
<li>
Assessment of compliance to international standards and regulatory requirements for software and medical devices including cybersecurity; support documentation to ensure compliance&nbsp;
</li>
<li>
Collaborating with external global manufacturing and development partners&nbsp;
</li>
<li>
This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.&nbsp;&nbsp;
</li>
<li>
Contribute to raising the bar on how we develop combination products.&nbsp; This includes the identification and leadership of improvement initiatives, generating new ideas and connecting unrelated concepts to spark innovation for our products and processes.&nbsp;&nbsp;&nbsp;
</li>
<li>
Some travel required&nbsp;
</li>
</ul>
Qualifications 
<ul>
<li>
BS in Software Engineering, Computer Science, Electrical Engineering, or Biomedical Engineering with 8+ years of experience or MS with 6+ years of experience (MS preferred)&nbsp;
</li>
<li>
Experience must include significant device development, with medical device, pharmaceutical or other regulated industries preferred&nbsp;
</li>
<li>
Experience developing software for a range of electromechanical or medical devices, preferably in the drug delivery space&nbsp;
</li>
<li>
Familiarity with electrical schematics and system design&nbsp;
</li>
<li>
Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485), Medical Device Software Lifecycle (ISO 62304), and Risk Management (ISO 14971)&nbsp;
</li>
<li>
Strong communication skills (both written and verbal) including the ability to influence without direct authority&nbsp;&nbsp;
</li>
<li>
Strong device design and analytical skills&nbsp;
</li>
<li>
Proficiency in tolerance analysis and descriptive statistics&nbsp;
</li>
<li>
Ability to create and manage schedules for sub-tasks and work streams for which you are responsible&nbsp;
</li>
<li>
A keen eye for identifying project goals and risks, and proactively developing implementation and mitigation plans  &nbsp;
</li>
<li>
Ability to multitask and work within timelines.&nbsp;
</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&nbsp;local law:&nbsp;​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company&nbsp;believes in&nbsp;good faith it will pay for this role at the time&nbsp;of this posting based on the job grade for this position.&nbsp;Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and&nbsp;we&nbsp;may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the&nbsp;future.​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&nbsp;medical/dental/vision&nbsp;insurance and 401(k) to eligible&nbsp;employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive&nbsp;programs.&nbsp;​
</li>
<li>
This job is eligible to participate in our long-term incentive&nbsp;programs​
</li>
</ul>
​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and&nbsp;determinable.&nbsp;The amount and availability of any bonus,&nbsp;commission, incentive, benefits, or any other form of&nbsp;compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and&nbsp;absolute&nbsp;discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with&nbsp;applicable law.&nbsp;
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.&nbsp; It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html&amp;nbsp" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>;
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

223 biomedical engineer Jobs