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<h3>Job Description</h3>
Job DescriptionSalary: $130k+/yr DOE 
OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr Product Development Engineer (Mechanical) responsible for the development of new products, transitioning products from design phase to production, and providing support for all products in production. This is a hands-on role with work performed in office for effective collaboration and communication.
 
You will:
<ul>
<li>Provide end-to-end design and development of new products per companys design control procedures and QSR requirements in accordance with plans and milestones.</li>
<li>Develop test strategies, plan and facilitate testing. Execute and document product verification and validation testing for compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements and related specifications.</li>
<li>Work closely with suppliers to collaborate on DFM recommendations to optimize cost and quality.</li>
<li>Develop new suppliers, new manufacturing procedures and product enhancements.</li>
<li>Work with manufacturing and quality personnel to develop inspection procedures and processes for new products in compliance with the companys quality system and business goals.</li>
<li>Transition products from concept to design phase through V&amp;V to production.</li>
<li>Communicate progress to project leadership and cross-functional teams in periodic status meetings/reports.</li>
<li>Work closely with Quality, Regulatory, Marketing, Sales and Customer Service to support the product in the field, manage the analysis of products returned from the field, and implement product improvements.</li>
<li>Work closely with cross-functional teams, surgeons and other customers to deliver solutions to defined unmet needs.</li>
</ul>
 
You need:
<ul>
<li>Proficiency in CAD working on complex designs and creation of associated drawings / GD&amp;T.</li>
<li>Excellent attention to detail, producing high quality output.</li>
<li>Ability to work as a collaborative team member as well as independently.</li>
<li>Apply sound judgment when making decisions and communicating with peers and management.</li>
<li>Identify and resolve problems utilizing sound engineering principles and concepts.</li>
<li>Knowledge of FDA, ISO, GMP and design controls.</li>
<li>Ability to develop and execute verification, validation, and qualification protocols.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Flexibility and strong organizational skills with ability to prioritize multiple tasks.</li>
<li>Proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).</li>
<li>Experience in orthopedic devices and instruments a plus.</li>
<li>Cadaver Lab experience a plus.</li>
<li>BS/BA degree in Mechanical / Biomedical Engineering and 8 years of experience with at least 5 years in direct medical device development OR 20 years of relevant experience.</li>
</ul>
 
 We offer:
<ul>
<li>Competitive compensation including bonus and equity </li>
<li>Opportunities for career advancement</li>
<li>Full benefits package </li>
<li>An evolving, engaging culture and workplace</li>
<li>Nominated by our employees as a Top Place to Work in Orange County!</li>
</ul>
 
It is an exciting time at OrthAlign - make your next career move with us!
 
Please note that we are unable to provide any type of sponsorship at this time.
No recruiters, please.

Sr. Product Development Engineer

<h3>Job Description</h3>
Job DescriptionSalary: 
Company Description
 
Founded in 2000 locally owned and operated, RbM Services is a growing turn-key design, manufacture, and service solution provider for medical devices in Tennessees Technology Corridor. With over 100 years of combined experience in the medical device industry, our management staff has extensive experience in intellectual property development, contract design, product development, field service support, and product support of medical devices and laboratory instrumentation. Our team is passionate and even obsessed with providing solutions that deliver cutting-edge technology that improves patient experiences and outcomes. Our passion lies in the pursuit of perfection. We value our employee family and foster opportunities to engage in meaningful connections and reward employees who exceed expectations.
 
Job Description
Are you passionate about the Bio-Medical and device industry? We have an exciting opportunity for you! As part of our team, youll receive on-the-job training to excel in this field. This position involves approximately 50% travel across the United States, allowing you to explore new places while making a difference. Plus, youll retain travel perks like airline miles and hotel points for personal use.
 
<ol>
<li>Self-starter you will use independent judgment.</li>
<li>Youll be on the move with 50% travel, covering various locations within the continental United States.</li>
<li>Maintain accurate service, expense reports, and datasheets, ensuring compliance with guidelines.</li>
<li>Familiarize yourself with company quality manuals, safety procedures, and manufacturing regulations.</li>
<li>Interact professionally with customers through on-site visits and telephone calls.</li>
<li>Work on component and device assembly and repair.</li>
<li>Install and test medical equipment to ensure optimal functionality.</li>
<li>Implement measures to keep equipment in top shape.</li>
<li>Troubleshoot and address device performance issues promptly.</li>
<li>Be ready to tackle equipment malfunctions and resolve issues when needed.</li>
</ol>
 
Required Qualifications
<ul>
<li>Associate degree in electrical engineering technology with coursework in digital and analog circuits.</li>
<li>Solid grasp of electronic and engineering principles, ability to troubleshoot using schematics, DVM, and oscilloscope.</li>
<li>Mechanical skills in an assembly/disassembly environment and knowledge of various soldering techniques.</li>
<li>Must be a team player and collaborate effectively with colleagues.</li>
<li>Familiarity with computer skills, including Microsoft Word and Excel.</li>
<li>Excellent written and verbal skills.</li>
<li>Prioritize quality and safety.</li>
<li>Ability to obtain a credit card.</li>
<li>A valid drivers license.</li>
<li>Ability to manage time effectively. </li>
</ul>
 
Preferred Qualification
<ul>
<li>Understanding of biomedical devices and electronics.</li>
<li>Engineering Degree.</li>
<li>Field Experience.</li>
</ul>
 
Additional Information
<ul>
<li>As a full-time team employee, you are eligible for all RbM Services benefits, including medical, dental, vision, long-term, short-term disability, 401k, PTO, 10 paid holidays, etc.</li>
<li>All your information will be kept confidential according to the EEO guidelines</li>
</ul>

Field Service Engineer/Technician

<h3>Job Description</h3>
Job Description
Imaging Service Engineer 2 - Philadelphia
Philadelphia, PA
Under supervision this person will inspect, repair, maintain, and calibrate basic diagnostic imaging equipment, devices, systems, and instruments. Interact on a routine basis with other clinical health providers in the identification of technology-based problems. Participate in on-the-job training programs regarding technical, administrative, and customer service requirements.
The ISE II for this role will possess:
<ul>
<li>Experience in a hospital or healthcare setting</li>
<li>Have 5+ years of imaging experience</li>
<li>Ability to make decisions regarding troubleshooting and repairing medical imaging devices</li>
<li>Excellent communication, customer service and time management skills</li>
<li>Cathlab, CArms, and Ultrasound service experience (Strongly Preferred)</li>
</ul>
Position Summary:
Inspect, troubleshoot, repair, maintain, and calibrate a broad range of basic diagnostic imaging and/or therapeutic radiation equipment, devices, system, and instruments. Interact on a routine basis with other clinical health providers in the identification of technology-based problems and solution development.
Key Duties
<ul>
<li>Inspect, maintain, repair and calibrate equipment and systems</li>
<li>Ensures regulatory compliance</li>
<li>Provides advanced support of equipment for direct patient care</li>
<li>Interacts on a routine basis with clinical health providers in the identification of technology based problems and solutions</li>
<li>Solves organization-level customer service issues and complaints</li>
<li>Preparing required documentation and reports</li>
<li>Demonstrates a safety mindset</li>
<li>Financial responsibility for purchasing parts and service</li>
<li>Develops staff by teaching and mentoring others</li>
</ul>
Minimum Qualifications &amp; Requirements:
<ul>
<li>Minimum Education Requirement - Associate's Degree (or equivalent experience) in electronic, biomedical engineering or a discipline geared toward managing maintaining and repairing clinical equipment within a healthcare environment</li>
<li>Minimum Functional Experience - 5 years of imaging equipment repair and maintenance within a healthcare environment and/or entry level of formalized training and/or equivalent military training</li>
</ul>
Required Knowledge, Skills, and Abilities: (Companies ATS Questions):
1. Do you have a Associate's degree (or equivalent experience) in electronic, biomedical engineering or a discipline geared toward managing maintaining and repairing clinical equipment within a healthcare environment
2. Do you have 5 years of imaging equipment repair and maintenance within a healthcare environment and/or entry level of formalized training and/or equivalent military training
3. Do you have 5 years of imaging experience.
4. Do you have Experience in a hospital or healthcare setting.
5. Do you have Experience in troubleshooting and repairing medical imaging devices.
6. Do you have ECathlab, CArms, and Ultrasound service experience.
7. Must be a US Citizen or Green Card holder

Imaging Service Engineer 2 - Philadelphia

<h3>Job Description</h3>
Job Description
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary: 
The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving Calyxo's instruments and accessories from concept to launch and beyond We are looking for a Senior R&amp;D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, working closely alongside the systems, vision and sensors, and software R&amp;D teams, to catalyze the advancement of an innovative, single-use kidney stone treatment devices. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to integrate and implement these solutions into our commercialized product(s).
In This Role, You Will:
<ul>
<li>Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and/or external feedback.</li>
<li>Lead design-related root cause analysis efforts, and drive corrective and preventive actions.</li>
<li>Serve as an R&amp;D SME for projects lead by cross-functions, and partner with cross-functional teams to gain alignment on qualification strategies.</li>
<li>Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.</li>
<li>Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field.</li>
<li>Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.</li>
<li>Use SolidWorks to create well-defined models, assemblies, and engineering drawings.</li>
<li>Support the generation of new or revised product requirements and engineering specifications.</li>
<li>Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed.</li>
<li>Effectively communicate project progress, results, and risks to relevant stakeholders.</li>
<li>Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines.</li>
</ul>
Who You Will Report To:
<ul>
<li>Sr. Vice President, Research &amp; Development</li>
</ul>
Requirements:
<ul>
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field</li>
<li>5+ years of medical device experience (4+ with an advanced degree).</li>
<li>Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.</li>
<li>Ability to apply DFX principles to create designs that can scale.</li>
<li>Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&amp;T.</li>
<li>Track record of taking design concepts from prototyping stage through to design maturation.</li>
<li>Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.</li>
<li>Experience creating and running simulations (CFD, FEA) to inform product development.</li>
<li>Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.</li>
<li>Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.</li>
<li>Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.</li>
<li>Compliance with relevant county, state, and Federal rules regarding vaccinations.</li>
</ul>
What We Offer:
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 
We also offer an attractive compensation package, which includes:
<ul>
<li>A competitive base salary and variable incentive plan</li>
<li>Stock options – ownership and a stake in growing a mission-driven company</li>
<li>Employee benefits package that includes 401(k), healthcare insurance and paid vacation</li>
</ul>
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. 
Disclaimer:
At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:
<ul>
<li>Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.</li>
<li>Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.</li>
<li>Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of <a href="mailto:firstname.lastname@calyxoinc.com" target="_blank">firstname.lastname@calyxoinc.com</a>. If you receive a request for information from any other domain, please contact us directly at <a href="mailto:info@calyxoinc.comto" target="_blank">info@calyxoinc.comto</a> verify the legitimacy of the communication.</li>
</ul>
We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.

Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA

<h3>Job Description</h3>
Job Description
Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices.&nbsp;Join us in our mission to revolutionize structural heart solutions.
The&nbsp;Sr PD Engineer&nbsp;will be a key member of the manufacturing development and support team partnering with management, Quality Assurance, R&amp;D / Product Development, and Production functions. This is a multi-faceted role with the Engineer responsible for assisting in several critical areas including:
<ul>
<li>Test method development and validation</li>
<li>Process and product characterization</li>
<li>Equipment validation &amp; calibration set-up and requirements</li>
<li>Conducting feasibility studies and pilot programs for new process technologies.</li>
<li>Identifying and implementing new technologies and methodologies to improve existing processes</li>
</ul>
The person shall execute duties to meet cGMP requirements on time and to the highest quality standards to ensure that programs are compliant with regulatory requirements and related site SOPs. This role will have a heavy emphasis on biological tissue, production, performance, and characterization.
Primary Duties and Responsibilities
1. Process Development and Optimization:
<ul>
<li>Develop and optimize manufacturing processes for Class III medical devices, focusing on performance, quality, and efficiency.</li>
<li>Implement and oversee the validation of IMV (Installation, Operational, Performance Qualification), TMV (Test Method Validation), IQ (Installation Qualification), OQ (Operational Qualification), and PPQ (Process Performance Qualification) activities.</li>
<li>Drive continuous improvement initiatives to enhance product quality, reduce manufacturing costs, and increase productivity.</li>
<li>Comfortable performing root cause analysis using standard industry techniques (5 Whys, Fishbone, etc).</li>
<li>Lead risk management activities in compliance with ISO 14971 and FDA 21 CFR Part 820, ensuring comprehensive hazard analysis, failure mode assessments, and risk mitigation throughout the product lifecycle</li>
<li>Collaborate with cross-functional teams, including R&amp;D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.</li>
</ul>
2. Jig Fixture Automation:
<ul>
<li>Design and develop automation solutions for jig fixtures to streamline manufacturing processes and reduce manual intervention.</li>
<li>Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.</li>
</ul>
3. Validation and Documentation:
<ul>
<li>Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.</li>
<li>Create and maintain comprehensive documentation, such as work instructions, standard operating procedures (SOPs), and process flowcharts, in accordance with regulatory guidelines and Good Manufacturing Practices (GMP).</li>
</ul>
4. GMP Compliance:
<ul>
<li>Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.</li>
<li>Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.</li>
<li>Strong track record of maintaining compliance with global regulatory standards including ISO 13485</li>
</ul>
5. Cross-Functional Collaboration:
<ul>
<li>Work closely with the R&amp;D team to provide manufacturing inputs during product development, ensuring manufacturability and scalability of new designs.</li>
<li>Collaborate with the Manufacturing team to transfer new processes into production and provide ongoing support for process-related issues.</li>
<li>Lead cross-functional discussions and engage with external manufacturers or test facilities to expand team/company technologies.</li>
</ul>
 &nbsp;
Skills, Knowledge, Experience &amp; Qualifications
 &nbsp;
<ul>
<li>Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical) or related scientific field.&nbsp; Graduate degree a plus.</li>
<li>Minimum of 5 - 8 years’ experience in Process Development and Manufacturing Engineering within the medical device industry, preferably with Class III medical devices.</li>
<li>Experience completing cleaning validations is highly beneficial, particularly experience developing protocols, executing studies, and interpreting results.</li>
<li>Comfortable with performing protocol drafting, execution, data analysis, and report generation with minimal oversite.</li>
<li>Capable of working independently on validation activities including protocol drafting, execution, data analysis, and report generation with minimal oversite.</li>
<li>Specific experience with tissue-integrated Transcatheter Aortic Valve Replacement (TAVR) or Transcatheter Mitral Valve Repair (TMVR) devices is highly desirable.</li>
<li>Work experience on manufacturing processes utilizing biological materials for integration into combination products is beneficial</li>
<li>Strong knowledge and experience in validation processes (IMV-TMV-IQ-OQ-PPQ) and documentation practices in a regulated environment.</li>
<li>Familiarity with jig fixture automation and process automation techniques.</li>
<li>Understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.</li>
<li>Excellent problem-solving skills and the ability to apply engineering principles to improve processes and solve technical challenges.</li>
<li>Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.</li>
</ul>
What We Offer:
<ul>
<li>Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.</li>
<li>Collaborative and dynamic work environment with a culture of innovation and excellence.</li>
<li>Competitive compensation package, including salary, performance-based bonuses, and stock options.</li>
<li>Career development opportunities and a chance to be part of a growing company that values its employees.</li>
</ul>
Health and Wellness Offerings:
<ul>
<li>Medical, Dental, and Vision Plans</li>
<li>Flexible Spending Account (FSA)</li>
<li>401k + Company Match</li>
<li>Life, AD&amp;D, Short Term and Long-Term Disability Insurance</li>
<li>Bonus Plan Eligibility</li>
<li>Employee Stock Option Plan</li>
<li>Paid Holidays &amp; Vacation</li>
<li>Employee Assistance Program</li>
<li>Inclusive Team Environment</li>
</ul>
Note:&nbsp;We may require proof of COVID-19 vaccination to comply with the state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.&nbsp;

Senior Process Development Engineer

<h3>Job Description</h3>
Job DescriptionA growing medical device manufacturing client in Maple Grove, Minnesota is looking to hire a hands-on Engineering Manager! This will be playing a critical role in leading a dynamic team of engineers to design, develop, and innovate cardiovascular devices with a focus on heart valve technologies. This position requires a deep understanding of both the engineering principles and the medical aspects related to heart valve systems. We are looking for someone who has proven success driving product development, ensuring regulatory compliance, and fostering a culture of continuous improvement while leading by example. We are looking for someone who can not only work closely with marketing teams to understand customer needs and market trends, contributing to the development of product strategies but collaborate with Manufacturing teams to ensure seamless technology transfer and production scale-up.Duties of Role:
<ul>
<li>Oversee the entire product development lifecycle for heart valves, from concept to commercialization.</li>
<li>Collaborate with cross-functional teams, including R&amp;D, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure alignment with project goals and timelines.</li>
<li>Drive the development of novel heart valve technologies, considering both technical feasibility and clinical requirements.</li>
<li>Lead or mentor a multidisciplinary team of engineers, including mechanical and biomedical engineers.</li>
<li>Provide technical leadership and guidance to the engineering team, participating in design reviews and troubleshooting technical challenges.</li>
<li>Work closely with the Regulatory Affairs team to ensure all heart valve designs and developments comply with applicable regulatory standards and requirements.</li>
<li>Collaborate in the preparation of regulatory submissions</li>
<li>Collaborate with the Quality Assurance team to establish and maintain robust quality control processes for heart valve manufacturing.</li>
<li>Implement and oversee testing protocols to validate the performance and safety of heart valve products.</li>
</ul>
Must Haves:
<ol>
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (Master's or Ph.D.) preferred.</li>
</ol>
<ul>
<li>10 + years of experience in in medical device product development, with a focus on heart valves or cardiovascular devices.</li>
<li>Strong leadership skills and experience managing cross-functional engineering teams.</li>
<li>In-depth knowledge of relevant regulatory standards (FDA, ISO, etc.) and experience with regulatory submissions.</li>
<li>Excellent communication skills with the ability to interact effectively with internal teams, external partners, and regulatory authorities.</li>
</ul>
Salary of $120,000 to $160,000 + bonus

Engineering Manager/Principal Engineer

<h3>Job Description</h3>
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>
We are seeking a highly motivated Project Engineer with proven experience in risk management within the pharmaceutical or medical device industry. This role will be responsible for leading and supporting cross-functional projects that ensure product and process compliance while minimizing risks throughout the product lifecycle. Candidates with experience or familiarity in Turbo AC (Air Conditioning or Turbo Compressor) systems are highly desired.
Project Engineer – Risk Management (Pharma/Med Device) Responsibilities:
<ul>
<li>Lead and support risk management activities (e.g., FMEA, Fault Tree Analysis, Risk Registers) throughout the product lifecycle</li>
<li>
Coordinate with cross-functional teams (QA, Regulatory, Manufacturing, R&amp;D) to ensure risk mitigation strategies are effectively implemented
</li>
<li>
Drive the development, execution, and documentation of engineering project plans, timelines, and deliverables
</li>
<li>
Analyze and interpret engineering specifications, user needs, and technical drawings to support risk assessments and product safety evaluations
</li>
<li>
Manage technical issues and provide solutions that align with project objectives and compliance standards
</li>
<li>
Prepare and deliver clear project updates, risk reports, and design documentation to stakeholders
</li>
<li>
Support product verification and validation (V&amp;V) efforts, ensuring alignment with regulatory and industry standards
</li>
<li>
Contribute technical expertise, especially where Turbo AC systems are applicable in the design or manufacturing environment
</li>
</ul>
Requirements:
<ul>
<li>
Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field)
</li>
<li>
Minimum 3–5 years of experience in risk management within the pharmaceutical or medical device industry
</li>
<li>
Deep understanding of relevant FDA/EMA regulations
</li>
<li>
Strong project engineering and cross-functional collaboration skills
</li>
<li>
Excellent problem-solving and analytical skills
</li>
<li>
Experience or working knowledge of Turbo AC systems / or QMSpace
</li>
<li>Local resource (Indianapolis) is desired but remote is possibility for a candidate that is a solid fit</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$80,465—$132,593 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. 
For more information about our company, please visit us at Verista.com

5868 - Project Engineer / Risk Management (Pharma/Med Device)

<h3>Job Description</h3>
Job Description
Position Summary: The Kenjya-Trusant Group is looking for a System Engineer to support our Maryland Customer for cross domain solutions. Essential Job Functions: 
<ul>
<li>Applies systems engineering principles throughout the systems life cycle phases: Concept, Development, Production, Utilization, Support, and Retirement. Interacts with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts.</li>
<li>Communicates with other program personnel, government overseers, and senior executives. Responsibility for the technical integrity, quality, and completeness of work performed and deliverables associated with one or more of the 25 process areas defined by ISO/IEC15288.</li>
<ul>
<li>Technical Process Area - Stakeholder Requirements Definition, Requirements Analysis, Architectural Design, Implementation, Integration, Verification, Transition, Validation, Operation, Maintenance, and Disposal.</li>
<li>Project Process Area - Project Planning, Project Assessment and Control, Decision Management, Risk Management, Configuration Management, Information Management, and Measurement.</li>
<li>Enterprise (Organizational Project-Enabling) Process Area -Project Portfolio Management, Infrastructure Management, Lifecycle Model Management, Human Resource Management, and Quality Management.</li>
<li>Agreement Process Area - Acquisition and Supply.</li>
</ul>
<li>Assist in developing a new or innovative approach to a technical or engineering issue.</li>
<li>Assist in conducting an evaluation to determine its suitability for project implementation.</li>
<li>Supervise or coordinate the work of other contractor engineers or technicians on a project.</li>
</ul>
Minimum Required Qualifications:
<ul>
<li>Due to the nature of this position and the information employees will be able to access; US Citizenship is required.</li>
<li>Required Security Clearance: TS/SCI w/ Poly.</li>
</ul>
Level 4:
<ul>
<li>High School Diploma or GED with 14 years of general systems engineering experience. </li>
<li>Bachelor's Degree in Qualified Engineering Field or related discipline with 10 years of system engineering experience.</li>
<li>Master's degree in a Qualified Engineering Field or related discipline with 8 years of systems engineering experience.</li>
<li>PhD in a Qualified Engineering Field or related discipline with 8 years of systems engineering experience.</li>
</ul>
Level 5:
<ul>
<li>High School Diploma or GED with 19 years of general systems engineering experience. </li>
<li>Bachelor's Degree in Qualified Engineering Field or related discipline with 15 years of system engineering experience.</li>
<li>Master's degree in a Qualified Engineering Field or related discipline with 13 years of systems engineering experience.</li>
<li>PhD in a Qualified Engineering Field or related discipline with 13 years of systems engineering experience.</li>
</ul>
Level 6:
<ul>
<li>High School Diploma or GED with 24 years of general systems engineering experience. </li>
<li>Bachelor's Degree in Qualified Engineering Field or related discipline with 20 years of system engineering experience.</li>
<li>Master's degree in a Qualified Engineering Field or related discipline with 18 years of systems engineering experience.</li>
<li>PhD in a Qualified Engineering Field or related discipline with 18 years of systems engineering experience.</li>
</ul>
Qualified engineering fields include: Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, and Engineering Management.
Related disciplines include: Chemistry, Computer Science, Information Systems, Mathematics, and Physics.
Desired/Preferred Skills:
<ul>
<li>Testing and Linux Systems administration experience is a plus.</li>
</ul>
Pay Range: There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. The proposed salary range for this position is:
Level 4: $135,000 - $265,000
Level 5: $140,000 - $275,000
Level 6: $150,000 - $295,000
Employment Type: Full-time, Exempt THE KENJYA-TRUSANT GROUP, LLC is a Service-Disabled Veteran-Owned Small Business that was established in 2015 as a merger between The Kenjya Group, Inc. and Trusant Technologies, LLC. Our mission is to implement, support and protect the nation's advanced technology systems, business processes and high-technology facilities. Working with the Department of Defense, Department of Homeland Security, the Intelligence Community, state and local governments, and commercial clients, Kenjya-Trusant provides cyber protection, information technology, engineering, construction management and acquisition support services. THE KENJYA-TRUSANT GROUP, LLC is an Equal Opportunity/Affirmative Action Employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other basis prohibited by applicable law. We strive to create a diverse, inclusive and respectful work culture that values all.

System Engineer Level 4-6 (SF)

<h3>Job Description</h3>
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>
Responsibilities:
Entry level CQV Engineer position in the Pharma industry. Client will train the resource on Deviation Investigation.
Requirements
<ul>
<li>Deviation investigation remediation experience is a plus but is not necessary</li>
<li>Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.)</li>
<li>0-3 years' experience</li>
<li>Salary dependent on experience</li>
<li>Some Pharma experience preferred but not absolutely required</li>
<li>New college grads with internship experience encouraged to apply</li>
<li>Proficiency using PC and Microsoft Office tools</li>
<li>Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms</li>
<li>Ability to work as part of a team</li>
<li>Strong problem-solving and critical thinking skills</li>
<li>Excellent organizational and time management skills</li>
<li>Strong attention to detail</li>
<li>Strong interpersonal skills and clear communication capabilities</li>
<li>Experience with and tolerance for high levels of challenge and change</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$59,951—$90,878 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. 
For more information about our company, please visit us at Verista.com

5507- Deviation Investigator / Validation Engineer

<h3>Job Description</h3>
Job Description
Empower, Innovate, Impact! At Team A-TEK, we EMPOWER people to drive INNOVATION that IMPACTS mission!
A-TEK operates at the intersection of mission and innovation by applying our deep domain expertise across the federal markets. Embracing our digital-first strategy, A-TEK provides enhanced capabilities in application development, digital transformation, enterprise IT, and scientific services. Our solutions are designed to modernize, automate, secure, protect, and enhance the operations of our federal clients, ensuring they stay ahead in a rapidly evolving digital landscape.
Our work is fueled by a passion to serve our clients' needs and to protect the safety and welfare of Americans. That passion shapes how we nurture our most valuable asset – Our Employees. A-TEK actively cultivates the talent that drives our success and fosters a creative, challenging, and mission-driven work environment for current and future employees.
A-TEK, Inc., along with its wholly owned subsidiary, Mackson Consulting, is a leading provider of mission-critical IT services and digital modernization solutions to federal agencies. At the forefront of innovation, A-TEK and Mackson specialize in secure, scalable, and reliable technology implementations that advance the missions of federal health, civilian, and homeland security organizations. Our diverse portfolio includes partnerships with agencies such as NIH, FDA, CMS, DHS, DOJ, USDA, and FDIC.
We are currently seeking a HashiCorp Vault Application Engineer/Administrator to support one of our federal clients—the National Center for Biotechnology Information (NCBI) at the National Institutes of Health (NIH). In this key role, you will be instrumental in designing, deploying, and administering secure secret management systems using HashiCorp Vault across hybrid environments including on-premises and multi-cloud (AWS, GCP). This full-time role is based on site in Bethesda, MD, with flexibility for remote work.
As part of a high-impact team, you will help advance the biomedical research infrastructure that serves over six million daily users, accelerating discoveries that impact global public health. This role is ideal for professionals who are passionate about security engineering, zero trust architecture, and building resilient systems that matter.
Responsibilities:
<ul>
<li>Design, deploy, and manage HashiCorp Vault for secret management, encryption, and access control in a zero-trust environment.</li>
<li>Build and maintain secure, scalable Vault clusters, including Primary, DR, and Performance Replica deployments.</li>
<li>Integrate Vault with Kubernetes for dynamic secrets, authentication, and workload identity management.</li>
<li>Collaborate with DevOps and security teams to apply Zero Trust security models and best practices.</li>
<li>Automate Vault administration and Kubernetes orchestration through scripting and tooling.</li>
<li>Monitor Vault system health and security and optimize performance in production.</li>
<li>Ensure compliance with FISMA and other federal data protection standards.</li>
<li>Support CI/CD pipeline security through Vault integration.</li>
<li>Maintain thorough documentation of processes, architecture, and configurations.</li>
</ul>
Qualifications:
<ul>
<li>3+ years of experience as a Web Application Engineer, DevOps Engineer, or similar role.</li>
<li>Proven experience managing HashiCorp Vault in production environments.</li>
<li>Expertise in Zero Trust security concepts and cloud-native implementation.</li>
<li>Strong scripting skills in Python, Bash, or similar languages.</li>
<li>Proficiency with infrastructure-as-code tools such as Terraform, Ansible, or Puppet.</li>
<li>Experience with CI/CD platforms like GitLab CI, ArgoCD, or TeamCity.</li>
<li>Knowledge of cloud ecosystems (AWS, GCP) and their Kubernetes services (EKS, GKE).</li>
<li>Excellent problem-solving abilities, especially in complex distributed environments.</li>
</ul>
Why A-TEK | Mackson? At A-TEK and Mackson Consulting, we invest in our people with a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) plan with employer contributions, generous paid leave, and tuition/conference reimbursement. You will be part of a collaborative, mission-driven team delivering high-value solutions to agencies that shape public health and safety.
The salary range for this position is $130,000 to $180,000 based on experience.
Join us and be a part of something bigger—advancing health, science, and security through technology.
A-TEK, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or status as a qualified individual with a disability, or Vietnam era or other protected Veteran status.

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