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<h3>Job Description</h3>
Job Description
About Spectrum Vascular
Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. 
Role Description:
The Quality Engineer is responsible for providing hands-on support to assure the successful transfer of acquired technology to a contract manufacturing partner on schedule. This position will monitor, maintain, and/or improve the quality and performance of the Spectrum Vascular catheter product portfolio through technical evaluations, maintenance of design history files, and quality support to address user and/or business needs. 
Key Responsibilities:
<ul>
<li> Execute activities necessary to support the vascular access business, specifically the PICC and Mid-line catheter portfolio.</li>
<li> Monitors, maintains, and/or improves the quality and performance of the portfolio through technical evaluations, design history file maintenance, and design improvement implementation to address user and/or business needs.</li>
<li> Perform technical evaluations related to supplier and manufacturing changes to existing products.</li>
<li> Perform design change assessments to determine impact of changes to commercial products.</li>
<li> Support new indications, regulations, and marketed regions associated with existing commercial products.</li>
<li> Maintain Risk Management Files for existing products based on post market surveillance.</li>
<li> Interfaces with external suppliers and internal project teams to ensure the quality of Spectrum Vascular products. </li>
<li> Review test protocols and reports to support development and transfer of projects. </li>
<li> Ensure all activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities (per 21 CFR 820.30, 21 CFR part 4, ISO 13485), and work closely with team to establish and maintain design control procedures.</li>
<li> Partner with functional areas to develop appropriate prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges.</li>
<li> Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program.</li>
<li> Effectively manage multiple projects and responsibilities.</li>
</ul>
Role Requirements:
<ul>
<li> Bachelor's degree in mechanical or biomedical engineering preferred.</li>
<li> Three years-plus of relevant medical device industry experience in quality engineering and/or manufacturing operations.</li>
<li> Knowledge and understanding of molding and extrusion operations, as well as assembly, labeling, and packaging.</li>
<li> Good understanding of FDA regulations, QMS, GMP and ISO standards.</li>
<li> Experience managing diverse project activities with contract CMO facilities, and in particular managing and communicating quality requirements between vendors.</li>
<li> Strong computer skills including proficiency in Excel, Word, SolidWorks, eQMS, and statistical methods.</li>
<li> Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results.</li>
<li> Natural entrepreneurial spirit with unrelenting dedication to delivering results.</li>
<li> Desire to work in a fast-paced, innovative environment.</li>
<li> Natural collaborator who enjoys working on a cross-functional team.</li>
</ul>
Work Environment:
<ul>
<li> Remote-based</li>
<li> Dynamic, interactive, fast-paced, and entrepreneurial environment</li>
<li> Travel – up to 35%, additional may be required during execution of validation activities</li>
</ul>
Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law. 
ime.

Quality Engineer

<h3>Job Description</h3>
Job DescriptionQuality Engineer
Status: Full-time, Exempt
Reports to: Sr. Director of R&amp;D
About the Role
VahatiCor, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer with direct catheter device experience and proven ISO 13485 expertise to support the production of groundbreaking medical devices. This is a hands-on role focused on catheter manufacturing, documentation development, process improvement, testing, and risk assessment.
Key Responsibilities
- Develop and maintain Quality System documentation including MPIs, SOPs, work instructions, test methods, protocols (DV), and validation reports. - Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and ICH guidelines. - Support combination product regulatory filings and clinical trials (US and OUS). - Assist in sterile product lot release documentation. - Participate in internal and external audits, inspections, and supplier quality assessments. - Partner with R&amp;D, engineering, and manufacturing to integrate quality standards across the product lifecycle. - Identify and help close gaps in manufacturing and documentation processes. - Support development and refinement of workflows for manufacturing and testing. - Assist in the design and implementation of fixtures, tooling, and process improvements to enhance catheter production. - Conduct root cause analysis and support CAPA implementation to resolve quality issues. - Contribute to the development and validation of test methods for catheter components and final assemblies. - Perform risk assessments (FMEA, hazard analysis) to proactively identify and mitigate quality risks. - Collaborate with R&amp;D, Manufacturing, and Regulatory teams to ensure product quality and reliability. - Verify that all product releases meet defined quality criteria before market launch.
Qualifications
- Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; or equivalent technical background. - 5+ years of Quality experience in the regulated medical device industry, with direct hands-on catheter manufacturing and testing experience. - Proven, practical expertise in ISO 13485 implementation and compliance, plus strong knowledge of FDA 21 CFR Part 820, GMP, and ISO 14971 risk management. - Experience in process optimization, test method development, equipment validation, and regulatory compliance. - Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports. - Strong organizational and communication skills, with the ability to manage multiple priorities in a dynamic environment. - Hands-on, startup mentality with a proactive approach to problem-solving and continuous improvement. - Ability to work cross-functionally to identify and close process gaps.
Eligibility
Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas.
Location &amp; Compensation
This is an onsite role based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. 
T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.
The anticipated salary range of this position is $132,000 - $178,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills. 
Equal Employment Opportunity Statement
T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. 
We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.
Third-Party Recruiter Notice
We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email <a href="mailto:careers@t45labs.com" target="_blank">careers@t45labs.com</a>.

<h3>Job Description</h3>
Job Description
 
MoFe Engineer
Are you an innovative Field Service Engineer with a passion for cutting-edge technology? Join Sightpath Medical, the premier provider of mobile cataract and LASIK services in the U.S. You’ll have the unique opportunity to work with advanced ophthalmic equipment while supporting top surgeons in a fast-paced and rewarding environment. Whether you’re an entry-level candidate or bring years of experience, we offer knowledge, collaboration, and a shared commitment to excellence.

Why Sightpath Medical?
<ul>
<li>Comprehensive Training: Gain hands-on experience with the latest in ophthalmic laser technology. We provide all the training you need to excel in the field.</li>
<li>Independent Work Environment: You’ll have the autonomy to manage your work effectively while being part of an expert team.</li>
<li>Travel: You will have ownership of an assigned territory you will manage with a company provided vehicle and equipment. Every day is different. You will move from facility to facility providing expert service to our customers.</li>
<li>Work-life balance: With 8-10 case days per month, enjoy flexibility on non-case days when working from home or while traveling.</li>
<li>Medical benefits including health, dental, vision, short/long-term disability, and health savings account.</li>
<li>401(k) plan with employer contribution.</li>
<li>Health and Wellness Program to support your well-being.</li>
</ul>

What You’ll Do:
<ul>
<li>Technical Expertise: Install, de-install, calibrate, and operate transportable lasers and related equipment at customer sites.</li>
<li>Surgical Support: Ensure all equipment is programmed and calibrated to surgeon specifications prior to surgeries. You will also support the Surgeons during surgery to ensure customer satisfaction.</li>
<li>Preventative Maintenance: Perform routine maintenance and repairs to maximize equipment performance and minimize downtime.</li>
<li>Troubleshooting: Diagnose and resolve equipment issues efficiently, ensuring seamless surgical procedures.</li>
<li>Sterile Technique and Clinical: Adhere to sterile techniques during surgeries to ensure patient safety. Comprehensive training will be provided for all clinical aspects and requirements.</li>
<li>Manual Labor: Willing and able to assist with equipment setup and transport.</li>
<li>Other Duties: Flexibility to take on additional responsibilities as required.</li>
</ul>

Who We’re Looking For:
<ul>
<li>Technical Degree: Degree in Laser Electro-optics, Biomedical Equipment Technology, Electronics, or a similar field; military training in related fields is also acceptable.</li>
<li>Hands-On Experience: Proficiency with basic electronics and test equipment. Experience with laser systems is a plus.</li>
<li>Adaptable and Travel-Ready: Comfortable with driving to various locations in assigned territory and staying overnight when needed. All travel expenses are covered (hotel stays, gas for company vehicle, and meal allowances while traveling).</li>
<li>Driving Record: Able to produce a valid driver's license and pass a Motor Vehicle Report (MVR)/ driving record.</li>
<li>Excellent Communicator: Able to build strong relationships quickly with surgeons and their teams.</li>
<li>Self-assured: Able to thrive in high-pressure environments with confidence and professionalism.</li>
<li>Organized and Detail-Oriented: Skilled at managing equipment and completing administrative tasks required to support assigned territory.</li>
</ul>
<ul>
<li>Physical Demands: Ability to lift up to 100 lbs. and stand for extended periods.</li>
</ul>
Relocation Assistance:
We offer relocation allowances for qualified candidates who may need to move to join our team.
 
SIGHTPATH is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age (40 and over), national origin or ancestry, physical or mental disability, genetic information or any other consideration protected by federal, state or local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including supervisors and coworkers.
PM25
 
Compensation details: 60000-70000 Yearly Salary
 
PI578c8a183923-25405-38327992

MoFe Engineer

<h3>Job Description</h3>
Job Description
 
See yourself as a MoFe Engineer at Sightpath Medical!!
In addition to learning the latest innovations in the ophthalmic industry, Sightpath Medical offers a challenging and rewarding environment where you'll work with smart, fun and energetic people.
 &nbsp;• Sightpath Medical is the premier cataract and LASIK mobile services provider in the U.S. &nbsp;• We provide an independent working atmosphere &nbsp;• We provide on the job training to help you become an expert in our area of expertise &nbsp;• Salary position with quarterly bonus eligibility &nbsp;• 401(k) plan &nbsp;• Medical Benefits including medical, dental, vision, health savings account, short term disability, long term disability &nbsp;• Health and Wellness Program &nbsp; &nbsp;Responsibilities: &nbsp;• Requires the ability to install/de-install and operate transportable lasers and related equipment on one business unit at&nbsp;&nbsp;&nbsp; customer sites. &nbsp;• Responsible for calibration and programming of equipment for surgeon's approval prior to surgery being performed. &nbsp;• Responsible for the operation of both lasers when they are both required. &nbsp;• Provide routine preventative maintenance and repairs on the laser systems to maximize usage and minimize downtime. &nbsp;• Ability to troubleshoot, remove and replace components of the laser and calibrate to vendor specifications. &nbsp;• Responsible for maintaining all company assets in good working order. &nbsp;• Adherence to company standard operating procedures that meet/exceed standard of care. &nbsp;• Ability to complete Annual and Semi-Annual Preventative Maintenance checks and services on all assigned equipment. Successfully completes all PM paperwork during &nbsp;and at the end of PM. &nbsp;• Understands and adheres to proper sterile technique. &nbsp;• Other duties as required &nbsp; &nbsp;Qualifications: &nbsp;• Degree in Laser Electro-optics, Biomedical Electronics, Electronics or military training equivalent. &nbsp;• Proficiency with basic electronics and associated test equipment. &nbsp;• Able to work a varied work schedule and travel. &nbsp;• Able to work in a team environment. &nbsp;• Valid Driver's License &nbsp;• Ability to pass company administered road test. &nbsp;• Ability to occasionally lift 50 lbs. &nbsp;• Ability to stand for extended periods of time. &nbsp;• Able to work a varied work schedule and travel. &nbsp;• Great customer service skills.
 
 
PM25
 
Compensation details: 65000-70000 Yearly Salary
 
PI89fc90cf7030-25405-38089402

MoFe Engineer I

<h3>Job Description</h3>
Job Description
 
See yourself as a MoFe Engineer at Sightpath Medical!!
In addition to learning the latest innovations in the ophthalmic industry, Sightpath Medical offers a challenging and rewarding environment where you'll work with smart, fun and energetic people.
 • Sightpath Medical is the premier cataract and LASIK mobile services provider in the U.S. • We provide an independent working atmosphere • We provide on the job training to help you become an expert in our area of expertise • Salary position with quarterly bonus eligibility • 401(k) plan • Medical Benefits including medical, dental, vision, health savings account, short term disability, long term disability • Health and Wellness Program Responsibilities: • Requires the ability to install/de-install and operate transportable lasers and related equipment on one business unit at customer sites. • Responsible for calibration and programming of equipment for surgeon's approval prior to surgery being performed. • Responsible for the operation of both lasers when they are both required. • Provide routine preventative maintenance and repairs on the laser systems to maximize usage and minimize downtime. • Ability to troubleshoot, remove and replace components of the laser and calibrate to vendor specifications. • Responsible for maintaining all company assets in good working order. • Adherence to company standard operating procedures that meet/exceed standard of care. • Ability to complete Annual and Semi-Annual Preventative Maintenance checks and services on all assigned equipment. Successfully completes all PM paperwork during and at the end of PM. • Understands and adheres to proper sterile technique. • Other duties as required Qualifications: • Degree in Laser Electro-optics, Biomedical Electronics, Electronics or military training equivalent. • Proficiency with basic electronics and associated test equipment. • Able to work a varied work schedule and travel. • Able to work in a team environment. • Valid Driver's License • Ability to pass company administered road test. • Ability to occasionally lift 50 lbs. • Ability to stand for extended periods of time. • Able to work a varied work schedule and travel. • Great customer service skills.
 
 
PM25

<h3>Job Description</h3>
Job Description
Ready to simulate success? Join our innovative team!
Are you a problem-solver who thrives on tackling complex engineering challenges? Do you geek out over the power of simulation tools like Ansys to bring ideas to life? If so, we want you to be part of our cutting-edge team!
At OsteoCentric Technologies, we’re redefining what’s possible. As a Simulation Engineer, you’ll have the opportunity to shape the future, working on groundbreaking projects that make a real impact. With access to state-of-the-art tools, a collaborative team of experts, and an environment that values innovation, this is your chance to flex your technical muscles and take your career to the next level.
The Simulation Engineer is responsible for performing advanced simulation and analysis using Ansys software (Mechanical, Motion, LS-DYNA, or optiSLang) to support product design and development. They will perform complex simulations, analyze results, and offer optimization recommendations for OsteoCentric products in the Medical Device and Industrial spaces. This role requires a proactive, collaborative engineer with experience in finite element analysis (FEA), dynamic modeling, or optimization processes, capable of working cross-functionally to drive innovation and product quality. This position is required to work in our Logan, UT office.
In this role you will:
<ul>
<li>Develop, set up, and execute simulation models using Ansys Mechanical, Ansys Motion, Ansys LS-DYNA, or Ansys optiSLang, depending on project requirements.</li>
<li>Perform finite element analysis (FEA) for structural, thermal, and/or dynamic simulations, and provide insights for design improvements.</li>
<li>Collaborate with design, R&amp;D, and product development teams to define simulation requirements and translate them into functional models.</li>
<li>Analyze and interpret simulation results, generating comprehensive reports to inform engineering and design decisions.</li>
<li>Conduct sensitivity and optimization studies using Ansys tools to ensure robustness and reliability in product design.</li>
<li>Troubleshoot and validate models to ensure accuracy and alignment with real-world testing and performance.</li>
<li>Participate in product testing and validation to correlate simulation data with physical data.</li>
<li>Stay current with advances in simulation technology and incorporate new methodologies to enhance simulation capabilities.</li>
<li>Prepare, deliver, and support technical presentations, publications, and IP filings based on the learnings from simulations, for both internal and external audiences. </li>
<li>Function as simulation Subject Matter Expert (SME), including training others on the mechanics and use of simulation tools, administrating and coordinating licenses and subscriptions, and recommending appropriate hardware. </li>
<li>Perform special projects and other duties as assigned.</li>
</ul>
Required Skills/Abilities:
<ul>
<li>Strong understanding of finite element analysis (FEA) and dynamic modeling principles.</li>
<li>Proficiency in developing, validating, and optimizing complex simulation models.</li>
<li>Familiarity with multi-physics simulation, particularly structural, thermal, and/or dynamic analyses.</li>
<li>Knowledge of scripting languages (e.g., Python) and familiarity with CAD software (e.g. SolidWorks).</li>
<li>Strong analytical, problem-solving, and decision-making abilities.</li>
<li>Excellent verbal and written communication skills, with the ability to create clear and actionable reports.</li>
<li>Collaborative team player with a proactive, self-driven work ethic.</li>
</ul>
Minimum Qualifications:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Aerospace Engineering, or Biomedical Engineering (with Mechanical concentration) from an accredited institution. Graduate degrees and certificates are preferred.</li>
<li>Minimum of 5 years of experience in engineering simulation, specifically with Ansys tools.</li>
<li>Proven expertise in at least one of the specified Ansys software systems: Ansys Mechanical, Ansys Motion, Ansys LS-DYNA, or Ansys optiSLang. Ansys certification/credentials preferred.</li>
</ul>
About Us:
UnifiMI Industrial was founded in 2024 and is a wholly-owned subsidiary of OsteoCentric Technologies. OsteoCentric was founded in 2015 to design, develop and innovate new advanced medical device technologies. Our flagship UnifiMI technologies have revolutionized the implant to bone interface utilizing both patented minimally invasive bone preparation technology and unique next-generation thread geometries. Our goal is to leverage MIS technology to significantly improve and accelerate a patient’s path to recovery. Our two state-of-the-art global innovation headquarters are located in Austin, Texas and Logan, Utah.
Fun facts about us:
<ul>
<li>70+ patents globally</li>
<li>100,000+ surgical implants used</li>
<li>Devices in 90+ level one trauma centers</li>
<li>20 FDA Clearances and counting</li>
<li>11 Commercialized Products</li>
<li>And this is just the beginning!</li>
</ul>
Compensation: Compensation will be determined based on experience and qualifications.
Benefits:
<ul>
<li>Significant employer contributions to Health, Vision, and Dental plans</li>
<li>A fully employer-sponsored life insurance plan</li>
<li>Voluntary: Additional Life/AD&amp;D Insurance, Long Term Disability, and Short-Term Disability</li>
<li>401(k) Plan</li>
<li>15 days of Paid Time Off (PTO)</li>
<li>10 Holidays + 2 Floating Holidays of your choice</li>
<li>Employee recognition and development</li>
</ul>
Disclaimers: 
<ul>
<li>We do not accept applications from third-party recruiters or staffing agencies.</li>
<li>At this time, we are unable to sponsor work visas. Applicants must have authorization to work in the United States without sponsorship.</li>
</ul>

Simulation Engineer

<h3>Job Description</h3>
Job Description
Job Title: Automation Design Engineer
Job Location: Philadelphia Job Type: [Full-Time] Reports To: [VP Engineering]
Company Overview: Biomeme is a leading innovator … We are committed to providing high-quality solutions to our customers and are seeking a talented and experienced Automation Design Engineer to join our dynamic engineering team.
Position Summary: As an Automation Design Engineer, you will be responsible for designing, developing, and optimizing production line fixtures for the manufacturing of biotech instruments. You will work closely with cross-functional teams to ensure that fixtures are reliable, efficient, and meet the high standards required for precision manufacturing in the biotech industry.
Key Responsibilities:
<ul>
<li>Design and develop innovative fixtures through software and hands-on work for automation production lines, ensuring alignment with product specifications, regulatory standards, and manufacturing requirements.</li>
<li>Collaborate with manufacturing, mechanical, and electrical engineering teams to integrate fixtures seamlessly into automated production lines.</li>
<li>Conduct feasibility studies and simulations to validate fixture design and optimize for cost, efficiency, and scalability.</li>
<li>Review and refine designs using CAD software (e.g., SolidWorks) and ensure designs are manufacturable, functional, and robust.</li>
<li>Develop detailed technical drawings and specifications for fixture manufacturing, ensuring they comply with quality and regulatory standards.</li>
<li>Work closely with the production team to troubleshoot and resolve any fixture-related issues that arise during the production process.</li>
<li>Implement continuous improvements to production line fixtures, ensuring minimal downtime and increased throughput in a fast-paced environment.</li>
<li>Support testing and validation of fixtures to ensure performance under real-world conditions, ensuring they meet the stringent requirements for biotech instrument production.</li>
<li>Provide technical support to manufacturing teams to ensure proper fixture use, maintenance, and troubleshooting.</li>
<li>Stay up-to-date with the latest trends and technologies in fixture design, automation, and biotech instrument manufacturing.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.</li>
<li>Proven experience (3+ years) in fixture design and automation for high-precision manufacturing, preferably within the biotech, medical device, or automation industries.</li>
<li>Strong proficiency in CAD software (SolidWorks, AutoCAD, or similar).</li>
<li>Knowledge of manufacturing processes and material selection, particularly in automated production environments.</li>
<li>Familiarity with regulatory standards and quality control processes in the biotech or medical device industries (e.g., ISO 13485, GMP).</li>
<li>Strong problem-solving skills with a focus on continuous improvement and innovation.</li>
<li>Excellent communication and teamwork skills to collaborate effectively with cross-functional teams.</li>
<li>Detail-oriented with a strong commitment to quality, safety, and operational efficiency.</li>
<li>Ability to work independently and manage multiple projects simultaneously.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Experience with the design and integration of automated systems for biotech instrument production.</li>
<li>Familiarity with PLCs, robotics, and control systems used in automated production lines.</li>
<li>Experience in prototyping, testing, and validating mechanical components in a production environment.</li>
</ul>
Benefits:
<ul>
<li>Competitive salary and benefits package.</li>
<li>Opportunities for career growth and professional development.</li>
<li>Health, dental, and vision insurance.</li>
<li>Retirement savings plan with company contributions.</li>
<li>Collaborative and innovative work environment.</li>
</ul>
If you are passionate about precision engineering, automation, and contributing to the development of life-changing biotech instruments, we encourage you to apply.
How to Apply: Please submit your resume, portfolio (if applicable), and a cover letter detailing your experience and qualifications through applying on our website, biomeme.com.

Automation Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
 The Process Engineer II is responsible for ensuring the organization is compliant with all applicable regulations and standards in the areas of process validations. In addition, this position leads process change and improvement throughout the different areas of the company, including manufacturing. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to the manufacturing floor. The Process Engineer II makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
Requirements:
Duties and responsibilities
<ul>
<li>Provide backup support to the Director Research and Development Operations, as needed.</li>
<li>Perform critical review of Process Engineer I project plans and related documents to ensure implementation is accurate and timely.</li>
<li>Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against plan.</li>
<li>Perform data and technical presentation reviews as needed.</li>
<li>Understand and apply the applicable regulations and standards for equipment qualification and process validation to ensure compliance.</li>
<li>Statistical and analytical methods to understand processes.</li>
<li>Use LEAN Manufacturing principles to analyze and make recommendations for process optimization and implementation.</li>
<li>Work with other department heads or designees on projects as delineated on project plans to ensure timely completion of projects.</li>
<li>Develop equipment and process validation protocols (IQ, OQ, PQ) and reports as needed.</li>
<li>Lead and perform equipment qualifications and process validations as needed. </li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Develop and implement solutions with minimal supervision.</li>
<li>Comply with FDA and AATB tissue banking standards. </li>
<li>Other duties as assigned.</li>
</ul>
Qualifications
<ul>
<li>BS in Biomedical, Mechanical, Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>A minimum of 3 years of experience in Tissue Banking, Device, Biologics, or pharmaceutical industry in a relevant engineering role. Leadership experience preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred. </li>
<li>Strong knowledge of 21CFR 1271 regulations and AATB guidelines.</li>
<li>Highly proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment). </li>
<li>Strong work ethics. </li>
</ul>
Working conditions
Job requires working in office. Must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing.
 
Physical requirements
Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
Intern
 
Nothing in this job description restricts management’s right to assign or reassign duties and 
responsibilities to this job any time. 
Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.
Vivex Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

Process Engineer II

<h3>Job Description</h3>
Robotics Engineer and Interdisciplinary Scientist The Opportunity: To achieve an organization's mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether completing an immediate task, recognizing a process gap, recommending a solution, or flexing to support an immerging requirement, our clients need someone who can help manage operations while managing responses to external inquiries in a timely manner. That is why we need an experienced Robotics Engineer like you who can help conceptualize, create, and execute government funded research and development programs. As part of our team, you'll serve as a strategic technical advisor to the Advanced Research Projects Agency for Health ( ARPA-H ) , helping conceptualize, create, and execute advanced government-funded research and development programs to accelerate better health outcomes for everyone. You'll work with world-class scientists and engineers to support the development of high-impact solutions to society's most challenging health problems, and leverage technical expertise to provide strategic assessments of new technologies in support to senior ARPA-H decision makers. You'll maintain responsibility for producing and presenting findings and recommendations to a team of colleagues and clients on the feasibility and potential impact of future research programs, assisting with the management of current programs, and facilitating commer cia lization of successfully developed technologies. You'll support the research and development of robotic and unmanned systems across multiple operational domains and mission areas. You will be responsible for managing incoming requirements, facilitating e nga gements within offices and across the agency, and be readily available to shift your focus to fulfill emerging client requests. Your attention to detail, flexibility, communication skills, understanding of the client's mission, and problem-solving will enable the mission's success. Join us. The world can't wait. You Have: 
<ul>\n
<li>Experience interacting and communicating with senior-level executives, including SES or GS-15</li>
\n
<li>Experience using Micro sof t Office programs, including Excel, Word, and PowerPoint</li>
\n
<li>Ability to operate independently within a fast-paced, start-up environment</li>
\n
<li> Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements </li>
\n
<li>Master's degree in an EE, Mechanical Engineering, CS, Robotics, or Biomedical Engineering field and 5+ years of experience with engineering robotics or devices, or Doctorate degree in an EE, Mechanical Engineering, CS, Robotics, or Biomedical Engineering field and 2+ years of experience with engineering robotics or devices</li>
\n</ul>
\n Nice If You Have: 
<ul>\n
<li>Experience with programming languages such as Python, C++, Java, and MATLAB</li>
\n
<li>Experience with circuit design, microcontrollers, and embedded systems for robotic systems</li>
\n
<li>Experience with sensor or actuator integration and data fusion for simultaneous localization, mapping, and planning</li>
\n
<li>Experience with robotic operating systems for simulation, visualization, and communication between different components</li>
\n
<li>Experience with User- Center ed Design for customer needs-driven engineering development </li>
\n
<li>Experience supporting commer cia l innovation center s, university applied robotics center s, ARPA-like programs such as DARPA, IARPA, or APRA-E, or U.S. DoD advanced development programs</li>
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<li>Knowledge of AI and ML techniques for developing intelligent behaviors and robotic decision-making processes </li>
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<li>Possession of excellent verbal and written communication skills</li>
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\n Vetting: Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client . Compensation At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page. Salary at Booz Allen is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $99,000.00 to $225,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen's total compensation package for employees. This posting will close within 90 days from the Posting Date. Identity Statement As part of the application process, you are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud. Work Model Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely. 
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<li>If this position is listed as remote or hybrid, you'll periodically work from a Booz Allen or client site facility.</li>
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<li>If this position is listed as onsite, you'll work with colleagues and clients in person, as needed for the specific role.</li>
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\n Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.

Robotics Engineer and Interdisciplinary Scientist

<h3>Job Description</h3>
Job Description 
Location: Bethesda, MD 
Work Type: Hybrid Work (Minimum 2 Days Onsite) 
Required Clearance: Ability to obtain Public Trust 
LCG, Inc. provides insight into the impact of public programs that advance our society. For more than 20 years, LCG, Inc. has been a leading provider of technology-based consulting services, biomedical research support, grants management, decision analytics, software engineering and IT operations that enhance the transparency, efficiency, and empowerment of programs with health and science missions 
Job Title: Scientific Systems Integration Engineer 
Job Overview: The Scientific Systems Integration Engineer provides strategic and technical leadership in the design, configuration, and management of complex biomedical informatics systems, with a focus on terminology processing, semantic data integration, and ontology-based software environments. This role supports key infrastructure such as the NCI Thesaurus and Metathesaurus by ensuring the quality, scalability, and semantic integrity of information systems used across cancer research and public health informatics domains. 
Key Responsibilities 
Strategic Systems Consulting 
<ul>
<li>Serve as a senior consultant on complex IT and scientific informatics projects, advising stakeholders on system architecture, technical methodologies, and automation strategies for biomedical information processing. </li>
<li>Participate in high-level studies and analyses to support the planning, acquisition, and implementation of major system components and modifications. </li>
<li>Lead feasibility assessments, develop functional specifications, and evaluate system security and integration concerns. </li>
</ul>
MEME5 and Terminology Management 
<ul>
<li>Configure, operate, and update MEME5 software for terminology development, including managing source insertions, inversions, and UMLS updates. </li>
<li>Execute and manage the full MEME5 production cycle for the NCI Metathesaurus. </li>
<li>Run QA scripts and export to Rich Release Format (RRF), converting for NCI-specific Metathesaurus loads. </li>
</ul>
NCI Thesaurus and Semantic Infrastructure 
<ul>
<li>Support development and maintenance of the NCI Thesaurus by producing configuration scripts, evaluating software, and managing linked data and RDF-based components. </li>
<li>Work closely with software developers, DBAs, and QA specialists to support the EVS terminology server and search applications. </li>
<li>Maintain and enhance EVS semantic systems, including Triplestore databases, OWL ontologies, and SPARQL query operations. </li>
</ul>
Application Configuration and Cloud Integration 
<ul>
<li>Assist in the development and configuration of client-server Java systems and web applications used in semantic processing. </li>
<li>Collaborate with DevOps teams to ensure Elasticsearch-based EVS search engine indexing is optimized and stable in a cloud-based environment. </li>
</ul>
Communication and Documentation 
<ul>
<li>Prepare technical reports, feasibility studies, executive presentations, and system documentation. </li>
<li>Serve as a point of contact for scientific and technical inquiries, bridging domain expertise and IT implementation. </li>
</ul>
Qualifications 
<ul>
<li>Advanced degree in Computer Science, Information Systems, Engineering, Library Sciences, or a related scientific or technical discipline. </li>
<li>Minimum of ten (10) years of progressive professional experience in systems analysis, configuration, and scientific informatics. </li>
<li>Familiarity with terminology systems such as the NCI Metathesaurus and NCI Thesaurus. </li>
<li>Proficiency in description logic tools, OWL2, and RDF/linked data. </li>
<li>Experience with Triplestore technology and SPARQL. </li>
<li>Understanding of Elasticsearch configuration in a cloud-based environment. </li>
<li>Ability to coordinate across multidisciplinary teams, including software engineers, informaticians, and system administrators. </li>
<li>Demonstrated ability to lead and manage large-scale system implementation efforts. </li>
<li>Experience configuring and running MEME5 production cycles. </li>
<li>Strong scripting skills for data analysis, configuration, and automation tasks. </li>
<li>Analytical thinker with deep technical knowledge and systems-level insight. </li>
<li>Effective communicator who can translate complex technical topics into strategic decisions. </li>
<li>Detail-oriented problem-solver comfortable in high-stakes, high-visibility environments. </li>
</ul>
Compensation and Benefits 
The projected compensation range for this position is $90,000 to $130,000 per year benchmarked in the Washington, D.C. metropolitan area. Salary at LCG is determined by various factors, including but not limited to role, location, the combination of education/training, knowledge, skills, competencies, certifications, and work experience. 
LCG offers a competitive, comprehensive benefits package which includes health insurance options (medical, dental, vision), life and disability insurance, retirement plan contributions, as well as paid leave, federal holidays, professional development, and lifestyle benefits. 
Devoted to Fair and Inclusive Practices 
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. 
If you are interested in applying for employment with LCG and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department by email at <a href="mailto:hr@lcginc.com" target="_blank">hr@lcginc.com</a>. 
Securing Your Data 
Beware of fraudulent job offers using LCG's name. LCG will never request payment-related details or advancement of money during the application process. Legitimate communication will only come from lcginc.com or <a href="mailto:system@hirebridgemail.com" target="_blank">system@hirebridgemail.com</a> emails, not free commercial services like Gmail or WhatsApp. If you receive suspicious emails asking for payment or personal information, contact us immediately at <a href="mailto:hr@lcginc.com" target="_blank">hr@lcginc.com</a>. 
If you believe you are the victim of a scam, contact your local law enforcement and report the incident to the U.S. Federal Trade Commission.

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