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<h3>Job Description</h3>
Job DescriptionR&amp;D Sustaining Engineer
100% ONSITE - Westlake Village CA
(This role is not eligible for work visa sponsorship)
Caldera Medical’s Mission - To Improve the Quality of Life for Women!
 
Message from the Hiring Manager: The R&amp;D Sustaining Engineer will lead projects and provide technical expertise to ensure the ongoing reliability, compliance, and cost-effectiveness of our existing medical device products. This role is crucial for supporting products throughout their lifecycle by resolving manufacturing issues, implementing design changes, and leading continuous improvement initiatives. The engineer will collaborate with cross-functional teams, including manufacturing, quality, supply chain, and regulatory affairs, to address challenges and maintain product quality. 
Duties and Responsibilities: 
Project Leadership: Lead small to intermediate-sized sustaining engineering projects, including product and process improvements, cost reduction initiatives, and component obsolescence management.
Manufacturing Support: Act a primary R&amp;D resource for manufacturing and production issues. Work closely with the manufacturing engineering team to troubleshoot and perform root cause analysis on product and process failures and implement effective corrective and preventive actions (CAPAs).
Design and Process Changes: Coordinate and complete the following as needed for all sustaining engineering objectives:
a. Project Schedule
b. Quality and Regulatory documents
c. Labeling and IFU changes
d. Design Requirements - Trace Matrix
e. Design Specifications - Trace Matrix
f. Real Time Aging retention, testing
g. V&amp;V testing, documentation
h. Testing protocols and reports
i. Support Engineering Evaluation of returned product when needed.
j. Competitive product evaluation including standard testing
k. Support change Orders, technical review, implementation when needed
 Required Knowledge, Skills and Abilities:
Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
Experience: 4+years of experience in a regulated industry, with a strong emphasis on medical device product development or sustaining engineering. Experience with Class II or Class III medical devices is preferred. Experience in medical device component and material processing, design, and manufacturing. A comprehensive understanding of ISO, GMP and FDA regulations for the development.
Other Requirements:
1. Strong analytical and problem-solving skills and comprehensive understanding of design control processes, risk management, and validation of processes/designs.
2. Proven project management skills.
3. Experience with lean manufacturing and continuous improvement methodologies
4. Effective verbal, presentation and written communication skills.
5. Proficient in Microsoft Office, and MS project.
6. Working experience in Solidworks.
7. Working knowledge of medical device development, sterilization requirements and techniques, and medical device regulations.
8. Additional responsibilities may be assigned as needed to support business objectives.
Travel Required
<ul>
<li>10%</li>
</ul>
Competitive Compensation, Comprehensive Benefits, and more!
<ul>
<li>100k-$120k Annual Salary</li>
<li>Medical and Dental Benefits – 75% paid for employee and family members</li>
<li>Vision Coverage</li>
<li>401(k) with 4% matching contributions after 90 days of employment</li>
<li>Basic Life and AD&amp;D</li>
<li>Unlimited Vacation Policy</li>
<li>6 Weeks Paid Maternity Leave</li>
<li>10 paid holidays- including your birthday!</li>
<li>Being surrounded by amazing people!</li>
</ul>
(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)
Our Culture- Where Career and Passion come together!
<ul>
<li>A Culture of family and team… not a corporate goliath where you’re just another number.</li>
<li>All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.</li>
<li>The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.</li>
<li>Our goal is to treat 1 million women suffering from incontinence by 2027!</li>
</ul>
Who is Caldera Medical?
Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.
Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.

R&D Sustaining Engineer

<h3>Job Description</h3>
Job Description
POSITION: QUALITY ENGINEER
DESCRIPTION SUMMARY
Responsible for sustaining and improving the processes required to manufacture a medical device under the guidance of an ISO 13485 Quality Management System, FDA requirements, and other international standards. Quality Engineer will be a member of the engineering team and report to the Manufacturing Engineering Manager.

PRIMARY RESPONSIBILITIES
<ul>
<li>Lead technical resource for Quality, RMA and Technical Support.</li>
<li>Plan, execute and oversee component inspection and testing process to verify conformance with specifications.</li>
<li>Create and revise incoming inspection documentation.</li>
<li>Work collaboratively with Quality team members to manage the NCR process including documentation, supplier communication, product returns and rework, SCAR root cause investigations and issue resolution.</li>
<li>Initiate and rationalize engineering changes from nonconforming component issues, suggest changes for approval or rejection.</li>
<li>Develop design recommendations to improve product reliability and performance.</li>
<li>Develop, test, and implement design changes as well as coordinate with suppliers and manufacturers to ensure smooth implementation.</li>
<li>Provide technical resource regarding equivalency in value engineering and analysis for current components and future product development projects.</li>
<li>Manage Bill of Materials across multiple product lines.</li>
<li>Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.</li>
</ul>
KNOWLEDGE AND SKILL REQUIREMENTS 
<ul>
<li>5+ years of experience in a manufacturing environment required.</li>
<li>Bachelor’s degree in Engineering (Mechanical, Manufacturing or Biomedical) required.</li>
<li>Working knowledge of AS 9100, ISO 9001 and/or ISO 13485 preferred</li>
<li>Proficient In CAD with SolidWorks expertise preferred.</li>
<li>Knowledge of manufacturing operations, process verification and validation, geometric dimensioning and tolerancing (GD&amp;T) including the ability to create and understand prints and specifications.</li>
<li>Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.</li>
<li>Mechanically inclined with an affinity for tools and measuring equipment.</li>
<li>Proficient in Microsoft Office, a good working knowledge of Excel a must.</li>
<li>Excellent communication and organizational skills working in cross-functional teams.</li>
</ul>
This is an exempt; full time position. Compensation is dependent on experience and education. Benefits include a matching 401K, health, dental, vision and paid time off.

QUALITY ENGINEER

<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
 
PI28aa863f393a-25405-38327992

MoFe Engineer

<h3>Job Description</h3>
Job Description
Overview
Now Hiring Field Service Engineer Ultrasound!Location: Washington, DC*Some regional travel may be required*Salary: Starting at $60,000 annually based on experience. Who We Are:
Tri-Imaging Solutions is at the forefront of medical imaging equipment innovation, specializing in enterprise imaging systems management. We’re committed to delivering cutting-edge solutions and empowering our team with the tools, training, and opportunities to grow. Join our dynamic team and play a vital role in advancing healthcare technology.
Why Join Us (Benefits):
<ul>
<li>
Highly competitive salary
</li>
<li>
Car/travel reimbursement
</li>
<li>
Continuing diagnostic imaging training (with a path into advanced modalities like CT, MRI, and Cath Lab)
</li>
<li>
Company-paid holidays plus PTO
</li>
<li>
Major medical/dental/vision benefits
</li>
<li>
Recognition/reward program
</li>
</ul>
Position Overview:
We are seeking a motivated Level 1 Field Service Engineer with a primary focus on ultrasound systems. This is an excellent opportunity for early-career professionals with a strong technical foundation who want to expand into other diagnostic imaging modalities over time. The right candidate will receive structured training and mentorship to build expertise across the full spectrum of imaging technology.
What You’ll Do:
<ul>
<li>
Perform installations, calibrations, inspections, and basic repairs on general ultrasound equipment
</li>
<li>
Conduct preventive maintenance in accordance with OEM specifications
</li>
<li>
Use laptop-based diagnostic tools and hand tools to assess and improve system performance
</li>
<li>
Collaborate closely with senior engineers to develop advanced troubleshooting skills
</li>
<li>
Provide excellent customer service while ensuring equipment operates to the highest safety and performance standards
</li>
<li>
Travel to client sites within the assigned territory
</li>
</ul>
What You’ll Need (Requirements):
<ul>
<li>
Associate degree in Biomedical Engineering, Electrical Engineering, or related field, or equivalent work experience
</li>
<li>
1–2 years of hands-on experience as a biomedical or ultrasound service technician
</li>
<li>
Strong mechanical aptitude and diagnostic skills
</li>
<li>
Eagerness to learn other imaging modalities such as CT, MRI, and Cath Lab
</li>
<li>
Excellent communication and teamwork abilities
</li>
<li>
Willingness to travel regionally as needed
</li>
</ul>

Field Service Engineer Ultrasound

<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

MoFe Engineer I

<h3>Job Description</h3>
Job Description
We are currently seeking a Lead Scientist / Engineer with a PhD in Systems &amp; Control, Biomedical Engineering, Applied Mathematics, or a related quantitative field, and 5–6+ years of experience in applied modeling and estimation. This role will function as a senior member of the company’s algorithm team. It will involve designing and implementing Etiometry’s next-generation physiologic risk and treatment-prediction algorithms. The position will require close collaboration with Etiometry’s data science, product, and clinical teams to translate physiologic and clinical requirements into real-time decision support tools deployed in the ICU.
Responsibilities
<ul>
<li>
Lead the design, implementation, and validation of algorithms that predict patient trajectories and responses to interventions (e.g., fluids, vasoactives, ventilator changes).
</li>
<li>
Extend Etiometry’s existing ODE-based physiologic models with advanced estimation methods (e.g., Kalman filters, Bayesian inference, particle filters).
</li>
<li>
Integrate data-driven approaches (e.g., neural networks, probabilistic ML, hybrid mechanistic/ML frameworks) with classical physiology-based models.
</li>
<li>
Translate physiologic and clinical requirements into quantitative risk indices for FDA-regulated software.
</li>
<li>
Work with real-world ICU data, including physiologic waveforms, vital signs, and laboratory values.
</li>
<li>
Mentor junior scientists and collaborate with engineers, clinical experts, and regulatory affairs to bring models from research → cleared product.
</li>
</ul>
Basic Qualifications
<ul>
<li>
PhD in Systems &amp; Control, Biomedical Engineering, Applied Mathematics, Electrical/Mechanical Engineering, or a related field.
</li>
<li>
5–6+ years of experience (industry or postdoctoral) in applied modeling, estimation, or control systems.
</li>
<li>
Strong background in dynamical systems &amp; ODE/PDE modeling.
</li>
<li>
Strong background in state estimation techniques (Kalman filters, stochastic processes, Bayesian methods).
</li>
<li>
Working knowledge of machine learning (neural networks, probabilistic ML, data-driven system identification).
</li>
<li>
Proficiency in scientific computing in Python (NumPy, SciPy, PyTorch, TensorFlow).
</li>
<li>
Strong communication and organization skills.
</li>
<li>
Proven ability to work in cross-disciplinary teams and translate theory into applied solutions.
</li>
</ul>
Desired Qualifications
<ul>
<li>
Experience working with clinical monitoring data (ICU waveforms, vital signs, laboratory data, EHR integration).
</li>
<li>
Familiarity with computational physiology or biomedical modeling.
</li>
<li>
Knowledge of medical device software lifecycle (IEC 62304, FDA 510(k)).
</li>
<li>
Experience mentoring junior scientists or leading research projects.
</li>
</ul>
About Etiometry
Etiometry is the market leader in predictive analytics for the Intensive Care Unit. Our system leverages real-time patient data to provide clinicians with actionable information that improves care for the most vulnerable patients. In use at some of the best medical institutions across three continents, the Etiometry Platform has a proven track record in improving outcomes while reducing hospital costs. Our next generation of algorithms will go beyond monitoring risk to forecasting how treatments will affect patient physiology — giving clinicians foresight to guide critical interventions. By joining Etiometry, you will be at the forefront of clinical innovation, working with a passionate team of engineers and scientists with the mission of transforming the delivery of critical care. You will become an integral part of a dynamic team whose work will directly impact patients worldwide and shape the future of ICU analytics.

Lead Algorithm Scientist Engineer

<h3>Job Description</h3>
Job Description
Are you a mechanical maestro ready to unleash your expertise? At BDC Laboratories, we invite you to immerse yourself in an exhilarating role as a Full-Time Product Evaluations Engineer III onsite in Wheat Ridge, CO. This isn’t just any gig; it’s an opportunity to innovate and solve real-world problems, all while collaborating with a vibrant team that values customer satisfaction above all.
As you dive into engaging projects that drive the biotech industry forward, you'll enjoy a competitive salary ranging from $95,000 to $112,000. Here, your ingenuity and keen eye for excellence will be recognized, not just encouraged. The thrill of working in a dynamic, energetic environment awaits you!
You will be provided great benefits such as Medical, Dental, Vision, 401(k), Health Savings Account, and Paid Time Off. Don’t miss the chance to be at the forefront of biotechnology, where every day is a new adventure. Elevate your career with us today!
Let us introduce ourselves
Biomedical Device Consultants &amp; Laboratories (<a href="http://www.bdclabs.com" target="_blank">www.bdclabs.com</a>) is a fast-growing company that offers comprehensive medical device testing services, designs verification test equipment, and produces silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding.
Your day to day as a Product Evaluations Engineer III
As a Full-Time Product Evaluations Engineer III at BDC Laboratories, your mission is to ensure that every piece of equipment meets the rigorous demands of our biotech studies. You’ll assess the suitability of equipment for data acquisition, ensuring compliance with protocol specifications. Your expertise will keep our laboratory inspection-ready, as you guarantee all equipment is designed for optimal performance, adequately cleaned, and meticulously maintained. You'll lead the way in establishing innovative test methods, preparing meticulous protocols, and maintaining a contamination-free environment.
Each data entry you record will enhance the integrity of our research, as you diligently verify and analyze experimental data. Additionally, you will play a key role in supporting our Quality Management System and participating in audits, all while setting an exemplary standard for your colleagues. This position is not just about maintaining excellence; it's about driving innovation in a fun, high-performance culture.
Requirements for this Product Evaluations Engineer III job
To thrive as a Full-Time Product Evaluations Engineer III at BDC Laboratories, you’ll need a robust toolkit of skills and experiences. A minimum of a Bachelor’s Degree in engineering or a science-based field, coupled with relevant years of experience, establishes your foundational expertise. Familiarity with quality system requirements like ISO 17025 and 21 CFR Part 58 is preferred, while knowledge of ISO 13485 and 21 CFR Part 820 will set you apart. Your analytical and problem-solving prowess will be crucial, allowing you to perform statistical analyses and interpret technical regulations effectively. Strong verbal and written communication skills are essential for drafting clear protocols and presenting information to both managers and team members.
Additionally, your ability to mentor and manage fellow engineers will contribute to a dynamic and collaborative team environment. Embrace this opportunity to lead with integrity in a forward-thinking biotech space!
Knowledge and skills required for the position are: 
<ul>
<li>Minimum of a Bachelor’s Degree in an engineering field and 4 years of experience; or minimum of a Master’s Degree in an engineering field and 2 years of experience; or minimum of a Bachelor’s Degree in a science-based field and 6 years of relevant experience; or an Associate Degree with a minimum of 10 years of relevant experience.</li>
<li>Understanding of quality system requirements including ISO 17025 and 21 CFR part 58 is preferred. Experience in 21 CFR Part 820 and Part 11, ISO 13485 and other relevant international standards desirable.</li>
<li>Must be organized with excellent analytical and problem-solving abilities and the ability to perform and report basic statistical analyses.</li>
<li>Ability to read analyze and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members. Ability to effectively draft protocols and reports.</li>
<li>Ability to define problems, collect data, establish facts and draw valid final conclusions.</li>
<li>Strong verbal and writing skills and good interpersonal and leadership skills.</li>
<li>Proficiency with a Windows environment(Word and Excel) required.</li>
<li>Experience managing other engineers.</li>
</ul>
Get started with our team!
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