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<h3>Job Description</h3>
Job Description
Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market. 
Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.
We are growing and hiring a Senior Quality Engineer to join us in Bedford, MA. As a Senior Quality Engineer at Lexington Medical, you will drive the quality system and design assurance activities and play a key role in maintaining a world-class quality management system and building a quality function that is core to the company's success.
Responsibilities:
• Drive design quality assurance activities throughout the product lifecycle. Lead design quality activities for product development, starting from the requirements phase through development, V&amp;V, design transfer, and commercialization. • Provide expertise in Risk Management Files, Design Verification and Validation, Statistical Methods, Design Controls, and Usability activities for new product introductions as well as commercially available products. • Provide guidance on statistical techniques by participating in V&amp;V and engineering testing sampling plans. • Review and support product requirements, test documentation, and design reviews. • Provide input for interpretation of global standards and guidelines. • Assist with the Corrective and Preventive Action (CAPA) process, including identification, investigation, root cause analysis, implementation, and effectiveness monitoring. • Conduct and support internal audits to ensure compliance with quality management system requirements and identify areas for improvement. • Participate in external audits, including preparation, coordination, and response to findings from regulatory bodies or third-party auditors. • Assist with post-market surveillance activities, including planning, data collection, trend analysis, and risk assessments. • Create/review engineering and document change orders. 
Qualifications:
• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field. • 5+ years of experience in design quality engineering in the medical device industry, including experience supporting the developing and maintenance of medical devices that have software capabilities. • Experience developing and implementing quality management systems. • Experience in new product development and introduction (NPD/NPI) and production transfer. • Strong working knowledge of US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MDR), ISO 13485, ISO 14971, IEC 60601, and IEC 62366. • Experience with sterilization validation and biocompatibility testing a plus. • Demonstrated knowledge of design controls, process validation, risk management, CAPA processes, complaint handling, and change control. • Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies. • Experience with internal and external auditing processes, including audit preparation, execution, and follow-up. • Strong team orientation and ability to lead in a cross-functional environment. • CQE or equivalent certifications a plus; Arena eQMS experience a plus. • Clean room and/or microbiology experience a plus.

Senior Quality Engineer

<h3>Job Description</h3>
Job Description
Project Engineer III- Life Sciences Are you ready for your next adventure? At OFD Life Sciences, innovation isn’t just a buzzword, it’s our foundation. We are a purpose-driven company with six decades of expertise in freeze-drying technology. Best known as the makers of Mountain House© meals, we are experts in advanced lyophilization solutions that can help people around the world live healthier lives. Our headquarters in Albany, Oregon sits at the crossroads of science and nature, surrounded by breathtaking landscapes that fuel bold ideas and innovative breakthroughs. We're driven by a commitment to quality, creativity, and continuous improvement, and we're always looking ahead to what's next.&nbsp; We’re proud of our legacy, but our future is even more exciting. If you're passionate and ready to advance our Life Sciences capabilities, OFD Life Sciences isn't just a place to work, it's where your adventure&nbsp;begins.&nbsp; What? The Project Engineer III leads capital projects that enhance facility assets and expand life sciences processing capabilities within a CDMO environment. This role integrates project engineering with validation responsibilities, including FAT, SAT, and IQ/OQ/PQ activities, ensuring compliance with cGMP and regulatory standards. The role collaborates closely with cross-functional teams to deliver compliant, efficient, and scalable solutions that support operational excellence. Emphasis is placed on driving innovation while maintaining safety, quality, and environmental integrity. Main aspects of the role include:
<ul>
<li>Executes all aspects of capital projects as assigned, including cost estimates, scope definition, capital appropriation requests, design specifications, bidding, budget management, contractor management, installation, and start-up.</li>
<li>Build and maintain relationships with reliable contractors, vendors, and fabricators.</li>
<li>Research and identify new technologies and equipment solutions to enhance operational efficiency.</li>
<li>Lead and perform equipment and process validation activities for both new and existing systems, including the creation, review, and approval of validation documentation.</li>
<li>Develop and implement validation protocols and reports to ensure compliance with cGMP, CFR, and other regulatory standards.</li>
<li>Support and execute technology transfer activities for new products and processes, including scale-up and troubleshooting.</li>
<li>Provide technical expertise and support to R&amp;D, manufacturing, and maintenance teams, driving improvements across laboratory, processing, and packaging systems.</li>
<li>Ensure all work complies with applicable local, state, and federal codes and regulations, including OSHA, USDA, FDA, UBC, SQF, and ISO requirements.</li>
<li>Utilize asset management software to input new assets, maintain accurate records, analyze data, and reference historical information to guide project decisions.</li>
</ul>
You!
<ul>
<li>Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or Biomedical) or closely related technical field is required. </li>
<li>Minimum of 6 years of project engineering experience in the life sciences industry, with at least 3 years focused on validation activities.</li>
<li>Proven success in scoping, managing, and delivering capital projects within the life sciences sector.</li>
<li>Extensive experience integrating new products and projects into existing operations, ensuring seamless transitions and optimal outcomes.</li>
<li>Advanced proficiency in CAD software for design and technical documentation.</li>
<li>Exceptional ability to design, implement, and optimize processes and equipment in a manufacturing environment.</li>
<li>Excellent organizational, interpersonal, and problem-solving skills, with the ability to thrive in a fast-paced, dynamic setting.</li>
<li>Self-motivated and able to work independently while collaborating effectively across teams.</li>
<li>Commitment to embodying and promoting OFD’s cultural values in daily work.</li>
</ul>
Interested? Apply today with your resume at Careers | Oregon Freeze Dry. You can also explore more about our company and employee benefits on our website. Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Oregon Freeze Dry wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. Criminal background checks may be completed on all applicants. Oregon Freeze Dry is a drug free workplace.
AFFIRMATIVE ACTION / EQUAL OPPORTUNITY EMPLOYER
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Project Engineer III- Life Sciences

<h3>Job Description</h3>
Job Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Process Engineer to work for a leading Orange County area medical device company.
Pay Rate: $33-50/hour Contract:&nbsp;3-6 months
 Summary The Process Engineer will lead multiple aspects of manufacturing equipment and process design and validation. This position will be responsible for supporting the sustaining manufacturing and operations and working closely with a cross functional team while maintaining equipment uptime and improving upon product cost, quality, and safety. &nbsp;
Responsibilities • Responsible for developing manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions. • Designs, executes and documents process validation protocols in support of quality and regulatory requirements. • Provides on-demand pilot line support, managing manufacturing metrics (yields, cycle times, capacity, bottlenecks), ensuring adherence to quality and compliance procedures, identifying and implementing continuous process improvements, deploying new fixture and tooling, and supporting manufacturing documentation updates. • Identifies and develops the crucial equipment related to new product development and maintains appropriate uptime for current equipment. • Assists pilot line technicians and engineers on manufacturing problems. Purchases and designs equipment that meets safety and environmental requirements. • Responsible for communicating business related issues or opportunities to next management level • Responsible for ensuring personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. • Lead or support troubleshooting activities and process improvements. Perform root cause analysis of failures. Work on special projects as requested by management. • Assist with other responsibilities and/or projects as the need arises. &nbsp;
Experience/Requirements •Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field is required •Minimum of 2 years of industry process engineer experience is required •Experience with commercial or pilot manufacturing lines, technical report writing, statistical analysis and data evaluation is required. •Knowledge of good manufacturing practices and documentation is required •Strong Project Management experience and skills are preferred. •Ability to travel up to 10%, international and domestic, required.
Company DescriptionBioPhase specializes in recruiting top talented professionals in the Pharmaceutical, Medical Device and Biotech industry for California. We maintain a reputation of excellence in the industry by developing long term, personal relationships with our clients, candidates, and employees. 
<h3>Company Description</h3>
BioPhase specializes in recruiting top talented professionals in the Pharmaceutical, Medical Device and Biotech industry for California. We maintain a reputation of excellence in the industry by developing long term, personal relationships with our clients, candidates, and employees.

Process Engineer

<h3>Job Description</h3>
Job DescriptionSalary: $150 - $160k + 15% 
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care.With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the worlds first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
The Principal Sustaining Engineer is a highly skilled and experienced technical leader responsible for supporting and improving existing products throughout their lifecycle. This role is pivotal in ensuring the continued performance, safety, and regulatory compliance of Anteris Technologies medical devices. The engineer will work cross-functionally with Quality, Manufacturing, Regulatory, Quality and other teams to drive product improvements, cost reductions, and design optimizations.
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. Join us in our mission to revolutionize structural heart solutions.
Key Responsibilities:
<ul>
<li>Lead sustaining engineering activities, including design modifications, process improvements, and component/material changes, ensuring product quality and reliability.</li>
<li>Provide technical expertise to resolve product performance issues, field complaints, and non-conformances.</li>
<li>Conduct root cause analysis and implement corrective and preventive actions (CAPA) for product issues.</li>
<li>Collaborate with cross-functional teams to assess and implement design changes, ensuring compliance with regulatory requirements.</li>
<li>Support manufacturing teams, both internal and contract manufacturing, in troubleshooting production issues and optimizing processes.</li>
<li>Evaluate and qualify alternate materials, suppliers, and manufacturing processes to ensure continuity of supply and cost-effectiveness.</li>
<li>Prepare and review technical documentation, including engineering change orders (ECOs), risk assessments, test protocols, and validation reports.</li>
<li>Ensure compliance with medical device regulations (FDA, ISO 13485, MDR) and contribute to audits and regulatory submissions as needed.</li>
<li>Mentor junior engineers and contribute to knowledge sharing within the R&amp;D team.</li>
<li>Stay updated on industry trends, emerging technologies, and regulatory changes to drive continuous improvement initiatives.</li>
</ul>
Skills, Knowledge, Experience, Qualifications
<ul>
<li>Bachelors degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline. Masters degree preferred.</li>
<li>Minimum of 8-10 years of experience in R&amp;D, sustaining engineering, or product development within the medical device industry.</li>
<li>Deep understanding of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and EU MDR.</li>
<li>Strong knowledge of risk management (ISO 14971), design control, and verification/validation processes.</li>
<li>Proficiency in engineering tools such as CAD (SolidWorks), FMEA, and statistical analysis.</li>
<li>Experience working in a cross-functional environment and leading product improvement initiatives.</li>
<li>Strong analytical and problem-solving skills, with a hands-on approach to technical challenges.</li>
<li>Excellent communication and project management skills, with the ability to work in a fast-paced, regulated environment.</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 Offerings</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: We may require proof of COVID-19 vaccination to comply with health institutions, 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. Wehave 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.

Principal Sustaining Engineer

<h3>Job Description</h3>
Job DescriptionWe are seeking a highly skilled and detail-oriented professional to support the development and optimization of tissue processing methods for implantable medical devices. This role focuses on ensuring the safety, quality, and regulatory compliance of animal-derived tissues used in advanced medical applications. Key Responsibilities:
<ul>
<li>Develop, refine, and validate tissue processing protocols using animal-derived tissues for use in implantable medical devices.</li>
<li>Select and assess processing reagents and chemicals to ensure compatibility with biocompatibility, sterilization, and regulatory requirements.</li>
<li>Partner with cross-functional teams—including R&amp;D, Quality, Regulatory Affairs, and Manufacturing—to design and scale processes from pilot to full-scale production.</li>
<li>Lead or contribute to pilot and production line activities, ensuring process robustness and compliance with GMP, ISO, and other relevant standards.</li>
<li>Conduct risk assessments and support process validation activities (IQ/OQ/PQ); drive continuous improvement initiatives to enhance product quality and reduce variability.</li>
<li>Provide technical expertise in resolving tissue-related quality issues, including support for investigations, CAPAs, and root cause analysis.</li>
<li>Stay current on industry trends, evolving regulations, and best practices in tissue processing and preservation.</li>
<li>(Preferred) Apply specialized expertise in cardiovascular tissue valve processing, including decellularization, sterilization, and preservation techniques.</li>
</ul>
 Must Haves:
<ul>
<li>Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Biological Sciences, or a related field.</li>
<li>Master's degree is preferred.</li>
<li>5- 7 years of hands-on experience in tissue processing within the medical device, biotech, or biopharma industries.</li>
<li>Experience with cardiovascular tissue valve processing (e.g., porcine or bovine valves), including decellularization and preservation technologies is preferred.</li>
<li>Proven track record in animal tissue processing process development, including handling, cleaning, preservation, and sterilization.</li>
<li>Direct experience in pilot or manufacturing line setup and operation for tissue-based products.</li>
<li>Demonstrated understanding of and ability to work with common tissue processing chemicals such as fixatives, detergents, and sterilants (e.g., glutaraldehyde, ethanol, peracetic acid)</li>
<li>Working knowledge of FDA regulations, ISO 13485, and GMP practices.</li>
<li>Excellent problem-solving, technical writing, and cross-functional collaboration skills.</li>
</ul>
 Salary of $100,000 - $140,000 annually + bonus

Tissue Processing Engineer

<h3>Job Description</h3>
Job Description
Position Title:&nbsp;ISE III- Haverhill, MA&nbsp;
Salary:&nbsp;$115000-$130000
Other Forms of Compensation:
Join Intelas, a Compass One Healthcare company.
 Intelas, a Compass One Healthcare company, delivers smarter asset management by blending expert service teams with intelligent, data-driven strategies that help hospitals improve uptime, simplify oversight, and make more informed capital decisions. Our programs support 100% regulatory compliance and drives 98% equipment uptime—so clinicians can focus on care, not equipment issues.
 We support nearly 4,500 healthcare sites nationwide—from large, campus-based acute care hospitals to system-integrated outpatient clinics. With more than 1.15 million medical devices managed, we provide the clarity and consistency needed in today’s rapidly evolving healthcare environment.
 Join Intelas—where your career thrives, your potential is unleashed, and your work directly supports patient care. Whether you're just starting out or are a seasoned professional, our people-first approach ensures opportunities for continuous growth, development, and fulfillment.&nbsp;
 Explore more at intelashealth.com.
Job Summary
Key Responsibilities:
<ul>
<li>Perform planned preventive maintenance, calibrations where certification may be required and electrical safety inspections on imaging and related equipment in compliance with established standards</li>
<li>Perform major repairs by replacing defective components, readjust components to manufacturer’s specifications using appropriate tools and measuring instruments. May require certification in order to complete repairs</li>
<li>Assist with diagnostic imaging cross training of BMET Technicians</li>
<li>Confers with manufacturer’s representatives and equipment operators to resolve equipment related problems</li>
<li>Provide emergency on-call responsibilities</li>
<li>Research and initiate orders for repair parts, working within established budget parameters</li>
<li>Conducts and compiles Quality Assurance records and reports necessary for compliance with specifications and policies</li>
<li>Document all significant asset related actions in compliance with department practices</li>
<li>Must be capable of performing all the duties and responsibilities of a BMET III</li>
</ul>
Preferred Qualifications:
<ul>
<li>Associates degree in Electronics/Imaging Technology, Biomedical Equipment Technology, or military training</li>
<li>Prior experience of at least seven to ten years experience with various imaging equipment manufacturers or other appropriate related experience</li>
<li>Minimum of seven years experience in the repair of radiology equipment and prior biomedical experience</li>
<li>Should possess specialized knowledge in several specialized modalities such as radiology, MRI, nuclear medicine, ultrasound, CT, cath. lab., linear accelerators, etc. </li>
<li>Prefer certification (CRES) in these different modalities</li>
<li>Good communication and strong customer service skills</li>
<li>Ability and willingness to serve "on-call" duty as required</li>
<li>Must be willing to serve as a technical resource to others in areas of specialty or certification(s)</li>
</ul>
Apply to Intelas today!
 Intelas is a member of Compass Group USA
 Click here to Learn More about the Compass Story
Associates at Intelas are offered many fantastic benefits.&nbsp;
•&nbsp;&nbsp; &nbsp;Medical •&nbsp;&nbsp; &nbsp;Dental •&nbsp;&nbsp; &nbsp;Vision •&nbsp;&nbsp; &nbsp;Life Insurance/ AD •&nbsp;&nbsp; &nbsp;Disability Insurance •&nbsp;&nbsp; &nbsp;Retirement Plan •&nbsp;&nbsp; &nbsp;Flexible Time Off •&nbsp;&nbsp; &nbsp;Holiday Time Off (varies by site/state) •&nbsp;&nbsp; &nbsp;Associate Shopping Program •&nbsp;&nbsp; &nbsp;Health and Wellness Programs •&nbsp;&nbsp; &nbsp;Discount Marketplace •&nbsp;&nbsp; &nbsp;Identity Theft Protection •&nbsp;&nbsp; &nbsp;Pet Insurance •&nbsp;&nbsp; &nbsp;Commuter Benefits •&nbsp;&nbsp; &nbsp;Employee Assistance Program •&nbsp;&nbsp; &nbsp;Flexible Spending Accounts (FSAs) •&nbsp;&nbsp; &nbsp;Paid Parental Leave •&nbsp;&nbsp; &nbsp;Personal Leave
 Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws.&nbsp;For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information.&nbsp;
 Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.
 Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.
Applications are accepted on an ongoing basis.
 Intelas maintains a drug-free workplace.
Req ID: 1400473 Intelas &nbsp; ASHLEY VAVROCK &nbsp; [[req_classification]]

Imaging Service Engineer III

<h3>Job Description</h3>
Job Description
Position Title:&nbsp;ISE III- Boston, MA&nbsp;
Salary:&nbsp;$120,000 to $135,000
Other Forms of Compensation:
Join Intelas, a Compass One Healthcare company.
 Intelas, a Compass One Healthcare company, delivers smarter asset management by blending expert service teams with intelligent, data-driven strategies that help hospitals improve uptime, simplify oversight, and make more informed capital decisions. Our programs support 100% regulatory compliance and drives 98% equipment uptime—so clinicians can focus on care, not equipment issues.
 We support nearly 4,500 healthcare sites nationwide—from large, campus-based acute care hospitals to system-integrated outpatient clinics. With more than 1.15 million medical devices managed, we provide the clarity and consistency needed in today’s rapidly evolving healthcare environment.
 Join Intelas—where your career thrives, your potential is unleashed, and your work directly supports patient care. Whether you're just starting out or are a seasoned professional, our people-first approach ensures opportunities for continuous growth, development, and fulfillment.&nbsp;
 Explore more at intelashealth.com.
Job Summary
Key Responsibilities:
<ul>
<li>Perform planned preventive maintenance, calibrations where certification may be required and electrical safety inspections on imaging and related equipment in compliance with established standards</li>
<li>Perform major repairs by replacing defective components, readjust components to manufacturer’s specifications using appropriate tools and measuring instruments. May require certification in order to complete repairs</li>
<li>Assist with diagnostic imaging cross training of BMET Technicians</li>
<li>Confers with manufacturer’s representatives and equipment operators to resolve equipment related problems</li>
<li>Provide emergency on-call responsibilities</li>
<li>Research and initiate orders for repair parts, working within established budget parameters</li>
<li>Conducts and compiles Quality Assurance records and reports necessary for compliance with specifications and policies</li>
<li>Document all significant asset related actions in compliance with department practices</li>
<li>Must be capable of performing all the duties and responsibilities of a BMET III</li>
</ul>
Preferred Qualifications:
<ul>
<li>Associates degree in Electronics/Imaging Technology, Biomedical Equipment Technology, or military training</li>
<li>Prior experience of at least seven to ten years experience with various imaging equipment manufacturers or other appropriate related experience</li>
<li>Minimum of seven years experience in the repair of radiology equipment and prior biomedical experience</li>
<li>Should possess specialized knowledge in several specialized modalities such as radiology, MRI, nuclear medicine, ultrasound, CT, cath. lab., linear accelerators, etc. </li>
<li>Prefer certification (CRES) in these different modalities</li>
<li>Good communication and strong customer service skills</li>
<li>Ability and willingness to serve "on-call" duty as required</li>
<li>Must be willing to serve as a technical resource to others in areas of specialty or certification(s)</li>
</ul>
Apply to Intelas today!
 Intelas is a member of Compass Group USA
 Click here to Learn More about the Compass Story
Associates at Intelas are offered many fantastic benefits.&nbsp;
•&nbsp;&nbsp; &nbsp;Medical •&nbsp;&nbsp; &nbsp;Dental •&nbsp;&nbsp; &nbsp;Vision •&nbsp;&nbsp; &nbsp;Life Insurance/ AD •&nbsp;&nbsp; &nbsp;Disability Insurance •&nbsp;&nbsp; &nbsp;Retirement Plan •&nbsp;&nbsp; &nbsp;Flexible Time Off •&nbsp;&nbsp; &nbsp;Holiday Time Off (varies by site/state) •&nbsp;&nbsp; &nbsp;Associate Shopping Program •&nbsp;&nbsp; &nbsp;Health and Wellness Programs •&nbsp;&nbsp; &nbsp;Discount Marketplace •&nbsp;&nbsp; &nbsp;Identity Theft Protection •&nbsp;&nbsp; &nbsp;Pet Insurance •&nbsp;&nbsp; &nbsp;Commuter Benefits •&nbsp;&nbsp; &nbsp;Employee Assistance Program •&nbsp;&nbsp; &nbsp;Flexible Spending Accounts (FSAs) •&nbsp;&nbsp; &nbsp;Paid Parental Leave •&nbsp;&nbsp; &nbsp;Personal Leave
 Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws.&nbsp;For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information.&nbsp;
 Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.
 Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.
Applications are accepted on an ongoing basis.
 Intelas maintains a drug-free workplace.
Req ID: 1418228 Intelas &nbsp; ASHLEY VAVROCK &nbsp; [[req_classification]]

<h3>Job Description</h3>
Job Description
(ID: 2025-0413)
 
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Senior Healthcare Data Engineer to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translation Sciences (NCATS) located in Rockville, MD.
Benefits We Offer:
<ul>
<li>100% Medical, Dental &amp; Vision Coverage for Employees</li>
<li>Paid Time Off and Paid Holidays</li>
<li>401K match up to 5%</li>
<li>Educational Benefits for Career Growth</li>
<li>Employee Referral Bonus</li>
<li>Flexible Spending Accounts:
<ul>
<li>Healthcare (FSA)</li>
<li>Parking Reimbursement Account (PRK)</li>
<li>Dependent Care Assistant Program (DCAP)</li>
<li>Transportation Reimbursement Account (TRN)</li>
</ul>
</li>
</ul>
Key Responsibilities: 
Design and Automation of Data Pipelines: 
<ul>
<li>
Build and maintain scalable and efficient data pipelines for clinical and research datasets. 
</li>
<li>
Automate the extraction, transformation, and loading (ETL) processes to ensure timely and reliable data delivery, while optimizing workflows for downstream analysis.
</li>
</ul>
Data Ingestion, Standardization, and Harmonization: 
<ul>
<li>
Ingest large-scale datasets from diverse clinical and research sources. 
</li>
<li>
Collaborate with data science teams to harmonize data across systems
</li>
<li>
Implement best practices for cleaning and standardizing data to enable consistent analytics.
</li>
</ul>
Standards Compliance and Modeling: 
<ul>
<li>
Ensure datasets meet healthcare and research compliance requirements by aligning data with established Common Data Models such as CDISC and OMOP. 
</li>
<li>
Work closely with clinical data teams to maintain integrity and usability of standardized datasets.
</li>
</ul>
Workflow Development and Reproducibility: 
<ul>
<li>
Develop, optimize, and automate workflows using tools like Snakemake or Nextflow. 
</li>
<li>
Containerize pipelines using Docker to support reproducibility and scalability across research and production environments.
</li>
<li>
Promote continuous integration and deployment within data workflows.
</li>
</ul>
Collaboration and Documentation: 
<ul>
<li>
Work closely with multidisciplinary teams including data scientists, biostatisticians, and software engineers to align data infrastructure with project needs. 
</li>
<li>
Maintain comprehensive documentation of pipeline architectures and workflow logic to ensure clarity, transparency, and reproducibility.
</li>
</ul>
Required:
<ul>
<li>
Bachelor's degree in computer science, Data Engineering, Bioinformatics, or a related field, with 6-10+ years of relevant experience; or a Master's degree with 4-7 years of experience.
</li>
<li>
Proven ability to design, build, and maintain scalable data pipelines and automate ETL processes.
</li>
<li>
Hands-on experience working with clinical or research data and familiarity with healthcare data standards and Common Data Models (e.g., CDISC, OMOP).
</li>
<li>
Familiarity with big data frameworks like Apache Spark or Hadoop.
</li>
<li>
Strong skills in Python, SQL, and shell scripting (e.g., Bash).
</li>
<li>
Experience using Docker to containerize data workflows for reproducibility and scalability.
</li>
<li>
Proficiency with version control systems like Git and continuous integration practices.
</li>
</ul>
Preferred:
<ul>
<li>
Experience with cloud platforms (e.g., AWS, GCP, Azure) for large-scale data processing.
</li>
<li>
Proficiency with workflow management systems such as Snakemake, Nextflow, or similar tools.
</li>
</ul>
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: <a href="mailto:careers@axleinfo.com" target="_blank">careers@axleinfo.com</a>
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.
#INDPSD
Salary Range$115,000—$155,000 USD

Senior Healthcare Data Engineer

<h3>Job Description</h3>
Job DescriptionSalary: 
Purpose
The Senior Project Engineer will be responsible for supporting existing products and the development of new products. This will include leading project management, product development, and verification &amp; validation activities. 
Responsibilities
<ul>
<li> Manage and execute product development projects from ideation to market launch. </li>
<li> Identify and develop project deliverables required for the launch of new products in collaboration with the Quality Assurance and Operations departments.</li>
<li> Lead project management activities on assigned projects including the project schedule, budget, work products and </li>
<li> Execute projects following design control practices and develop necessary project inputs and outputs required for each development phase. This includes collecting customer and market feedback to identify critical product characteristics.</li>
<li> Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. </li>
<li> Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.</li>
<li> Manage and execute product development projects from ideation to market launch. </li>
<li> Identify and develop project deliverables required for the launch of new products in collaboration with the Quality Assurance and Operations departments.</li>
<li> Lead project management activities on assigned projects including the project schedule, budget, work products and </li>
<li> Execute projects following design control practices and develop necessary project inputs and outputs required for each development phase. This includes collecting customer and market feedback to identify critical product characteristics.</li>
<li> Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports. </li>
<li> Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes.</li>
<li> Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary. </li>
<li> Perform other duties as assigned.</li>
</ul>
Skills
<ul>
<li> Project management experience. </li>
<li> Ability to present complex ideas.</li>
<li> Strong technical writing ability.</li>
<li> Knowledge of manufacturing environment and validation procedures.</li>
<li> Strong analytical and creative thinking skills. </li>
<li> Ability to work in a fast-paced environment. </li>
<li> Ability to work independently and in a team environment. </li>
<li> Proficient in Microsoft Office.</li>
<li> Experience working with vendors and suppliers. </li>
<li> Ability to secure and maintain a favorable background investigation and clearance.</li>
</ul>
 
Qualifications/Requirements
<ul>
<li> Bachelors degree in biomedical engineering, tissue engineering, mechanical engineering, or related field, from an accredited college or university required.</li>
<li> At least 5-6 years of experience in product development, or a related field, required. </li>
<li> 4 years of experience in project management required.</li>
<li> Experience in mechanical design and 3D modeling CAD Software. </li>
<li> Experience in manufacturing process design. </li>
<li> Working knowledge of design control processes.</li>
<li> Experience with allografts and/or medical devices preferred. </li>
<li> Clearance of favorable background investigation required.</li>
</ul>

Senior Project Engineer - Tissue

<h3>Job Description</h3>
Job Description Clinical Research EngineerResponsibilities:
<ul>
<li>Work closely with clinical research scientists, associates, and other team members to design and execute clinical studies</li>
<li>Provide data monitoring tools and data analysis tools</li>
<li>Creates tools to streamline data processes</li>
<li>Authors tool qualification reports</li>
<li>Monitors study datasets to main high data quality</li>
<li>Analyzes signal quality of biosensor data</li>
<li>Provide support to clinical research organizations during planning and execution of clinical studies</li>
<li>Performs clinical data analysis and provides statistical inferences as needed </li>
</ul>
Qualifications:
<ul>
<li>Experience working with cross-functional teams</li>
<li>Experienced with clinical study datasets Understanding of wearables/sensing technologies/health sensors</li>
<li>Experienced with cloud data storage solutions (e.g., Amazon AWS)</li>
<li>Familiar with RESTful API</li>
<li>Familiar with HIPAA requirements, GCP, and IRB study approval</li>
<li>Experience with statistical software and basic statistical understanding</li>
<li>Sound understanding of clinical study protocol design and execution requirements in a regulated industry</li>
<li>Microsoft Office applications (Word, Excel, PowerPoint, Outlook); and other applicable applications</li>
<li>Experience with MATLAB, Python, Java, or similar</li>
<li>Ability to work in a fast-paced environment</li>
<li>Self-motivated individual with the ability to thrive in a dynamic team-based environment. </li>
</ul>
Education:
<ul>
<li>Bachelor’s/Master’s/PhD Degree in an engineering field (e.g., computer science, biomedical engineering, electrical engineering)</li>
<li>Min. 5 years of experience with Bachelors</li>
<li>Min. 2 years of experience with a Masters or PhD</li>
</ul>
Compensation: $58 - $78.24 per hour ID#: 36183161

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