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<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]]

Imaging Service Engineer III

<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
Riverpoint Medical in Portland, Oregon is looking to hire a Process Engineer III. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. Riverpoint Process Engineer III is responsible for driving proactive improvements to internal systems, processes and new equipment validations. The PE will collaborate with Operations, New Product Development, Quality, and Regulatory teams to produce robust solutions towards process improvement.
Duties &amp; Responsibilities:
<ul>
<li>Plan, conduct, and manage projects in support of the company's strategic plan through implementation of the ECO processes.</li>
<li>Complete engineering projects by organizing and controlling project elements and coordinating activities (internal and external) of the project team.</li>
<li>Understand customer requirements and effectively implement them into the Riverpoint QMS system.</li>
<li>Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.</li>
<li>Assist in the management of compliance, quality control, and quality assurance standards and specifications.</li>
<li>Engage outside contracting services in support of project needs, i.e. analytical laboratories, consultants, material suppliers and equipment suppliers. </li>
<li>Build effective relationships with these resources to meet delivery and budgetary goals.</li>
<li>Ensure completion of new product additions across all build documentation, labeling, and ERP functions for effective transfer to production.</li>
<li>Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.</li>
</ul>
Education and Qualifications:
<ul>
<li>Bachelor’s degree or equivalent work experience in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering, graduate degree preferred.</li>
<li>Previous experience working with medical devices, product development, reprocessing and/or manufacturing (4-10 years).</li>
<li>Regulatory Experience working in an FDA regulated environment, or similar (4-10 years).</li>
<li>Experience executing equipment and process validation activities such as IQ/OQ/PQ</li>
<li>Exposure to the FDA 510(k) process or other regulatory submissions</li>
<li>Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development</li>
<li>Prior experience in medical device sterilization, sealing and/or packaging preferred.</li>
</ul>
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Process Engineer III

<h3>Job Description</h3>
Job DescriptionCompany Description 
About Smiths Interconnect:
Smiths Interconnect,&nbsp;is a global leader in the design and manufacture of high-performance interconnect solutions. Our products are used in mission-critical applications across industries such as aerospace, defense, telecommunications, and industrial markets. At Smiths Interconnect, we are committed to innovation, quality, and providing cutting-edge solutions that connect the world’s most demanding systems.
Smiths Interconnect is part of Smiths Group. For over 170 years, Smiths has been pioneering progress by engineering for a better future. We serve millions of people every year, to help create a safer, more efficient and productive, and better-connected world across four global markets: energy, security &amp; defense, space &amp; aerospace and general industrial. Listed on the London Stock Exchange, Smiths employs c.16,000 colleagues in over 50 countries.&nbsp;
Job Description 
Job Purpose: 
Provides engineering expertise in assigned areas to ensure that all products are designed, procured, and built in accordance with customer and company quality requirements for sales growth and profitability.
Responsibilities: 
<ul>
<li>Support, contribute to and promote a safe work environment and Demonstrate behaviors consistent with company policies.</li>
<li>Investigate product-related problems and suggest solutions to the Engineering Manager or Director using industry-standard software to assess and optimize the thermal and mechanical performance of semiconductor components and systems while meeting other engineering requirements.</li>
<li>Design and develop new semiconductor products and redesign existing products to meet customer needs and specifications by creating detailed 3D models and engineering drawings ensuring accuracy and compliance with industry standards.</li>
<li>Design and develop revolutionary heat dissipation solutions, showcasing expertise in advanced heat sinks, liquid cold plate, thermal interfaces, and state-of-the-art cooling systems.</li>
<li>Perform, create, and update product design guidelines, customer standards, and analytical reports as assigned.</li>
<li>Participate in and contribute to team training, development, mentoring and audits.</li>
<li>Take charge of thermal management projects, providing strategic guidance, coordinating cross-functional teams, and ensuring successful project completion within aggressive timelines.</li>
<li>Evaluate and select appropriate materials for thermal management, considering factors such as thermal conductivity, heat dissipation, reliability etc. and conduct training sessions to share knowledge regarding materials and their application.</li>
<li>Conduct FEA (Finite Element Analysis) simulations to analyze, investigate potential failure modes and optimize the structural integrity of semiconductor components and systems thus providing insights to enhance designs for structural performance.</li>
<li>Collaborate with organizational stakeholders (Production, Quality, Marketing and Sales) and external customers to ensure the practicality and efficiency of designs for production.</li>
<li>Review drawings and documentation for compliance with project specifications and company policies and procedures.</li>
<li>Issues Engineering Change Release Notifications (ECN's) • Perform, create, and update product design guidelines, customer standards, and / or analytical reports as assigned.</li>
<li>Compliance and participation in all company EHS programs, policies, procedures, and training requirements</li>
</ul>
Up to 20% domestic travel may be required. 
Telecommuting permitted up to 20%. 
Qualifications 
Technical Knowledge, Skills, and Abilities:
Employer will accept a Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering or a related field and 5 years of progressive, post-baccalaureate experience in the job offered or in an Engineering III Materials-related occupation.
In the alternative, Employer will accept a Master’s degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering or a related field and 6 months of experience in the job offered or in an Engineering III Materials-related occupation.
Position requires demonstrable experience in each of the following:
<ul>
<li>Utilizing the computer-aided engineering design software SolidWorks 3D;</li>
<li>Compliance with ASME GD&amp;T standards.</li>
<li>Utilizing Finite Element Analysis (structural, thermal and fluid);</li>
<li>Microsoft Office products including Word, Excel, and PowerPoint;</li>
<li>Knowledgeable in advanced materials and product design development activities including advanced process and manufacturing development technology;</li>
<li>Knowledge of plastics, molding, stampings, plating, cable assembly and terminations;</li>
<li>Knowledge of contact technologies and contact physics theory;</li>
<li>Performing Root Cause Analysis; and</li>
<li>Hands-on prototype development experience.</li>
</ul>
Position requires completion of a university-level course, research project, internship, or thesis, or work-related experience, with emphasis in thermal energy or heat transfer.
Up to 20% domestic travel may be required. 
Telecommuting permitted up to 20%. 
 Additional Information 
All your information will be kept confidential according to EEO guidelines.
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.
At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)

Engineer III Materials

<h3>Job Description</h3>
Job Description
About the role:
The Product Development Engineer drives the design and development, validation, and commercialization of custom ordered textile components, including new designs, material conversion, process optimization, process qualification and quality compliance. Working regularly with the business team, clients, contract manufacturers, internal operation, quality engineering to deliver tasks and quality documents in accordance to the integrated product development process (IPDP).
What you’ll do:
<ul>
<li>Lead and manage multiple projects for New Product Development in various stages of the product lifecycle in line with agreed commitments to respective clients.</li>
<li>Communicates to Management and Core team members of the status of assigned product development programs.</li>
<li>Develop textile designs utilizing textile design/engineering background and engineering principles, further advance textile components and develop finishing techniques as needed for client’s end application. </li>
<li>Partners with a cross-functional team to facilitate a transition of manufacturing process from development groups to commercial groups per IPDP while maintaining collaborative working relationships.</li>
<li>Responsible for design of process that is scalable to a production environment based on client design and volume requirements.</li>
<li>Responsible for communicating manufacturing and process development status, expectations, and constraints internally and externally.</li>
<li>Responsible for documenting all phases per IPDP and quality compliance. Compile, maintain, review and interpret product development data.</li>
<li>Authors SOPs, Work Instructions, Batch Records, Product Specifications, Process Performance Qualification, Process Operational Qualification protocol plans and reports critical to Product development.</li>
<li>Supports Business managers to provide technical inputs to customers for early development programs and support Quality Assurance team with any non-conformance investigations as a subject matter expert.</li>
<li>Other duties and projects as assigned.</li>
</ul>
Who you are:
<ul>
<li>Bachelor’s degree in Textile Engineering, Biomedical Engineering, Materials Engineering, or related discipline.</li>
<li>Experience in technical writing and use of statistical tools, including Minitab.</li>
<li>Proficient with MS Office.</li>
<li>Interpersonal skills with proven ability to get along well with others and work in a team environment is a must.</li>
<li>Strong analytical, critical thinking, leadership, and problem-solving skill is needed to manage technical projects.</li>
</ul>
What we offer:
<ul>
<li>Annual Bonuses</li>
<li>401k (retirement savings) with excellent company match</li>
<li>Generous Paid Time Off</li>
<li>Health Insurance: Medical with Rx plan / Dental / Vision</li>
<li>Company Paid Life Insurance and Disability Plans</li>
</ul>
Why join us: 
We promote a collaborative, high energy, and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.

Product Development Engineer I

<h3>Job Description</h3>
Job Description
The Process Engineer III is a senior-level engineering professional responsible for leading high-impact process improvement initiatives, optimizing workflows, and implementing scalable, sustainable solutions across multiple functions within the organization. This role applies advanced technical knowledge, data analytics, systems-thinking, and cross-functional collaboration to drive operational excellence and efficiency while ensuring regulatory and quality compliance. As a subject matter expert in continuous improvement methodologies, automation integration, and process engineering best practices, the Process Engineer III also provides mentorship and technical leadership to junior team members.
Job Responsibilities:
<ul>
<li>Drive the identification and resolution of inefficiencies across laboratory and office workflows, ensuring all process improvements align with organizational goals and compliance standards.</li>
<li>Design, implement, and validate advanced process enhancements and automation strategies that prmote scalability, operational efficiency, and reproducibility.</li>
<li>Lead continuous improvement efforts by facilitating process mapping, root cause analyses, corrective action planning, and the development of robust control systems.</li>
<li>Leverage operational data, KPIs, and performance metrics to assess workflow effectiveness and identify opportunities for ongoing optimization in collaboration with cross-functional teams.</li>
<li>Develop and approve technical documentation, including SOPs, validation protocols, and technical reports, to support standardization and regulatory compliance.</li>
<li>Manage complex, cross-functional projects, ranging from automation rollouts to large-scale process validation, ensuring timely delivery of key milestones and results.</li>
<li>Utilize advanced analytical tools, modeling techniques, and simulation software to evaluate and enhance process performance.</li>
<li>Lead root cause investigations and implement corrective and preventive actions (CAPAs) to resolve process deviations and strengthen process controls.</li>
<li>Champion the integration of automation technologies, digital tools, and control systems that improve throughput, consistency, and data traceability.</li>
<li>Stay current on emerging technologies, trends, and best practices in process engineering, automation, and anatomic pathology operations to proactively drive innovation.</li>
<li>Oversee and contribute to validation activities for new or modified processes, systems, and equipment to ensure alignment with regulatory expectations and internal quality standards.</li>
<li>Serve as a strategic technical advisor and liaison across Lab Operations, Pathology, Research &amp; Development, IT, Quality, Regulatory and administrative teams to facilitate the successful implementation of process improvements.</li>
<li>Engage stakeholders at all levels to ensure that process changes address operational needs while meeting quality and compliance requirements.</li>
<li>Represent the Process Engineering function in internal technical reviews, vendor evaluations , and cross-functional workstreams.</li>
<li>Deliver clear, impactful presentations and technical communications to senior leadership, project teams, and external partners to support decision-making and foster alignment.</li>
<li>Perform other responsibilities and special assignments as directed.</li>
</ul>
Knowledge, Skills &amp; Abilities:
<ul>
<li>5â€“8 years of progressively responsible experience in process engineering, laboratory operations, biotechnology, or related technical disciplines.</li>
<li>Proven track record of leading end-to-end process improvement initiatives, integrating automation, and driving continuous improvement within highly regulated environments.</li>
<li>Deep understanding of Lean, Six Sigma, and other process optimization methodologies, with demonstrated success applying these tools to enhance efficiency and reduce variability.</li>
<li>Strong experience managing complex, cross-functional projects, including validation, system implementation and operational change management.</li>
<li>Proficient in data analysis and statistical tools such as Python, MATLAB, JMP, Minitab and Arena, with the ability to translate data into actionable insights.</li>
<li>Hands-on familiarity with automation platforms, digital workflow tools, and process control systems used in laboratory or biotech settings..</li>
<li>Working knowledge of regulatory and quality standards including CLIA, CAP, FDA, ISO 13485, with a clear understanding of how to align process improvements with compliance expectations.</li>
<li>Strong analytical and critical thinking skills with the ability to identify inefficiencies, perform root cause analysis, and implement scalable, sustainable solutions.</li>
<li>Effective communicator with the ability to write clear technical documentation and deliver impactful presentations to both technical and executive audiences</li>
<li>Demonstrated ability to mentor and support junior engineers or cross-functional teammates, fostering collaboration and technical growth.</li>
<li>Highly organized, detail-oriented, and capable of balancing multiple priorities in a fast-paced, evolving environment.</li>
<li>Comfortable working in laboratory, production, and office settings, with a willingness to engage directly in hands-on process assessments when needed.</li>
</ul>
Education, Certifications &amp; Licensures:
<ul>
<li>Bachelor's degree in Biomedical Engineering, Process Engineering, Industrial Engineering, or a related field required.</li>
<li>Master's degree in engineering, systems engineering, biotechnology, or a related discipline is preferred.</li>
<li>Lean Six Sigma Green Belt certification is preferred.</li>
<li>Additional certifications in process engineering, continuous improvement, or project management, such as PMP, ASQ-CQE are also desirable.</li>
</ul>
Other:
<ul>
<li>Combination of seated and standing work to complete the core functions of the role.</li>
<li>Adherence to company safety policy.</li>
<li>Ability to work onsite at the Company's Scottsdale, AZ headquarters approximately five (5) days a week.</li>
</ul>

<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
Job Title: Senior Principal Quality Engineering Leader – Medical Device R&amp;D
Duration: 12 Months
Location: Bellevue WA 98005
Role &amp; Responsibilities:
Provide Quality Engineering leadership for software and hardware product development teams.
Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation.
Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM, lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects.
Guide triage and remediation efforts.
Secondary/Backup Duties and Responsibilities:
• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
• Own the resolution and timely closure of CAPAs as they relate to the design control process.
• Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
• Support other areas of the Quality System and perform other tasks as defined by Management.
Required Qualifications, Education and Experience:
• Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
• Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non- embedded software.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
• Exceptional verbal and written communication skills and presentation skills.
• Exceptional attention to detail with the proven ability to wear many hats.
• Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
• Creative problem solver.
• Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Additional Qualifications:
• Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
• Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
• Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.
• 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities 
<h3>Company Description</h3>
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Sr. Principal Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
RIVANNA is seeking a Product Development Engineer to join our dynamic engineering team. You will work with a talented team of professionals as we strive to achieve our mission to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. As a Product Development Engineer, you will contribute to activities across the product lifecycle, from prototype development to clinical support. This hands-on multidisciplinary role involves close collaboration with the mechanical, manufacturing, and electrical engineering team on a wide range of product development tasks and projects. This job will be on-site in Charlottesville, VA; applicants must be local or willing to relocate to Charlottesville for this position.
 
Responsibilities
<ul>
<li>Product Development: Support the development and improvement of medical devices and manufacturing processes </li>
<li>Testing: Design and execute test methods to verify subsystem and system performance, analyze data, and document results in test reports</li>
<li>Prototyping &amp; Fabrication: Operate and maintain 3D printers and machine shop equipment (e.g., mill, lathe, drill press) to support prototype and fixture fabrication</li>
<li>Manufacturing: Assist with the assembly of electromechanical systems for engineering builds, internal testing, and clinical evaluation</li>
<li>Documentation: Create and update design control and design transfer documentation including work instructions, BOMs, test plans, and test reports</li>
<li>Field Service: Provide technical support for systems in the field, including remote troubleshooting and occasional travel to clinical sites</li>
<li>Cross-functional Collaboration: Work closely with engineering, production, and clinical teams to support product development and sustaining efforts</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline</li>
<li>1-3 years of relevant industry experience in product development or R&amp;D (medical device experience preferred)</li>
<li>Hands-on experience with hand tools, power tools, 3D printing, soldering, and test equipment</li>
<li>Experience with SolidWorks or similar CAD software preferred</li>
<li>Exposure to medical device regulations and quality systems including ISO 13485, FDA design controls (21 CFR), and risk management processes (ISO 14971).</li>
<li>Strong organizational, communication, and technical writing skills</li>
<li>Ability to work independently and on cross-functional teams in a fast-paced environment</li>
<li>Willingness to travel occasionally (=10%) for field service support</li>
<li>Applicants must be authorized to work in the United States without the need for current or future sponsorship. RIVANNA is unable to provide employment sponsorship for this position.</li>
</ul>
About Rivanna Medical, Inc.: RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures. RIVANNA's revolutionary platforms feature BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.
 
Employee Benefits at Rivanna Medical: Rivanna Medical offers a comprehensive benefits package, which includes health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.
 
Equal Employment Opportunity Statement: Rivanna Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.

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