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<h3>Job Description</h3>
Job Description
Position Title:&nbsp;ISE I- Lebanon, PA&nbsp;
Salary:&nbsp;$88,000-$90,000/yr
Other Forms of Compensation:
&nbsp;
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
JOB DUTIES AND RESPONSIBILITIES: • Respond expeditiously to calls from clinical departments, and/or customers to evaluate and rectify valid operator complaints and concerns. • May assist senior imaging specialists or supervisor with in-service educational training on the proper use and operator maintenance of equipment. • Repair, install, maintain, calibrate, and inspect a diverse range of therapeutic and diagnostic imaging devices and systems, including planned maintenance and electrical safety testing. Diagnose, correct, and repair system and equipment malfunctions. • Maintain an orderly and functional working environment, ensuring tools and test equipment are calibrated and are in good working order before use, and follow the 5S methodology. • Participate in assigned on-call services in accordance with contractual guidelines and/or departmental policies. • Flexibility to work augmented shifts based on the unit’s needs to meet with client’s contractual requirements. • Conduct incident investigation, inspect and test malfunctioning equipment to determine course of malfunction, following learned procedures and manual instructions, using specialized test and analysis instruments and manufacturer’s specifications. • Perform major repairs by replacing defective components, glassware and readjust components to manufacturer’s specifications using appropriate tools and measuring instruments. May require certification in order to complete repairs. • Utilizes specialized knowledge and training to perform system calibrations within area of expertise. (i.e.- Rad, RF, Mammo, Nuc Med, CT, MR, or Ultrasound) • Confers with supervisor, other Imaging Technicians, manufacturer’s representatives and equipment operators to resolve equipment related problems. • Research and initiate orders for repair parts, working with the supervisor and/or the Technical Resource Center; demonstrate ability to effectively find second-source parts. • Provide accurate and timely database management of the CMMS in accordance with our Quality Management System and related policies and procedures. • Schedule and oversee third-party service as necessary. • Individual will be expected to participate in huddles, meetings, seminars, training, workshops, and conferences as required. • Perform other duties as assigned that are intrinsic to the successful operation of the account and the company. QUALIFICATIONS: Education: Associates degree in biomedical equipment technology, electronic equipment technology, or military training preferred. An equivalent combination of education and experience may be substituted. Formal radiology training and/or certifications(s) preferred i.e., CBET, CRES, etc. Experience: Three (3) years of imaging and/or biomedical experience servicing clinical/patient care equipment in a hospital, clinic, or service environment to include manufacturer-related experience.
&nbsp;
Apply to Intelas today!
 Intelas is a member of Compass Group USA
 Click here to Learn More about the Compass Story
&nbsp;
Associates at Intelas are offered many fantastic benefits.&nbsp;
&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.
&nbsp;
Applications are accepted on an ongoing basis.
 Intelas maintains a drug-free workplace.
&nbsp;
Req ID: 1492489 Intelas &nbsp; ASHLEY VAVROCK &nbsp; [[req_classification]]

Imaging Service Engineer I

<h3>Job Description</h3>
Job Description
DEKA Research &amp; Development, located in Manchester, NH, is seeking a Senior Test Engineer to work in a dynamic medical device R&amp;D environment. This is a high visibility role with a&nbsp;direct impact on the success of our projects. It will be a great opportunity to work on some amazing projects that make a positive impact on the world. Do you want to make a difference with your work? At DEKA you can!
How you will make an impact as a Senior Test Engineer:
<ul>
<li>Writing test plans, test procedures&nbsp;and other activities involving performance, durability, and reliability assessments</li>
<li>Understand device design and core technologies in order to inform test method development</li>
<li>Determining test coverage for revisions to design</li>
<li>Creating and evaluating test fixtures needed for product design verification</li>
<li>Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTAs</li>
<li>Participating and contributing toward regulatory and agency submissions</li>
<li>Authoring Quality Plans, Test Summaries, and other documents</li>
</ul>
What you need to be successful Senior Test Engineer:
<ul>
<li>BS in Biomedical, Mechanical and/or&nbsp;Robotics/ Automation Engineering</li>
<li>3+ years' experience testing&nbsp;electro-mechanical devices (medical devices preferred)</li>
<li>Must have laboratory/ wet lab skills and experience</li>
<li>Must have fluid system handling experience</li>
<li>Leadership and/or mentoring experience&nbsp;</li>
<li>Knowledge and deep understanding of engineering fundamentals</li>
<li>Capability to create and clearly explain team objectives and write procedures for others to follow</li>
<li>Demonstrated problem solving ability and techniques</li>
<li>Ability to work as part of an interdisciplinary team</li>
<li>Self-motivated and able to self-prioritize</li>
<li>Must have excellent verbal and written communication skills</li>
</ul>
Preferred skills and experience:&nbsp;
<ul>
<li>Knowledge of FDA&nbsp;Quality System Regulations (QSRs) and/or ISO&nbsp;13485, and other medical device industry experience</li>
<li>Experience with&nbsp;research, development, and product testing</li>
<li>Experience writing procedures for others to follow</li>
<li>Experience with data and failure analysis</li>
<li>Broad measurement instrument knowledge</li>
</ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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QFUYMi5MTb

Senior Test Engineer

<h3>Job Description</h3>
Job Description
Are you a hands-on problem-solver passionate about improving manufacturing processes? We're seeking a dedicated Manufacturing Engineer II to join our team and drive continuous improvement in a medical device manufacturing environment. If you're a detail-oriented professional with a knack for data-driven solutions and a strong commitment to quality, we want to hear from you.
&nbsp;
About the Role
As a Manufacturing Engineer II, you'll be a critical part of our team, owning continuous improvement activities and providing daily support for our automated medical device coating processes. You will use data to measure and enhance Quality, On-Time Delivery, and Cost (QDC) indicators, ensuring our methods and technologies are continually improving and sustainable. This role requires a high level of organization, excellent documentation skills, and the ability to work effectively in a multidisciplinary team.
&nbsp;
Key Responsibilities
<ul>
<li>
Process Improvement: Lead the design, development, and implementation of new manufacturing processes and technologies to increase efficiency and improve product quality.
</li>
<li>
Documentation &amp; Validation: Create and maintain detailed documentation, including process routings and work instructions. You'll also lead process validation activities (IQ, OQ, PQ) and support Test Method Validation (TMV).
</li>
<li>
Continuous Improvement: Champion a culture of lean manufacturing. You will apply tools like DMAIC, A3, and SPC to solve
</li>
<li>
complex technical problems, reduce waste, and enhance productivity.
</li>
<li>
Collaboration: Partner with cross-functional teams, including Operations, Quality Assurance, and Supply Chain, to seamlessly integrate new products and processes.
</li>
<li>
Problem-Solving: Participate in root cause analysis for non-conforming materials and develop effective corrective and preventive actions (CAPA).
</li>
<li>
Mentorship: You may be required to supervise and manage the workload of an Engineering Technician.
</li>
</ul>
&nbsp;
Qualifications
<ul>
<li>
Education: Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field.
</li>
<li>
Experience: 3-6 years of hands-on professional experience in manufacturing and process development within the medical device industry (ISO 13485 or FDA regulated).
</li>
<li>
Technical Skills:
<ul>
<li>
Experience with Fanuc, ABB, or similar industrial/collaborative robots.
</li>
<li>
Proficiency in CAD software (SolidWorks, AutoCAD, or similar), including GD&amp;T tolerancing and creating assemblies.
</li>
<li>
Experience with statistical analysis software (Minitab, JMP, or similar).
</li>
<li>
Proven experience with root cause analysis and problem-solving methodologies (e.g., 5 Whys, Fishbone Diagram).
</li>
<li>
Lean Six Sigma Green Belt certification is required, and a Black Belt is a plus.
</li>
</ul>
</li>
<li>
Personal Skills: You are a highly organized, self-motivated individual with a positive attitude. You have excellent communication skills and a "can-do" mindset.
</li>
</ul>
&nbsp;
Why Join Us?
We're a team that believes in Making Quality Personal. We're relentlessly committed to improvement and work together to deliver results. We are dedicated to creating a supportive environment where you can grow and thrive. Our culture is built on teamwork, accountability, and the shared goal of making a difference in the medical device industry.
Ready to apply your skills to a challenging and rewarding role?
Company DescriptionPrecision Coating, an Integer company, partners with global MedTech customers to deliver innovative products and services to enhance the surface functionality of their patient critical products. The company operates four facilities: two in Massachusetts, two in Rhode Island, and one in Costa Rica, and serves customers worldwide, offering seamless supply chain support. Additional information about Precision Coating is available at <a href="http://www.precisioncoating.com" target="_blank">www.precisioncoating.com</a>. Precision Coating is an Equal Opportunity Employer. 
<h3>Company Description</h3>
Precision Coating, an Integer company, partners with global MedTech customers to deliver innovative products and services to enhance the surface functionality of their patient critical products. The company operates four facilities: two in Massachusetts, two in Rhode Island, and one in Costa Rica, and serves customers worldwide, offering seamless supply chain support. Additional information about Precision Coating is available at <a href="http://www.precisioncoating.com" target="_blank">www.precisioncoating.com</a>. \r\n\r\nPrecision Coating is an Equal Opportunity Employer.

Manufacturing Engineer II

<h3>Job Description</h3>
Job DescriptionDescription:
RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.
 
OVERVIEW:
The Manufacturing Engineer II will play a vital role in supporting and leading the sustaining efforts aimed at continuous improvement and maintaining robust manufacturing processes related to the Light Adjustable Lens and Insertion device manufacturing. As a vital member of the Manufacturing Engineering team, this individual will closely collaborate with Design Engineering and Quality Control/Assurance departments to ensure production line sustainability, compliance with regulations, and quality systems requirements. The Manufacturing Engineer II will be responsible for supporting lean manufacturing methodology and implementing the culture of continuous improvement to improve overall safety, quality, on-time delivery, and productivity of our LAL and Insertion device manufacturing and processes. This individual will also support the engineering team and other departments in identifying and resolving manufacturing processes and production issues.
Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
<ul>
<li>Lead effort in support of continuous improvement initiatives aimed at enhancing production efficiency, ensuring business continuity, and maintaining regulatory compliance.</li>
<li>Provide troubleshooting expertise for equipment-related issues and offer technical support to operators and technicians as required.</li>
<li>Establish and execute validation strategies (IQ/OQ/PQ) for new processes, and equipment in compliance with ISO 13485 and FDA regulations.</li>
<li>Initiate documents such as drawings, work instructions, and reports ensuring proper routing through the quality management system.</li>
<li>Perform training necessary for the implementation of processes/tooling changes as necessary.</li>
<li>Set up, operate, and maintain various manufacturing equipment and tools.</li>
<li>Perform diagnostics, troubleshoot, and repair complex electrical, mechanical, network and software issues.</li>
<li>Participate in root cause analysis and implement corrective actions for manufacturing issues.</li>
<li>Ability to stay on tasks with minimal supervision and minimal direction.</li>
</ul>
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
<ul>
<li>Demonstrates a hands-on approach to problem solving, ensuring prompt task closure.</li>
<li>Familiarity with SolidWorks PDM software (desired).</li>
<li>Proficient in conducting training sessions and initiating engineering change requests.</li>
<li>Prior experience working in a cleanroom environment/ or medical device manufacturing is highly preferred.</li>
<li>Professional, responsible, energetic, and accountable.</li>
<li>Strong interpersonal skills – the ability to communicate effectively at multiple organizational levels including technicians, Engineering, Chemistry, and Production operators.</li>
<li>Clear communicator – understands how to distill information to have substantive discussions with the right audience.</li>
<li>Strong Organizational skills – the ability to balance and prioritize multiple studies, and manufacturing builds.</li>
<li>Continued appetite to learn about our technology, its performance characteristics, and its manufacturing process – our process and our technology are unique!</li>
<li>Self-motivated, proactive, and able to work effectively under minimal supervision.</li>
</ul>
SUPERVISORY RESPONSIBILITIES:
<ul>
<li>None</li>
</ul>
EDUCATION, EXPERIENCE, and TRAINING:
<ul>
<li>Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 3 years of technical experience.</li>
<li>Master’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 2 years of technical experience.</li>
<li>Continuous improvement experience.</li>
<li>Familiarity with regulatory standards (ISO 13485).</li>
<li>Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus. </li>
</ul>
CERTIFICATES, LICENSES, REGISTRATIONS:
<ul>
<li>None</li>
</ul>
COMPUTER SKILLS:
<ul>
<li>Microsoft Word; Microsoft Excel;</li>
<li>MiniTab</li>
<li>CAD (SolidWorks or PRO/E proficiency preferred) </li>
<li>Project Management System (SmartSheet preferred)</li>
</ul>
Notice to Staffing Agencies and Search Firms:
RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.

<h3>Job Description</h3>
Job DescriptionDescription:
Job purpose
 
The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&amp;D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
 
Duties and responsibilities
 
<ul>
<li>Plan and execute process optimization, equipment qualification, and process validation or process qualification projects.</li>
<li>Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.</li>
<li>Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports.</li>
<li>Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.</li>
<li>Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan.</li>
<li>Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team.</li>
<li>Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards. </li>
<li>Assess processes, take measurements, and interpret data.</li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Comply with FDA and AATB tissue banking standards.</li>
<li>Other duties as assigned.</li>
</ul>
 
Requirements:
Qualifications
 
Qualifications include:
<ul>
<li>BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. </li>
<li>Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred.</li>
<li>Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred.</li>
<li>Proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment).</li>
<li>Strong work ethics.</li>
</ul>
 
Working conditions
 
Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. 
 
Physical requirements
 
The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
No direct reports

Process Engineer I

<h3>Job Description</h3>
Job Description
GenomOncology, a precision medicine software company, provides the healthcare community with data-driven insights to improve cancer care. Their cutting-edge solutions empower their clients' precision oncology workflows by transforming data into actionable treatment options and strategic insights, ultimately driving measurable results. With their expertise and innovative solutions, they aim to help revolutionize the field of oncology, empowering healthcare professionals to make data-driven decisions and elevate the standard of cancer care. They are currently seeking an Application Engineer to join their team and help to advance product development, client success, and solutions delivery. 
 
The Application Engineer position is focused on ensuring customer service and satisfaction with the use of GO applications and solutions. This role serves as a liaison between the Client and the GO Product Development/Development Operations teams. Specific activities for this position include facilitating client discussions and requirement gathering; designing, configuring and testing GO applications and solutions; collaborating with the GO Client Service, Product Development and Development Operations teams for application updates, configurations, deployments and troubleshooting; and contributing to the GO knowledge management repository in the form of documentation and process definition.
 
ESSENTIAL RESPONSIBILITIES:
<ul>
<li>Serve as liaison between Client Service / Product Development / Development Operations and GO clients.</li>
<li>Participate and/or facilitate client meetings to gather design requirements, answer questions on solution design and functionality, and report status on GO tasks and activities.</li>
<li>Collaborate with Account/Project Managers in the development of project plans, time estimates and general planning activities for client delivery.</li>
<li>Gather application configuration, feature/functionality specification and data requirements from client and document as JIRA design tickets.</li>
<li>Create UI, Report and Data Output mockups and wireframes to illustrate the desired functionality and output within the GO tool(s).</li>
<li>Collaborate with Product Development to ensure design tickets are fully understood and ready for development.</li>
<li>Participate in application feature and design reviews with the Product Development,</li>
<li>Application Engineering and Innovation teams.</li>
<li>Write validation test(s) in YAML and gherkin to test and validate the feature/functionality/configuration the design ticket specifies is met.</li>
<li>Execute both manual and automated testing of GO tools to ensure the design specifications are met.</li>
<li>Create JIRA tickets to specify deployment requirements for Application, Content and/or annotations, therapy and trial updates that are ready for deployment.</li>
<li>Support Development Operations (and/or Perform) in the deployment of Application,Content and/or Pipeline Rules updates to GO Internal, GO-hosted, and Client-hosted environments.</li>
<li>Respond to Client support requests and questions.</li>
<li>Perform application troubleshooting and/or coordinate troubleshooting activities amongst the Product Development / Development Operations teams. May include running troubleshooting scripts when necessary.</li>
</ul>
 
ANCILARY RESPONSIBILITIES:
<ul>
<li>Maintain individual tasks and activities list within Jira</li>
<li>Identify new feature/solution requests from clients to bring to the GO Innovation and Product Development teams for consideration.</li>
<li>Create application training guides and conduct training sessions with clients</li>
<li>Update Client Trackers to maintain current versioning of GO Tools, Datasets and Configurations.</li>
<li>Contribute to and maintain GO Knowledge Management on application and tool functionality and GO processes.</li>
<li>Attend and engage in Team and All Company meetings.</li>
</ul>
 
REQUIREMENTS:
<ul>
<li>Strong critical-thinking and analytical skills</li>
<li>Superior service orientation</li>
<li>Outstanding interpersonal and communication skills, both oral and written</li>
<li>Strong ability to translate client requirements into technical requirements for accurate development of application customization/enhancement</li>
<li>Understanding of the Standard Software Development Life Cycle process and/or experience with Jira is a plus.</li>
<li>Strong working knowledge of Google Workspace and MS Office Suite</li>
<li>Self-motivated and ability to work autonomously and as a collaborative team member </li>
<li>Strong multi-tasking and prioritizing capabilities and ability to be flexible and adaptable in a fast-paced work environment</li>
<li>High attention to detail</li>
<li>Continuous improvement oriented and ability to learn new technologies and subjects quickly</li>
</ul>
 
EDUCATION:
<ul>
<li>Bachelor’s Degree: Engineering (Mechanical, Biomedical, Software) preferred</li>
<li>1-3+ years application design or related experience; experience in solution design, quality assurance, technical support and client service within a Software Development</li>
<li>Life Cycle (SDLC) process is desired Previous experience in biomedical field is desired</li>
</ul>

Application Engineer

<h3>Job Description</h3>
Job DescriptionSenior Product Development Engineer COMPANY OVERVIEW: Sage Product Development, Inc. provides fast, efficient and creative product development services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure. We solve client companies technical challenges and meet their product development needs in a timely, efficient and highly personalized manner. We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their product development engineering abilities, and build their network within the industry. GENERAL SUMMARY: 
<ul>
<li>Develop medical devices from concept through market introduction on a contract basis for client companies.</li>
<li>Meet or exceed customer expectations.</li>
</ul>
 ESSENTIAL JOB FUNCTIONS (all as required by client companies): 
<ul>
<li>Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the projects client company.</li>
<li>Generate project timing and expense estimates and prepare project proposals for client companies.</li>
<li>Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.</li>
<li>Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.</li>
<li>Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.</li>
<li>Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.</li>
<li>Investigate and evaluate existing technology for application to projects.</li>
<li>Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.</li>
<li>Produce prototype devices for testing and evaluation. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.</li>
<li>Conduct bench and/or animal feasibility studies.</li>
<li>Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.</li>
<li>Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.</li>
<li>Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.</li>
<li>Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations.</li>
<li>Maintain detailed essential product and process documentation throughout all phases of research and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete and well organized.</li>
<li>Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.</li>
<li>Ensure that all work satisfies the requirements of client companies Quality Systems, with particular emphasis on Design Control.</li>
<li>Conduct and document Design Reviews.</li>
<li>Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.</li>
<li>Date, sign and have witnessed all documents that may establish inventorship dates.</li>
<li>Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).</li>
</ul>
OTHER DUTIES AND RESPONSIBILITIES: 
<ul>
<li>Any other duties as assigned.</li>
</ul>
REQUIRED COMPETENCIES: Customer Focus 
<ul>
<li>Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers needs and take appropriate action. Follow through on customers inquiries in a professional and timely manner.</li>
</ul>
Management of Resources 
<ul>
<li>Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.</li>
</ul>
Communication Skills 
<ul>
<li>Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.</li>
</ul>
PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES: 
<ul>
<li>Bachelor's degree in Mechanical, Biomedical or Electromechanical Engineering is required. Masters degree in engineering, management or business is a plus.</li>
<li>Project management experience is required.</li>
<li>Some prior medical device product design and development experience is required.</li>
<li>Demonstrated ability to bring products from concept to market.</li>
<li>Ability to interact with client companies in a professional manner.</li>
<li>SolidWorks 3D CAD proficiency is required.</li>
<li>Knowledge of probability and statistics.</li>
<li>Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.</li>
<li>Familiarity with FDA QSR and ISO 13,485 medical device regulations.</li>
<li>Depth of knowledge in one or more clinical areas.</li>
<li>Depth of knowledge in one or more medical device product areas.</li>
<li>Depth of knowledge in one or more technical areas, for example finite element analysis.</li>
</ul>
BONUS: 
<ul>
<li>Experience in development of catheter-based devices.</li>
<li>Experience in electrical and/or electromechanical medical device design and development.</li>
</ul>
SUPERVISORY RESPONSIBILITY: 
<ul>
<li>May direct the work of other people, and may have direct reports.</li>
</ul>
REPORTS TO: Engineering Manager WORKING CONDITIONS/PHYSICAL DEMANDS: 
<ul>
<li>Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment.</li>
<li>The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.</li>
<li>External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.</li>
</ul>

Senior Product Development Engineer

<h3>Job Description</h3>
Job DescriptionBridgeMed Solutions, Inc is seeking a Manufacturing Engineer. Training will be provided. &nbsp; &nbsp; Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives. &nbsp; Job Title: Manufacturing Engineer Experience: +3 years of experience in Engineering, experience in medical device is a plus.&nbsp; Location: Local candidates only (must live in Orange County) Job Type: Full Time, 100% In-House Salary: $33-$43 DOE (Non-Exempt) Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage,&nbsp; Principal Duties and Responsibilities 
<ul>
<li>Experience in medical device manufacturing. - Suture Experience is a PLUS!</li>
<li>Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).</li>
<li>Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.</li>
<li>Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.</li>
<li>Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.</li>
<li>Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.</li>
<li>Project and client management is a must&nbsp;</li>
</ul>
Skills and Qualifications 
<ul>
<li>Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).</li>
<li>Minimum of 3 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.</li>
<li>Proven experience in project management and cross-functional team collaboration.</li>
<li>Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.</li>
<li>Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.</li>
<li>Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab) is a plus.</li>
<li>Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.</li>
</ul>

Engineer (Mechanical - Medical Device)

<h3>Job Description</h3>
Job Description
The Manufacturing Engineer Contractor will support the design, validation, implementation, and optimization of manufacturing processes and equipment for ophthalmic medical devices used in cataract and vitreoretinal surgeries. This role is hands-on and highly technical, with a strong focus on equipment validation, statistical process control, and continuous improvement in a regulated medical device manufacturing environment.
Key Responsibilities
<ul>
<li> Lead, execute, document, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated production equipment and processes. </li>
<li> Design, develop, validate, and implement manufacturing processes for ophthalmic medical devices. </li>
<li> Provide hands-on engineering support for manufacturing equipment before, during, and after release to production. </li>
<li> Apply Lean Manufacturing and Six Sigma methodologies to optimize production processes. </li>
<li> Implement Continuous Monitoring using Statistical Process Control (SPC) to maintain equipment and processes in a validated state. </li>
<li> Perform continuous statistical analysis of Critical Quality Attributes (CQAs) and process indicators to ensure compliance with product specifications (CpK / process capability). </li>
<li> Design fixtures and create technical drawings using CAD software (e.g., SolidWorks) to support daily production operations. </li>
<li> Develop and maintain standard work instructions and procedures to ensure robust and high-quality manufacturing processes. </li>
<li> Promote cross-functional collaboration through clear communication and effective coordination with all departments. </li>
</ul>
Required Skills &amp; Competencies
<ul>
<li> Medical Device Validation (IQ, OQ, PQ) </li>
<li> Statistical Process Control (SPC) </li>
<li> Statistical Analysis techniques including: </li>
<ul>
<li> DOE </li>
<li> ANOVA </li>
<li> Gage R&amp;R </li>
<li> T-Test </li>
<li> Tolerance Interval Analysis </li>
<li> Control Charts </li>
<li> Process Capability (CpK) </li>
</ul>
<li> Proficiency with statistical software (Minitab) </li>
<li> CAD design experience (SolidWorks or equivalent) </li>
<li> Strong technical writing skills </li>
<li> Effective public speaking and communication skills </li>
</ul>
Preferred Skills
<ul>
<li> Manufacturing simulation software experience (FlexSim – preferred, not required) </li>
</ul>
Requirements
Education &amp; Experience
<ul>
<li>Required:</li>
<ul>
<li> Bachelor’s Degree in Engineering or Biomedical Engineering </li>
<li> Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment </li>
</ul>
<li>Preferred:</li>
<ul>
<li> Master’s Degree in Engineering or Biomedical Engineering</li>
</ul>
</ul>
Benefits
<ul>
<li>12-MONTH CONTRACT </li>
</ul>

Manufacturing Engineer-Medical Device

<h3>Job Description</h3>
Job Description
Position Title:&nbsp;ISE II- NY, NY&nbsp;
Salary:&nbsp;$90,000- $120,000/yr
Other Forms of Compensation:
&nbsp;
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
&nbsp;JOB DUTIES AND RESPONSIBILITIES:&nbsp; • Respond expeditiously to calls from clinical departments, and/or customers to evaluate and rectify valid operator complaints and concerns.&nbsp; • May assist senior imaging specialists or supervisor with in-service educational training on the proper use and operator maintenance of equipment.&nbsp; • Handle difficult customer situations&nbsp; • Repair, install, maintain, calibrate, and inspect a diverse range of therapeutic and diagnostic imaging devices and systems, including planned maintenance and electrical safety testing. Diagnose, correct, and repair system and equipment malfunctions.&nbsp; • Maintain an orderly and functional working environment, ensuring tools and test equipment are calibrated and are in good working order before use, and follow the 5S methodology.&nbsp; • Participate in assigned on-call services in accordance with contractual guidelines and/or departmental policies.&nbsp; • Flexibility to work augmented shifts based on the unit’s needs to meet with client’s contractual requirements.&nbsp; • Conduct incident investigation, inspect and test malfunctioning equipment to determine course of malfunction, following learned procedures and manual instructions, using specialized test and analysis instruments and manufacturer’s specifications.&nbsp; • Perform major repairs by replacing defective components, glassware and readjust components to manufacturer’s specifications using appropriate tools and measuring instruments. May require certification in order to complete repairs.&nbsp; • Utilizes specialized knowledge and training to perform system calibrations within area of expertise. (i.e.- Rad, RF, Mammo, Nuc Med, Linear Acc, PET-CT, CT, MR, or Ultrasound)&nbsp; • Confers with supervisor, other Imaging Technicians, manufacturer’s representatives and equipment operators to resolve equipment related problems.&nbsp; • Mentors other ISE’s for equipment servicing in modalities of expertise.&nbsp; • Research and initiate orders for repair parts, working with the supervisor and/or the Technical Resource Center; demonstrate ability to effectively find second-source parts.&nbsp; • Provide accurate and timely database management of the CMMS in accordance with our Quality Management System and related policies and procedures.&nbsp; • Schedule and oversee third-party service as necessary.&nbsp; • Individual will be expected to participate in huddles, meetings, seminars, training, workshops, and conferences as required.&nbsp; • Perform other duties as assigned.&nbsp; QUALIFICATIONS:&nbsp; Education: Bachelors degree in biomedical equipment technology, electronic equipment technology, or military training preferred. An equivalent combination of education and experience may be substituted. Formal radiology training and/or certifications(s) preferred i.e., CBET, CRES, etc.&nbsp; Experience: Five (5) years servicing Diagnostic Imaging equipment preferred.
&nbsp;
Apply to Intelas today!
 Intelas is a member of Compass Group USA
 Click here to Learn More about the Compass Story
&nbsp;
Associates at Intelas are offered many fantastic benefits.&nbsp;
&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.
&nbsp;
Applications are accepted on an ongoing basis.
 Intelas maintains a drug-free workplace.
&nbsp;
Req ID: 1469491 Intelas &nbsp; ASHLEY VAVROCK &nbsp; [[req_classification]]

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