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<h3>Job Description</h3>
Job Description
About DeepSight Technology 
DeepSight Technology is a leading innovator in medical device technology, specializing in advanced ultrasound solutions like enhanced needle guidance with NeedleVue™, high-resolution imaging from the tip of a needle with OnPoint™ Imaging, and superior diagnostic capability with the EchoLux™ Ultrasound system. Our mission is to revolutionize patient care through state-of-the-art systems, oIering unprecedented precision and accuracy for healthcare providers. 
Job Summary 
The Instrument Engineer will lead the design, prototyping, and optimization of DeepSight's interventional instruments. This role takes concepts from ideation to prototype, ensuring seamless integration into clinical applications. The ideal candidate excels in medical device development, rapid prototyping, and regulatory compliance, working cross-functionally with R&amp;D, clinical, and manufacturing teams. 
Key Responsibilities 
<ul>
<li> Develop interventional devices such as catheters, guidewires, venous access tools, biopsy instruments, and therapy delivery systems. </li>
<li> Design, prototype, and test instruments, fixtures, and assemblies. </li>
<li> Build and iterate proof-of-concept devices for pre-clinical testing. </li>
<li> Initiate and maintain the Device Master Record through development, including:</li>
</ul>
<ul>
<li>Drawings, specifications, and BOMs </li>
<li>Process instructions, test methods, and specifications </li>
<li>Fixtures, tooling, and material selection </li>
</ul>
<ul>
<li> Identify and collaborate with contract manufacturers and suppliers for sub-assemblies and production. </li>
<li> Work with clinical experts to ensure procedural requirements and constraints are incorporated into the instrument design. </li>
<li> Apply expertise in Advanced Manufacturing Techniques: </li>
</ul>
<ul>
<li>Lamination, extrusions, coiling, and braiding </li>
<li>Steering and bending sections </li>
<li>Bonding, adhesion technologies, and techniques </li>
<li>Laser cutting, welding of fine structures, EDM, and water jet machining </li>
</ul>
<ul>
<li> Ensure compliance with ISO 13485, ISO 60601, ASTM, and other relevant standards. </li>
<li> Develop and refine work instructions for designs, ensuring eIective communication with technicians. </li>
</ul>
Qualifications
<ul>
<li> B.S. or M.S. in Mechanical or Biomedical Engineering or related field. </li>
<li> 10+ years of experience in instrument engineering or medical device development. </li>
<li> Proficiency in CAD for device design and documentation. </li>
<li> Experience with medical device fabrication techniques (lamination, laser cutting, bonding, etc.). </li>
<li> Knowledge of interventional devices (catheters, guidewires, biopsy tools, etc.). </li>
<li> Familiarity with regulatory standards (ISO 13485, ISO 60601, ASTM). </li>
<li> Strong hands-on prototyping skills and ability to rapidly iterate designs. </li>
<li> Experience collaborating with contract manufacturers and suppliers. </li>
<li> Excellent problem-solving and cross-functional collaboration skills. </li>
</ul>
Why Join DeepSight? 
At DeepSight Technology, you'll be part of a team that's pushing the boundaries of ultrasound imaging and medical device innovation. This is an opportunity to develop groundbreaking instrumentation, collaborate with top engineers and clinicians, and impact the future of healthcare.
 Job Posted by ApplicantPro

Instrument Engineer

<h3>Job Description</h3>
Are you an experienced Software Quality Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Software Quality Engineer to work at their company in Waltham, MA.
 
Position Summary: The OPAL Mapping System is a 3D mapping and navigation system and is an effective diagnostic tool for cardiac electrophysiology (EP) procedures. It provides real-time visualisation of intracardiac catheters and a display of 3D cardiac maps in selected formats in minimally invasive procedures to assist the physician in identifying the origin of the arrhythmia within the heart chamber. As a physician probes the heart with a catheter, the system generates an accurate anatomical model of the chamber. High-performance rendering and algorithmic techniques are vital to creating a stunning view and providing the physician with instant feedback. The software test engineer will join a highly effective product quality team in Waltham, working side-by-side with developers in an Agile environment, developing test cases for a wide range of software components, including user interface, algorithms and back-end data handling. The position will also include writing or updating test cases, manual execution of tests, and interacting with a variety of electronic equipment in the lab. Besides manual testing, the candidate would be involved in working in test automation, which requires coding skills in Python or other programming languages in a Linux environment.
 
Primary Duties &amp; Responsibilities:
<ul>
<li>Design, develop and execute test cases to ensure the quality of the product by proving system functionality, verifying business and user requirements are met in the Electrophysiology domain area.</li>
<li>Manual execution of tests or executing automated test scripts.</li>
<li>Create and execute automated test scripts.</li>
<li>Debug and fix issues on the automated test scripts within its verification points</li>
<li>Debug and fix issues that may be related to the automation framework.</li>
<li>Execute automation runs to test JIRA items and coordinate with multiple scrum teams</li>
<li>Design and develop new websites to support test automation</li>
<li>Ensure that tests have been conducted in accordance with written procedures.</li>
<li>Document test results and write test reports.</li>
<li>Diagnose problems and report bugs and enhancements in a bug tracking system.</li>
<li>Share knowledge and demonstrate product areas to other team members on an ad hoc basis.</li>
<li>Assist in determining test methodology, test strategy and test data setup.</li>
<li>Participate in daily scrum meetings, product review meetings, bug triage meetings etc.</li>
<li>Work closely with the software development team, the hardware engineering team, field support team, and other cross-functional teams.</li>
<li>Build Quality into all aspects of their work by maintaining compliance to all quality requirements.</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelor's degree along with 3+ years of software test engineer or related experience or 1+ years with</li>
<li>A master's degree or advanced degree, preferably BS/MS in Computer Science, Biomedical</li>
<li>Engineering, or equivalent. Completion and degree must be clearly stated on the resume.</li>
<li>Prior programming experience in Python is required.</li>
<li>Experience with test automation tools such as Selenium and Squish.</li>
<li>Prior experience with source code management tools such as Git and BitBucket.</li>
<li>Experience working in an Agile Scrum development environment.</li>
<li>Strong written and verbal communication skills.</li>
<li>Strong analytical and problem-solving skills.</li>
</ul>
 
Preferred:
<ul>
<li>C++ is great to have</li>
<li>A strong product quality and testing experience, preferably in the medical device domain.</li>
<li>Working knowledge of test automation under a Linux/Unix environment.</li>
<li>A natural attention to detail and a penchant for organising and documenting.</li>
<li>A good learner who can master complex software and quickly adapt to new tools and technologies.</li>
<li>Experience working in an Agile Scrum development environment.</li>
<li>Ability to think logically and analytically in a problem-solving environment.</li>
<li>Ability to work independently as well as work collaboratively as part of a team.</li>
<li>Follow company policy regarding ISO and FDA documentation and compliance for medical devices.</li>
</ul>

Software Quality Engineer

<h3>Job Description</h3>
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 two years experience with various imaging equipment manufacturers or other appropriate related experience</li>
<li>Minimum of two 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, ultrasound, 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>
 
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

Imaging Service Engineer I

<h3>Job Description</h3>
*Note: this position is only on-site in Irvine, CA*
 
 
About the Job
We are seeking a highly skilled Principal Systems Engineer to join our fast-paced, mission-driven medical device team. The ideal candidate will have a strong foundation in electrical, biomedical or systems engineering with demonstrated experience in multidisciplinary medical device system development. This role is critical to ensuring seamless integration across complex product architectures, guiding teams through the full product lifecycle—from concept through FDA submission and commercialization.
The Principal Systems Engineer will lead systems-level design and integration activities, translating clinical and user needs into engineering requirements and ensuring that design outputs meet performance and regulatory expectations. This individual will thrive in a matrixed environment, working cross-functionally with electrical, mechanical, software, and clinical teams to deliver safe, reliable, and innovative medical technologies.
 
Key Responsibilities
<ul>
<li>Lead systems engineering activities from concept through verification, validation, and regulatory submission.</li>
<li>Translate clinical and user needs into clear, testable system and subsystem requirements.</li>
<li>Develop and maintain system architecture, block diagrams, and interface control documents.</li>
<li>Oversee risk management, FMEA, and system-level hazard analysis in accordance with ISO 14971.</li>
<li>Drive design reviews, integration testing, and system verification/validation activities.</li>
<li>Collaborate closely with electrical, mechanical, and software engineering teams to ensure cohesive system performance and design integrity.</li>
<li>Serve as the primary technical liaison across functions, facilitating decision-making and resolving cross-disciplinary challenges.</li>
<li>Contribute to regulatory documentation and support FDA submissions, preferably for invasive medical devices.</li>
<li>Mentor junior engineers and foster a collaborative, high-performing technical culture.</li>
<li>Ensure compliance with design control processes, quality standards, and applicable regulatory requirements (e.g., IEC 60601, ISO 13485).</li>
</ul>
 
Qualifications
<ul>
<li>Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering or Systems Engineering, or related technical discipline.</li>
<li>15+ years of experience in systems engineering within the medical device or similarly regulated industry.</li>
<li>Proven experience leading cross-functional teams through the development of complex electromechanical systems.</li>
<li>Prior experience with FDA submission and design control documentation; invasive device experience strongly preferred.</li>
<li>Hands-on understanding of electrical systems, embedded software, and mechanical integration principles.</li>
<li>Strong analytical, problem-solving, and communication skills.</li>
<li>Demonstrated ability to thrive in a matrixed organization, coordinating efforts across engineering, quality, clinical, and regulatory functions.</li>
<li>Familiarity with relevant regulatory standards.</li>
<li>Excellent organization and documentation skills, with a detail-oriented and execution-focused mindset.</li>
</ul>
 
Preferred Qualifications
<ul>
<li>Advanced degree (M.S. or Ph.D.) in a related field.</li>
<li>Experience with model-based systems engineering (MBSE) tools and methods.</li>
<li>Experience in startups or fast-paced product development environments.</li>
<li>Experience with medical systems.</li>
</ul>

Principal Systems Engineer

<h3>Job Description</h3>
We’re partnering with a fast-growing global medical device company developing innovative wound-care technologies that improve patient outcomes and manufacturing efficiency. The team is seeking a Product &amp; Process Development Engineer who’s passionate about product innovation, process optimization, and advancing healthcare technology.
 
In this role, you’ll:
<ul>
<li>Drive design, development, and testing of new and existing wound-care products.</li>
<li>Support sustaining engineering and implement improvements across R&amp;D and manufacturing.</li>
<li>Develop fixtures, documentation, and validation plans to ensure compliance with FDA 21 CFR 820 and ISO 13485.</li>
<li>Troubleshoot production issues and collaborate cross-functionally to ensure smooth launches.</li>
</ul>
 
Background requirements: 
<ul>
<li>A Bachelor’s or higher degree in Mechanical, Biomedical, or related Engineering field.</li>
<li>2+ years of experience in the medical device or life sciences industry.</li>
<li>Proficiency in CAD software (SolidWorks preferred).</li>
<li>Familiarity with quality system regulations and validation testing.</li>
</ul>
 
If you’re ready to contribute to cutting-edge wound-care innovations and thrive in a collaborative, hands-on environment — we’d love to connect.

Product Development Engineer

<h3>Job Description</h3>
Company Overview:&nbsp;
Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.&nbsp;
We are currently seeking a talented Senior Systems Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management and risk management, along with hands-on electrical engineering skills, including electrical component analysis with review of datasheet, board bring-up, troubleshooting, and rework/soldering. This is a multidisciplinary role requiring understanding of the design controls process for medical device industry.&nbsp;
Responsibilities:&nbsp;
<ul>
<li>Translates voice of customer into user needs for medical device products.&nbsp;&nbsp;</li>
<li>Develops system and subsystem requirements.&nbsp;</li>
<li>Works closely with multi-disciplinary engineering team, including hardware and software engineers, to design, integrate, and verify embedded systems.&nbsp;</li>
<li>Participates in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.&nbsp;</li>
<li>Participates in safety and cybersecurity risk analysis activities.&nbsp;</li>
<li>Ensures the requirements may be verified in compliance with design controls and other QMS SOPs.&nbsp;</li>
<li>Coordinates system verification and validation activities, including integration of mechanical, electrical, and software components.&nbsp;</li>
<li>Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.&nbsp;</li>
<li>Reviews and develops technical documentation to ensure the planned activities match the system and subsystem verification and validation approach.&nbsp;</li>
<li>Leads requirements verification and validation activities by actively engaging in the technical work, supervising V&amp;V engineers as needed.&nbsp;</li>
<li>Leads and reviews reports from external testing including 60601, biocompatibility, FCC, usability, and cybersecurity&nbsp;</li>
<li>Participates in Design Reviews and leads technical reviews&nbsp;</li>
<li>Coordinates and presents technical data, analyses, and status at reviews (internal and external).&nbsp;</li>
<li>Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.&nbsp;</li>
<li>Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with DHS senior leadership&nbsp;</li>
<li>Stay current with industry trends, emerging threats, and best practices in medical devices to continuously improve our services and maintain our competitive edge.&nbsp;</li>
<li>Performs other tasks as required.&nbsp;</li>
</ul>
Qualifications:&nbsp;
<ul>
<li>Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Systems Engineering, or related field. Master’s degree preferred.&nbsp;</li>
<li>2 to 5 years of experience in systems engineering, with a focus on medical devices.&nbsp;</li>
<li>Strong knowledge of IEC 62304, IEC 60601, ISO 13485, ISO 14971, 21 CFR 820.30, ANSI/AAMI SW96, FDA Guidance for Cybersecurity in Medical Devices and other relevant medical device regulations and standards.&nbsp;</li>
<li>Demonstrated experience in conducting risk assessments and developing risk mitigation strategies for complex systems. Knowledge of security risk management activities preferred.&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills and the ability to work independently or as part of a team.&nbsp;</li>
<li>Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.&nbsp;</li>
</ul>
What We Offer:&nbsp;
<ul>
<li>Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.&nbsp;</li>
<li>Opportunity to work with cutting-edge technology in the medical device industry.&nbsp;</li>
<li>A supportive, collaborative work environment that fosters professional growth and development.&nbsp;</li>
<li>The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.&nbsp;</li>
</ul>

Senior Systems Engineer

<h3>Job Description</h3>
Location: Woburn, MA
 
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
 
Research &amp; development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. 
 
Responsibilities
<ul>
<li>Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams</li>
<li>Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations</li>
<li>Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess’ Quality System.</li>
<li>Supervise and mentor junior engineer(s) and technicians, including a direct report</li>
<li>Collaborate closely with cross-functional teams to support product development and manufacturing activities.</li>
</ul>
 
Qualifications
<ul>
<li>BS in Mechanical Engineering, Biomedical Engineering, or a related discipline</li>
<li>5 – 7 years of relevant direct R&amp;D experience within the medical device or biopharmaceutical industries; experience working on combination products is highly desirable</li>
<li>Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus</li>
<li>Excellent time and project management skills and proven ability to meet goals and deadlines</li>
<li>Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams</li>
<li>Entrepreneurial spirit and drive to positively impact global human health</li>
</ul>
 
Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to <a href="mailto:careers@vaxess.com" target="_blank">careers@vaxess.com</a>.

Process Engineer III

<h3>Job Description</h3>
Location:&nbsp;Woburn, MA
 
Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.&nbsp;
The Senior Mechanical Engineer is a hands-on position involving designing, building, and maintaining automated production equipment throughout its lifecycle. This role will be responsible for design, assembly, installation, qualification, ongoing maintenance, and optimization of automated production systems requiring expert troubleshooting of mechanical assemblies and systems, performing root cause analysis, and implementing corrective actions to ensure efficient, reliable manufacturing operations.&nbsp;
Working at Vaxess is cross-disciplinary, integrating chemistry, biology, immunology, mechanical, biomedical, and chemical engineering to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated individual to join our team. This is a unique opportunity to be part of an emerging startup and significantly influence the strategic growth and future direction of the company as we bring innovative technology to the global vaccine and therapeutic market.
 
Responsibilities
<ul>
<li>Design, implement, and maintain novel automated systems and solutions that contribute to current manufacturing and scale up of manufacturing operations to eventual commercialization.</li>
<li>Manage external vendors to develop plans, evaluate proposals, and ensure delivery of projects in-scope, within budget, and on time.</li>
<li>Document equipment and procedures though User Requirements Specifications, detailed mechanical, electrical, and assembly drawings, and use and maintenance SOPs. Contribute to the implementation and maintenance of the Quality Management System.</li>
<li>Collaborate closely with cross-functional teams to support product development and manufacturing activities, and to identify and resolve manufacturing issues.&nbsp;</li>
<li>Contribute to continuous improvement to increase safety, quality, and efficiency of manufacturing.</li>
</ul>
 
Qualifications
<ul>
<li>BS or advanced degree in Mechanical Engineering or a related discipline.&nbsp;</li>
<li>At least 10 years of experience in designing, building, installing, qualifying, and maintaining automated systems for high volume medical device&nbsp; manufacturing.&nbsp;</li>
<li>Experience writing and executing IQ, OQ and PQ protocols.&nbsp;&nbsp;</li>
<li>Experience developing URS, FAT and SAT documents for automated equipment</li>
<li>3D CAD (SolidWorks or similar) as well as Mechanical design of fixtures, assemblies and equipment.&nbsp;</li>
<li>Understanding and working knowledge of mechanical linkages, power transmissions and practices.&nbsp;</li>
<li>Understanding of diverse fabrication techniques, manufacturing processes, and Design for Manufacturability&nbsp;</li>
<li>Excellent time and project management skills and proven ability to meet goals and deadlines.</li>
<li>Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.</li>
<li>Entrepreneurial spirit and drive to positively impact global human health.</li>
</ul>

Senior Mechanical Engineer

<h3>Job Description</h3>
Principal Systems Engineer
Location: Andover, MA (In-person)
 
Company Overview
Digital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU regulatory frameworks, DHS helps clients accelerate product development while ensuring patient safety and clinical impact remain at the core. Our mission is simple yet powerful: to guide the development of medical technologies that improve and save lives.
 
Position Overview
We are seeking an accomplished Principal Systems Engineer to join our growing team. This role is ideal for a highly experienced systems thinker who thrives at the intersection of engineering, clinical application, and regulatory compliance. The Principal Systems Engineer will lead complex projects across Class II and III medical devices, bringing together cross-functional teams to deliver innovative solutions in areas such as neurostimulation, cardiac support, and medical imaging.
At DHS, you won’t just contribute technical, you will shape strategy, mentor emerging engineers, and influence the next generation of patient-focused technology. This is a hands-on leadership role where you’ll translate clinical needs into actionable requirements, architect and validate systems, and drive design control excellence from concept through commercialization.
We are looking for a candidate who combines technical depth, regulatory fluency, and leadership presence. The ideal candidate is someone who can balance innovation with compliance, build consensus across diverse stakeholders, and drive projects to successful completion in fast-paced environments.
 
Key Responsibilities
<ul>
<li>Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.</li>
<li>Translate user and clinical needs into system, subsystem, and component requirements while maintaining rigorous traceability.</li>
<li>Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.</li>
<li>Ensure requirements can be verified in compliance with design controls and other QMS SOPs.</li>
<li>Architect system-level solutions, define interfaces, and guide trade-off analyses to achieve optimal design outcomes.</li>
<li>Oversee risk management activities (HA, FMEA, risk-benefit analysis) ensuring compliance with ISO 14971 and related standards.</li>
<li>Direct verification and validation strategies, author test protocols/reports, and coordinate testing with external labs.</li>
<li>Drive design control documentation and ensure adherence to ISO 13485, IEC 60601, IEC 62304, and FDA/EU regulations.</li>
<li>Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams to resolve conflicts and ensure alignment.</li>
<li>Mentor junior engineers, fostering professional growth and building DHS’s technical leadership bench.</li>
<li>Contribute to program management activities including project planning, deliverable tracking, and executive reporting.</li>
<li>Support business development efforts through technical input to proposals, client engagement, and thought leadership.</li>
</ul>
 
Preferred Qualifications
<ul>
<li>Master’s degree in Biomedical, Electrical, Systems, or related Engineering field (PhD a plus).</li>
<li>10+ years of experience in systems engineering within Class II/III medical devices.</li>
<li>Proven track record in requirements management, system architecture, and verification/validation.</li>
<li>Strong knowledge of regulatory compliance (FDA 21 CFR Part 11/820, EU MDR, ISO 13485, IEC 60601, IEC 62304, ISO 14971).</li>
<li>Experience leading cross-functional teams, managing CAPAs, and closing complex regulatory gaps.</li>
<li>Skilled in tools such as JIRA, Confluence, and test management platforms.</li>
<li>Strong interpersonal skills with the ability to communicate effectively across technical and non-technical audiences.</li>
</ul>
 
What We Offer
<ul>
<li>Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.</li>
<li>The opportunity to work on cutting-edge medical technologies that directly improve patient lives.</li>
<li>Exposure to a broad range of projects and modalities, from implantable devices to advanced imaging systems.</li>
<li>Mentorship and collaboration with leading experts in systems engineering, regulatory affairs, and product development.</li>
<li>A role where your technical leadership and strategic insight shape both client success and DHS’s growth.</li>
<li>The satisfaction of delivering solutions that balance innovation, compliance, and patient safety—making a tangible impact in healthcare.</li>
</ul>

<h3>Job Description</h3>
Company Description:
AtaCor Medical is committed to advancing the standard of care in cardiac rhythm management. This mission drives our innovative approach and guides our work to help physicians restore rhythm and preserve life.
 
Position Summary:
This position supports the design and development of new products and product improvements in the extravascular cardiac rhythm management space. Responsibilities will include creation and evaluation of design requirements, development and execution of design verification test methods/protocols/reports, supplier interface and multi-disciplinary project team participation. This position is a full-time, on-site role located at our San Clemente, CA office.&nbsp;
 
Essential Functions:
<ul>
<li>Provides engineering support for design and development of new products and product changes</li>
<li>Use computer-assisted design software (i.e., SolidWorks) to perform engineering and design tasks</li>
<li>Develops and tests prototypes based on design specifications, defines processes to properly manufacture and assemble the product, and optimizes the manufacturing process</li>
<li>Analyzes test data to determine if designs meet functional and performance requirements and document findings in test reports</li>
<li>Conduct engineering inspections of returned product from clinical studies to support complaint and CAPA investigations</li>
<li>Support updates and improvements to QMS procedures</li>
<li>Evaluate the impact of external standard changes on products and their Design History Files (DHFs)</li>
<li>Leverage knowledge of Risk Management, Regulations, and Procedures to ensure continued product compliance</li>
<li>Provides design verification test reports, drawings, and other requirements to Regulatory Affairs necessary for preparing regulatory notifications and submissions such as 510(k)s and PMAs for domestic and international approvals as required</li>
<li>Determines realistic start and finish dates for action items imperative to project completion on the project schedule and submits to the project team leader. Provides updates to project schedule as required</li>
<li>Identify areas for improvement in lab tooling and technical processes across all project phases and recommend changes to the appropriate management.</li>
<li>Supports management of Engineering Lab and provides technical training for appropriate Lab personnel</li>
<li>Reviews appropriate technical literature for the necessary background on specific assignments</li>
<li>All activities must be performed in compliance with the Quality System</li>
<li>Performs duties in compliance with environmental, health, and safety-related site rules, policies, or government regulations</li>
</ul>
 
Essential Qualifications:
<ul>
<li>Education:&nbsp;BS in Biomedical Engineering, Mechanical Engineering, or equivalent combination of education and experience.</li>
<li>Experience:&nbsp;0-3 years industry experience, preferably in medical device design environment.</li>
<li>Working knowledge of light machine shop practice and operation; ability to use shop tools such as drill press, drills, heat sealer, and pull test equipment.</li>
<li>Working knowledge of current CAD tools</li>
<li>Experience in the use of analytical tools and methods including statistics, DOE, and computer analysis packages.</li>
<li>Excellent teamwork and interpersonal skills.</li>
<li>Travel: Up to 15-25%</li>
</ul>
 
Desirable Skills:
<ul>
<li>Experience with SolidWorks</li>
<li>Experience working within an ISO or FDA type design control environment.</li>
<li>Experience working with a contract engineering or manufacturing firm.</li>
<li>Cardiac pacing/defibrillation, implantable, or surgical medical device experience</li>
</ul>

854 biomedical engineer Jobs