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city

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<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 Senior Manufacturing Engineer 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 Manufacturing, Design Engineering and Quality Control/Assurance departments to ensure production line sustainability, compliance with regulations, and quality systems requirements. The Senior Manufacturing Engineer will be responsible for deploying 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 guide and mentor the engineering team and other departments in resolving manufacturing and production issues, improving engineering and project systems, and identifying and resolving product or process 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>Implement corrective and preventive actions for production non-conformances.</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>Implement corrective and preventive actions for production non-conformances.</li>
<li>Provide troubleshooting expertise for equipment-related issues and offer technical support to operators and technicians as required.</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>Perform analysis and provide input to mitigate risk due to obsolete or high-risk equipment and parts.</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>Experience with optical measurement systems (Keyence, NEMO, or similiar)</li>
<li>Demonstrate strong problem-solving skills and can ask critical questions without being the subject matter expert.</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>
EDUCATION, EXPERIENCE, and TRAINING:
<ul>
<li>Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 7 years of technical experience.</li>
<li>Master’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 5 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>
<li>Training to be completed per the training plan for this position as maintained in the document control system</li>
<li>The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis</li>
</ul>
COMPUTER SKILLS:
<ul>
<li>Microsoft Word; Microsoft Excel; Teams</li>
<li>MiniTab</li>
<li>Project Management System (SmartSheet preferred)</li>
<li>CAD (SolidWorks or PRO/E proficiency 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.

Senior Manufacturing Engineer

<h3>Job Description</h3>
About Nevro
Nevro, now part of Globus Medical, is a global medical device company focused on improving the quality of life for patients with chronic pain. We developed and commercialized the Senza® platform, including the Omnia™ and HFX iQ™ systems—the only spinal cord stimulators that deliver Nevro’s proprietary HF10® therapy, a paresthesia-free, evidence-based treatment proven to reduce or eliminate opioid use in a majority of patients.
 
With HFX iQ, Nevro introduced a smart and adaptive stimulation platform, designed to personalize therapy based on real-time patient input and automatic optimization. Our neuromodulation systems continue to redefine what’s possible in the treatment of chronic pain.
 
About the Role
We are seeking a Principal Mechanical Engineer to join our innovative R&amp;D team focused on neuromodulation. You will be a technical leader responsible for the design, development, and verification of next-generation implantable Class III devices and their associated tools and systems. This role blends hands-on engineering with high-level design leadership, requiring expertise in miniaturization, biocompatible materials, and chronic-implant reliability.
You’ll work across disciplines—including systems, electrical, clinical, and manufacturing—to bring smart, durable, patient-centric devices to life.
 
Key Responsibilities
Product Design &amp; Architecture
<ul>
<li>Lead mechanical design of implantable pulse generators (IPGs), leads, surgical tools, and accessories.</li>
<li>Own product-level decisions on form factor, sealing, integration, and structural performance.</li>
<li>Apply best practices in DFM/DFX to balance functionality, usability, and manufacturability.</li>
</ul>
Materials &amp; Processes
<ul>
<li>Select and qualify materials for chronic implantation (e.g., titanium, PEEK, silicone, polyimide, Pt/Ir).</li>
<li>Develop and refine assembly processes involving hermetic sealing, laser welding, overmolding, and adhesive bonding.</li>
<li>Collaborate with suppliers and internal teams on microfabrication, metal forming, and cleanroom assembly.</li>
</ul>
Testing &amp; Reliability
<ul>
<li>Define and execute verification testing for fatigue, vibration, drop, thermal cycling, fluid ingress, and long-term soak.</li>
<li>Lead root cause analysis and implement design mitigations for mechanical failure modes.</li>
<li>Contribute to the development of custom test methods, jigs, and accelerated aging protocols.</li>
</ul>
Documentation &amp; Compliance
<ul>
<li>Generate engineering documentation in support of design controls (e.g., DHF, FMEA, test protocols, reports).</li>
<li>Participate in design reviews and risk analyses in compliance with FDA, ISO 13485, and IEC 60601 standards.</li>
<li>Drive and process ECOs and support regulatory submissions as needed.</li>
</ul>
Clinical &amp; Cross-Functional Collaboration
<ul>
<li>Gather and integrate feedback from physicians, patients, and clinical staff to inform iterative product design.</li>
<li>Collaborate with systems engineering, electronics, software, and clinical teams to ensure robust product integration.</li>
<li>Communicate effectively across functions and present findings to senior management.</li>
</ul>
Leadership &amp; Mentoring
<ul>
<li>Provide technical direction to cross-functional development teams.</li>
<li>Mentor junior engineers and support team growth through knowledge sharing and design leadership.</li>
</ul>
 
Qualifications
<ul>
<li>Bachelor’s degree in Mechanical, Biomedical, or related Engineering field (MS or PhD preferred).</li>
<li>8+ years of experience in medical device design, with at least 4 years focused on implantable Class III devices.</li>
<li>Expertise in CAD (SolidWorks or similar), tolerance stack-ups, FEA, and GD&amp;T.</li>
<li>Proven experience with biocompatible materials, hermetic device design, and implantable reliability engineering.</li>
<li>Familiarity with manufacturing methods like micro-welding, injection molding, and precision machining.</li>
<li>Strong understanding of medical device regulatory and quality standards (21 CFR 820, ISO 13485, ISO 14708, ISO 10993).</li>
<li>Demonstrated ability to lead by influence, drive complex programs, and thrive in a dynamic R&amp;D environment.</li>
</ul>
 
Why Join Us?
At Nevro, you'll help shape the future of neuromodulation—developing smart, patient-responsive devices that make a tangible difference in the lives of people living with chronic pain. As part of the Globus Medical family, we combine the scale and resources of a global medtech leader with the agility and innovation of a startup. If you're passionate about deeply technical work that truly matters, we'd love to talk.
 
Target Pay Range 
 
The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.
 
EEO Statement 
 
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age or other characteristics protected by laws.
 
1Senza HFX iQ™ uses a fixed set of instructions to provide optimized treatment recommendations that utilize direct patient input from assessments on pain and quality of life measures.

Principal Mechanical Engineer - Neuromodulation (Neurostimulators)

<h3>Job Description</h3>
Job DescriptionSalary: 
 
Purpose
The Project Engineer will support existing and new products with project management and development. This will include product management, prototyping, testing, and marketing associated with products.
 
Responsibilities
<ul>
<li>Manage and execute product development projects from ideation to market launch</li>
<li>Lead project management activities on assigned projects including schedule, budget, work products and deliverables</li>
<li>Execute projects following design control practices and developing the necessary project inputs and outputs required for each development phase</li>
<li>Organize appropriate methods of communication between project stakeholders</li>
<li>Collect, organize, and communicate customer and market feedback to identify critical product characteristics</li>
<li>Develop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departments</li>
<li>Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable</li>
<li>Review, analyze, and characterize critical financial characteristics of products including COGS</li>
<li>Conduct group trainings for new processes and complete technology transfer of new products</li>
<li>Perform processing of human tissue as part of the development of new processes</li>
<li>Design and execute scientific experiments for product development projects. Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch</li>
<li>Specify, order, evaluate, and onboard new proprietary equipment in support of products</li>
<li>Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support</li>
<li>Design and develop custom manufacturing equipment if applicable</li>
<li>Support and expand existing product lines by responding to business development needs, collecting, and organizing product feedback, and improving and supporting products</li>
<li>Support the development and implementation of sales material for products and work with Quality Assurance to ensure all claims are appropriate for market and regulatory position</li>
<li>Conduct literature reviews to support new and existing products</li>
<li>Assist with investigation of product quality events and appropriate preventative/corrective actions</li>
<li>Support regulatory and reimbursement submissions for products</li>
<li>Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports</li>
<li>Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance's required for assigned product development projects</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>Perform other duties as assigned</li>
<li>Maintain acceptable attendance and punctuality for scheduled work hours and meetings</li>
<li>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>Complete required hours on assigned duties works shift to complete assigned responsibilities and duties</li>
</ul>
Skills
<ul>
<li>Project Management experience</li>
<li>Ability to present complex ideas</li>
<li>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>
</ul>
Qualifications/Requirements
<ul>
<li>Bachelor's degree in biomedical or mechanical engineering or related field required</li>
<li>3 years of experience in project management required</li>
<li>Experience with Mechanical Design</li>
<li>Experience with CAD Software</li>
<li>Education in Engineering, or Biological Science or related field preferred</li>
<li>Product Development and exposure to medical products preferred</li>
<li>Experience with allografts and/or medical devices preferred</li>
<li>Clearance of favorable background investigation required</li>
</ul>

Project Engineer - Tissue

<h3>Job Description</h3>
Job DescriptionSENIOR MECHANICAL ENGINEER
Freeform is deploying software-defined, autonomous metal 3D printing factories around the world, bringing the scalability of software to physical production. Our proprietary technology stack leverages advanced sensing, real-time controls, and data-driven learning to produce digitally-verified, flawless parts at unprecedented speed and cost. Our mission is to make the transformative power of 3D printing available to all industries at scale and unlock the future of innovation. 
As a Senior Mechanical Engineer at Freeform, you will be responsible for leading mechanical design efforts across the company, as well as for driving the pace of innovation and maximizing hardware development speed. To be successful in this role, you must have extensive technical breadth in mechanical engineering concepts as well as specific expertise in architecting, designing, and developing complex mechanical systems, advanced robotics systems, or state-of-the-art industrial automation systems. The ideal candidate is capable of acting as the technical lead for a complex system with the ability work across engineering disciplines.
3D printing experience is not required to be successful here - rather we look for smart, motivated, collaborative engineers who love solving hard problems and creating amazing technology! 
Responsibilities:
<ul>
<li>Act as a responsible engineer in bringing hardware from concept to production</li>
<li>Research, develop, design, and test complex mechanical components, subassemblies, equipment, and systems</li>
<li>Perform tolerance analysis of designs at the system and subsystem level</li>
<li>Plan and perform tests to analyze the feasibility, design, operation and performance of equipment, components, and systems</li>
<li>Work hands-on to build, integrate, and validate designs and newly developed systems and/or subsystems</li>
<li>Strategize continuous improvement plans to enhance system performance, reliability, and manufacturability</li>
</ul>
Basic Qualifications:
<ul>
<li>Bachelor's degree in mechanical engineering or related technical field</li>
<li>5+ years of experience in mechanical systems design and development</li>
<li>CAD experience, including GD&amp;T and detailed drawing documentation</li>
<li>Strong mechanical engineering fundamentals with extensive hands-on hardware development experience</li>
<li>Systems-level thinker also able to perform detailed work; has previously delivered complex mechanical systems</li>
</ul>
Nice to Have:
<ul>
<li>10+ years of experience designing mechanical systems for semiconductor, machining, automation, materials processing, or other related industrial manufacturing or capital equipment applications (e.g. additive manufacturing, semiconductor, robotics, CNC, or biomedical manufacturing equipment design engineering experience)</li>
<li>Advanced degree in mechanical engineering</li>
<li>Knowledge of motion control and kinematics</li>
<li>Experience with design of fluid or thermal systems</li>
<li>Working knowledge of electromechanical systems</li>
<li>Passion for improving the state of metal 3D printing</li>
<li>Excellent verbal and written communication skills</li>
</ul>
Location:
<ul>
<li>We are located in Hawthorne, CA in a 35,000 square foot, state-of-the-art facility featuring large open spaces for team collaboration, R&amp;D, and production, as well as easy access to the 405, 105, and 110 freeways. Our facility is in the heart of Los Angeles' vibrant emerging tech ecosystem alongside many other high growth startups and enterprises.</li>
</ul>
What We Offer:
<ul>
<li>We have an inclusive and diverse culture that values collaboration, learning, and making deliberate data-driven decisions.</li>
<li>We offer a unique opportunity to be an early and integral member of a rapidly growing company that is scaling a world-changing technology.</li>
<li>Benefits
<ul>
<li>Significant stock option packages</li>
<li>100% employer-paid Medical, Dental, and Vision insurance (premium PPO and HMO options)</li>
<li>Life insurance</li>
<li>Traditional and Roth 401(k)</li>
<li>Relocation assistance provided</li>
<li>Paid vacation, sick leave, and company holidays</li>
<li>Generous Paid Parental Leave and extended transition back to work for the birthing parent</li>
<li>Free daily catered lunch and dinner, and fully stocked kitchenette</li>
<li>Casual dress, flexible work hours, and regular catered team building events</li>
</ul>
</li>
<li>Compensation
<ul>
<li>As a growing company, the salary range is intentionally wide as we determine the most appropriate package for each individual taking into consideration years of experience, educational background, and unique skills and abilities as demonstrated throughout the interview process. Our intent is to offer a salary that is commensurate for the company's current stage of development and allows the employee to grow and develop within a role. </li>
<li>In addition to the significant stock option package, the estimated salary range for this role is $110,000-$200,000, inclusive of all levels/seniority within this discipline.</li>
</ul>
</li>
<li>Freeform is an Equal Opportunity Employer that values diversity; employment with Freeform is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status. </li>
</ul>

Senior Mechanical Engineer

<h3>Job Description</h3>
Job Description
Job Description:
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Reporting to Chief Technical Officer
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Looking for a creative developer excited by the prospect of bringing novel biotechnology to market in a fast-paced start-up environment.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The successful candidate will lead the mechanical development team of the Proteowise instrument and the disposable fluidic devices that go with it.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsibility extends from breadboards and prototypes through close involvement with the manufacturing teams who will implement the candidate’s designs into commercial products.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be hands-on with prototypes and evaluate their designs in the lab.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the internal cross-functional development team of Software Engineers, Electrical Engineers, Optical Engineers, Biologists and Chemists to ensure systems are successfully implemented.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the Manufacturing and Quality teams to transfer manufacturable designs.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the Industrial design partner to faithfully implement the Proteowise vision.
Skill &amp; Experience Requirements:
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be fluent in the design and debugging methods of mechanical systems, and capable of producing mechanical parts and subsystems in house and using 3rd party suppliers.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be expert in Solidworks.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience with fluidic analyses and simulations a plus.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Successful track record of commercial launch, especially launching fluidic, microfluid disposables a plus
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; BS Mechanical or BS Biomedical Engineer. MS or PhD a plus.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5 years industry experience. More a plus.

Lead Mechanical Engineer

<h3>Job Description</h3>
Job Description
Summary: Hiring a Human Factors Engineer with a specialization in drug delivery devices and capable of working autonomously.
Job Requirements:
<ul>
<li>
Must understand human factors engineering
</li>
<li>
Minimum of 4 years industry experience in HFE (excluding academic experience)
</li>
<li>
Bachelor's degree or higher in human factors engineering, biomedical engineering, or mechanical engineering
</li>
<li>
Must be vaccinated
</li>
</ul>
Preferred Skills:
<ul>
<li>
Exceptional technical writing and communication abilities
</li>
<li>
Experience leading HFE studies, including planning, writing protocols, moderating, note taking, analyzing and reporting
</li>
<li>
Ability to author end-to-end HFE documents for regulated medical devices
</li>
</ul>
Job Responsibilities:
<ul>
<li>
Support HFE/UE planning, research, development of drug delivery devices using HFE/UE best practices in accordance with current regulations within the medical device, combination product and bio-pharmaceutical industries
</li>
<li>
Lead study data collection, root cause analysis and report writing to inform design
</li>
<li>
Apply sound HFE/UE knowledge and experience to research, development, clinical studies and product validation in support of regulatory submissions.
</li>
</ul>
 Pay Details: $48.00 to $64.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to <a href="https://www.entegee.com/candidate-privacy-information-statement/" target="_blank">https://www.entegee.com/candidate-privacy-information-statement/</a> The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

Human Factors Engineer

<h3>Job Description</h3>
Job Description
Summary: Seeking a Product Development Engineer with experience in medical device or pharmaceutical product development.
Job Requirements:
<ul>
<li>
B.S. in Chemistry, Biochemistry, Chemical Engineering or Biomedical Engineering
</li>
<li>
2-4 Years of experience in medical device, pharmaceutical, or food product development
</li>
<li>
Strong chemical background and knowledge of Laboratory Equipment and Procedures Testing Instrumentation
</li>
<li>
Basic knowledge of Product or Process Validations
</li>
<li>
Basic understanding of cGMP and regulatory requirements (medical devices and/or drugs)
</li>
<li>
Familiarity with dental medical devices
</li>
</ul>
Preferred Skills:
<ul>
<li>
Design of Experiments
</li>
<li>
Experience with MS Office products for writing protocols, reports, and presentations
</li>
</ul>
Job Responsibilities:
<ul>
<li>
Provide project leadership to multiple projects at once, ensuring timelines and budgets are appropriately managed
</li>
<li>
Formulate prototypes, lab batches and prepare sample requests
</li>
<li>
Complete evaluations as outlined in engineering studies, protocols, product / process validations, complaint evaluations etc.
</li>
<li>
Assist in developing/performing test method including validation protocol/reports for active pharmaceutical ingredients and/or finished product specifications
</li>
<li>
Assist in gathering raw materials, pre-weighting and scaling up for pilot batches and packaging with supervision
</li>
</ul>
 Pay Details: $38.00 to $51.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to <a href="https://www.entegee.com/candidate-privacy-information-statement/" target="_blank">https://www.entegee.com/candidate-privacy-information-statement/</a> The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

Product Development Engineer

<h3>Job Description</h3>
Job Description
Job Title: Senior Manufacturing Engineer
<ul>
<li>Location: Newark, DE 19702</li>
<li>Pay Rate: $48 - $60 per hour</li>
<li>Schedule: Monday – Friday, 1st Shift (8:00 AM – 5:00 PM)</li>
<li>Job Type: Contract (6 months, potential to extend or convert)</li>
</ul>
About the Role: We are seeking a Senior Manufacturing Engineer to support a leading medical device manufacturing operation in Newark, DE. This is a hands-on role where your expertise will directly impact production performance, quality, and efficiency. If you excel in solving complex manufacturing issues and thrive in a fast-paced, highly regulated environment, we want to hear from you.
What You’ll Do:
<ul>
<li>
Lead manufacturing implementation of sustaining design projects
</li>
<li>
Troubleshoot production issues and drive root cause analysis, corrective and preventative actions
</li>
<li>
Develop and execute validation plans, including IQ, OQ, and PQ
</li>
<li>
Create and update process documentation including PFMEAs, Control Plans, and Process Flowcharts
</li>
<li>
Lead and facilitate Lean Manufacturing initiatives (5S, VSM, Kanban, Kaizen)
</li>
<li>
Interface with contract manufacturers and cross-functional teams to ensure processes are optimized and risks mitigated
</li>
<li>
Monitor product quality and field performance, identify trends, and implement corrective actions
</li>
<li>
Support continuous improvement in manufacturing processes and systems
</li>
</ul>
What We’re Looking For:
<ul>
<li>
Education: Bachelor’s Degree in Engineering (Mechanical, Electrical, Electro-Mechanical, Biomedical preferred)
</li>
<li>
Experience: 5-8 years in manufacturing or manufacturing engineering; medical device industry experience highly preferred
</li>
<li>
Strong background in troubleshooting complex manufacturing challenges
</li>
<li>
Extensive experience with validation activities and documentation
</li>
<li>
Proficient in Lean Manufacturing methodologies
</li>
<li>
Experience with PLM (Agile preferred) and ERP systems (Oracle preferred)
</li>
<li>
Hands-on experience with SolidWorks and LabView preferred
</li>
<li>
Self-starter with excellent communication and collaboration skills
</li>
</ul>
Why Join Us:
<ul>
<li>
Work with cutting-edge medical device technologies
</li>
<li>
Join a highly collaborative team where your ideas drive results
</li>
<li>
Potential for contract extension or direct hire based on performance and business needs
</li>
<li>
Competitive hourly compensation
</li>
</ul>
Physical Requirements:
<ul>
<li>
Ability to lift and move up to 30 pounds
</li>
<li>
Work may involve exposure to mechanical parts, moderate noise, and occasional high voltage equipment
</li>
<li>
Safety shoes required in designated areas
</li>
</ul>
Ready to make a difference? Apply today to join a team where innovation and excellence are at the heart of everything we do!
Job ID: bh17861
Company DescriptionConnexion Systems &amp; Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve. 
<h3>Company Description</h3>
Connexion Systems &amp; Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

<h3>Job Description</h3>
Job Description
Akkodis is seeking an RD Engineer III for a Contract job with a client in MG (onsite). The ideal candidate must have experience in the design and development of implants, CAD modeling, FEA simulations, and a strong background in medical devices, particularly cardiovascular implants.
Rate Range: $55/hour to $58/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
RD Engineer III job responsibilities include:
<ul>
<li>
Participate in product design and development, material testing, and process documentation.
</li>
<li>
Independently plan and schedule activities to meet project timelines.
</li>
<li>
Design and coordinate engineering tests, tooling, and fixtures.
</li>
<li>
Troubleshoot product/process issues related to design, materials, or manufacturing.
</li>
<li>
Analyze and summarize test results and prepare technical documentation.
</li>
<li>
Invent and submit new product/process concepts.
</li>
<li>
Collaborate with cross-functional teams including quality, manufacturing, regulatory, and clinical.
</li>
<li>
Demonstrate knowledge of PDP/TPD systems through high-quality deliverables.
</li>
</ul>
Desired Qualifications:
<ul>
<li>
Bachelor’s Degree in Mechanical, Biomedical, Chemical Engineering, or related field.
</li>
<li>
5+ years of experience with a BS degree or 3–4 years with an MS degree.
</li>
<li>
Experience in implant design and development.
</li>
<li>
Proficiency in CAD modeling and FEA simulations.
</li>
<li>
Strong understanding of human anatomy and cardiovascular implants.
</li>
<li>
Medical device industry experience.
</li>
</ul>
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at <a href="mailto:sunny.kumar1@akkodisgroup.com" target="_blank">mailto:sunny.kumar1@akkodisgroup.com</a>"&gt;sunny.kumar1@akkodisgroup.com.
 Pay Details: $55.00 to $58.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to <a href="https://www.akkodis.com/en/us/candidate-privacy-policy" target="_blank">https://www.akkodis.com/en/us/candidate-privacy-policy</a> The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: 
<ul>
<li>The California Fair Chance Act</li>
<li>Los Angeles City Fair Chance Ordinance</li>
<li>Los Angeles County Fair Chance Ordinance for Employers</li>
<li>San Francisco Fair Chance Ordinance</li>
</ul>
 Company DescriptionGlobal Footprint, Local Impact: As part of the world's second-largest ER&amp;D company, you'll join a network of 50,000 professionals across 30 countries, each contributing to impactful projects worldwide while benefiting from a close-knit community at a local level. Diverse Career Paths: With services ranging from specialist recruitment to cloud infrastructure and sustainability, Akkodis offers a multitude of career paths. Whether you're a software developer, data analyst, or sustainability expert, there's a place for your skill set. Commitment to Innovation: Innovation is our cornerstone. With continuous investments in analytics and market intelligence, we not only predict the future of technology – we create it. Your ideas and innovations will have the space to flourish. Continuous Learning and Development: The Akkodis Academy offers unrivaled opportunities for learning and professional growth, ensuring you remain at the forefront of your field. Our culture values continuous improvement, both for our company and for your career. Inclusive and Collaborative Culture: We believe in the power of diverse perspectives and collaborative work environments. At Akkodis, you'll find a community where inclusivity drives innovation and where every voice is heard. Our Evolution and Your Role in It Akkodis emerged from the strategic merger of AKKA Technologies and Modis in 2023, under the Adecco Group. This fusion created a powerhouse in digital engineering and technology, blending European engineering finesse with global technological capabilities. As we write our next chapter, your skills and vision will be instrumental in driving our continued success. Empowering the Future We're not just creating solutions; we're empowering industries to be more efficient, sustainable, and forward-thinking. Our work in industrial automation, product development, and custom software solutions is setting new standards in technology and engineering. Join the Akkodis Community At Akkodis, you're more than just an employee – you're a vital part of a community shaping the future. We're excited to see where your expertise can take us. Discover where you fit in our diverse range of opportunities and start engineering a smarter future with us today. 
<h3>Company Description</h3>
Global Footprint, Local Impact: As part of the world's second-largest ER&amp;D company, you'll join a network of 50,000 professionals across 30 countries, each contributing to impactful projects worldwide while benefiting from a close-knit community at a local level.\r\n\r\nDiverse Career Paths: With services ranging from specialist recruitment to cloud infrastructure and sustainability, Akkodis offers a multitude of career paths. Whether you're a software developer, data analyst, or sustainability expert, there's a place for your skill set.\r\n\r\nCommitment to Innovation: Innovation is our cornerstone. With continuous investments in analytics and market intelligence, we not only predict the future of technology – we create it. Your ideas and innovations will have the space to flourish.\r\n\r\nContinuous Learning and Development: The Akkodis Academy offers unrivaled opportunities for learning and professional growth, ensuring you remain at the forefront of your field. Our culture values continuous improvement, both for our company and for your career.\r\n\r\nInclusive and Collaborative Culture: We believe in the power of diverse perspectives and collaborative work environments. At Akkodis, you'll find a community where inclusivity drives innovation and where every voice is heard.\r\n\r\nOur Evolution and Your Role in It\r\n\r\nAkkodis emerged from the strategic merger of AKKA Technologies and Modis in 2023, under the Adecco Group. This fusion created a powerhouse in digital engineering and technology, blending European engineering finesse with global technological capabilities. As we write our next chapter, your skills and vision will be instrumental in driving our continued success.\r\n\r\nEmpowering the Future\r\n\r\nWe're not just creating solutions; we're empowering industries to be more efficient, sustainable, and forward-thinking. Our work in industrial automation, product development, and custom software solutions is setting new standards in technology and engineering.\r\n\r\nJoin the Akkodis Community\r\n\r\nAt Akkodis, you're more than just an employee – you're a vital part of a community shaping the future. We're excited to see where your expertise can take us. Discover where you fit in our diverse range of opportunities and start engineering a smarter future with us today.

R&D Engineer III

<h3>Job Description</h3>
Job Description
ABOUT ORGANOX: 
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 4,000 liver transplant operations globally, optimizing the use of donated organs by enabling assessment of the quality of livers as well as longer preservation durations. As part of our ongoing expansion, we seek a Clinical Training Manager to join our team. 
Position Summary 
The Field Service Engineer-United States will be primarily responsible for the on-site service and repair of complex electro-mechanical medical devices designed for organ preservation placed within United States region. Reporting to the National Director of Field Service Engineering, the postholder will be responsible for providing technical support for OrganOx metra retained units placed in United States to ensure that product reliability, quality and availability are maintained. The Field Service Engineer – United States will be responsible for completing all documentation relevant to installation, service, repair and rework in compliance with FDA “Good Documentation Practice” and “Good Manufacturing Practice”. 
Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete additional tasks reasonably requested by the Product Support Manager. 
Major Responsibilities 
<ul>
<li>Under direction from the National Director of Field Service Engineering, the Field Service Engineer – United States will be responsible for: </li>
<li>Organizing and providing on-site service and repair of the OrganOx metra device: </li>
<li>Travelling to hospitals and research facilities within United States. </li>
<li>Carrying out on-site routine maintenance procedures and liaising directly with customers regarding organizing routine services and other maintenance needs of OrganOx devices. </li>
<li>Carrying out on-site or back-to-base troubleshooting and re-work of OrganOx devices. </li>
<li>Carrying out Installation Testing, Post-Rework Soak and Acceptance Testing and completing all documentation in compliance with Good Documentation Practice and the OrganOx Quality Management System. </li>
<li>Ensuring work orders and service visits are completed within set time frames. </li>
<li>Assisting with major back-to-base repairs or device upgrades in OrganOx USA workshop, when necessary. </li>
<li>Short-term covering for the urgent technical needs of devices placed outside United States when the engineer assigned for that region is not available. </li>
<li>Working with the National Director of Field Service Engineering to maintain a stock of spare parts and consumables necessary for the technical support of the devices within United States. </li>
<li>Managing a local spare part stock in a local facility and trunk stock within United States under the guidance of the Director of Field Service Engineering. </li>
<li>Managing and maintenance, including recalibration, of various test equipment, battery calibrators, tools and accessories required during providing technical service within United States. </li>
<li>Complete technical documentation as required under the regulatory frameworks and standards for medical devices </li>
<li>Completing technical reports to a high standard. </li>
<li>To assist the Product Support Manager in maintaining the technical documentation and device history records. </li>
<li>Ensure that vendor credentialing requirements are current. </li>
<li>Adhere to the letter &amp; spirit of the OrganOx Code of Conduct and other company policies. </li>
</ul>
Requirements
Skills and Experience
The Field Service Engineer – United States will have: 
<ul>
<li>A strong and broad working knowledge of electrical and mechanical engineering systems. </li>
</ul>
<ul>
<li>A good track record of demonstrating analytical problem-solving skills. </li>
</ul>
<ul>
<li>Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team. </li>
</ul>
<ul>
<li>Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English. </li>
</ul>
<ul>
<li>Freedom to travel within United States to carry out servicing, repairs, trouble shooting, and other device maintenance activities as required. </li>
</ul>
<ul>
<li>Commitment to travel with short notice and to stay away from home for several consecutive days at a time. Travel and onsite servicing will average 80% of working time; this could potentially increase to 90% of working time during specific peaks of activity (such as deployment of fleet-wide upgrades). </li>
</ul>
<ul>
<li>A willingness to work unsocial hours, including weekends and public holidays, when necessary to support customer needs. </li>
</ul>
<ul>
<li>Possession of a Driving License with ability of driving within the United States of America and ability to use company funded rental vehicles. </li>
</ul>
<ul>
<li>Good written and verbal communication skills in English. (essential). </li>
</ul>
<ul>
<li>Be friendly, approachable, and have excellent interpersonal skills </li>
</ul>
<ul>
<li>Be prepared to accept a high degree of responsibility. </li>
</ul>
<ul>
<li>Highly observant of people and procedures. </li>
</ul>
<ul>
<li>Have an analytical approach to problem solving. </li>
</ul>
<ul>
<li>Be willing to work alone within hospital/laboratory environments.</li>
</ul>
REQUIREMENTS
The Field Service Engineer-United States will have: 
<ul>
<li>A minimum of an Associate's degree or higher in electrical, electronic, mechanical or biomedical engineering, or other relevant discipline (essential).</li>
<li>Three years or more industry experience servicing and repairing Medical Devices or other complex critical devices is required.</li>
</ul>
<ul>
<li>A good understanding of complex electro-mechanical systems and software (essential). </li>
</ul>
<ul>
<li>Excellent knowledge of key office software, including Excel, Word and PowerPoint (essential). </li>
</ul>
<ul>
<li>Good hands-on experience with a broad range of test equipment, including oscilloscopes, spectrum analyzers and data loggers (essential).</li>
</ul>
<ul>
<li>Prior experience servicing, repairing, testing, and trouble-shooting medical devices within hospitals environments and research facilities (desirable).</li>
</ul>
<ul>
<li>Experience of working with Safety and Quality Standards applicable to medical devices (desirable). </li>
<li>Must be able to commit to travel with short notice 80% or more of working time.</li>
</ul>
<ul>
<li>Geographically located within assigned territory 45 minutes from a major airport (essential). </li>
</ul>
<ul>
<li>Ability to lift and carry 50lbs (essential).</li>
</ul>
A job description does not imply that the duties stated are the only ones to be performed by the job holder. Employees will be required to follow any other job-related instruction as requested by their manager. 
#LI-Remote
Benefits
The Pay Range for this position is $115,000 - $135,000 annually, with a 10% target annual bonus and benefits.
WHAT WE OFFER: 
At OrganOx, we offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. 
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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