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<h3>Job Description</h3>
Job Description
Field Service Engineer (PERM or Temp-To-Perm) Location: Seekonk, MA area&nbsp; Salary:&nbsp;$80 - 90K range&nbsp;(depending on experience) **Bonus comp variable plan** - depending on team performance. Est: $10-15K in additional comp. Notes:
<ul>
<li>Looking for candidates who are close to the Seekonk, MA&nbsp;area because company has a warehouse in that location where this person will be troubleshooting, and providing maintenance&nbsp;repair / refurbishment on lab equipment.&nbsp;</li>
<li>Looking for candidates with Becton Dickinson Flow Cytometry and Hamilton Liquid handler experience</li>
<li>There is also travel involved with&nbsp;this role to visit clients in the area - which will be 25-50% (and overnight in a lot of cases)</li>
</ul>
 Seeking a skilled Analytical Instrument Service Specialist to join our team! In this role, you will be responsible for the troubleshooting, repair, maintenance, and calibration of complex analytical systems, ensuring optimal performance across biotechnology, pharmaceutical, chemical manufacturing, and environmental industries. If you thrive on solving technical challenges, keeping mission-critical instruments running, and working in a dynamic lab environment, this role is for you! Responsibilities •Perform diagnostic troubleshooting, repairs, and routine maintenance on a variety of complex analytical instruments, including: •HPLC, GC-MS, LC-MS systems from Agilent, Thermo Fisher, Waters, SCIEX, Shimadzu, Bruker, PerkinElmer, and others •Flow cytometers from BD Biosciences, Beckman Coulter, Thermo Fisher, Sony Biotechnology, and others •Liquid handlers and automation systems from Tecan, Hamilton, Beckman Coulter, Agilent, PerkinElmer, and others •Other laboratory instrumentation utilized in biotech, pharmaceutical, chemical, and environmental industries •Conduct preventative maintenance and calibration to ensure instruments meet manufacturer specifications and regulatory requirements. •Collaborate with scientists, lab managers, and technical teams to identify and resolve instrument performance issues. •Maintain detailed service records, calibration logs, and compliance documentation for audit readiness. •Provide technical support and training to end-users on proper instrument operation and best practices. •Assist in the installation and qualification (IQ/OQ/PQ) of new analytical instruments. •Stay up to date on emerging technologies, troubleshooting methods, and industry regulations. •Ability to travel up to 25-50% overnight within the assigned territory. •Be a customer-oriented professional, acting as a promoter of EquipNet in customer laboratories and proactively driving business growth. •Coordinate problem resolution with engineering, customer service, and other personnel to expedite repairs and improve response times. •Serve as a communication link between the customer and the company to ensure effective service delivery and strong client relationships. Requirements •Strong mechanical, electrical, and troubleshooting skills for analytical instrumentation. •Ability to diagnose complex system failures and implement solutions efficiently. •Excellent verbal and written communication skills to explain technical concepts to both experts and non-experts. •Strong organizational skills with attention to detail and compliance. •Ability to work independently and manage multiple service requests. •Ability to perform occasional lifting of equipment •Ability to work independently within a customer location while maintaining a high level of service. Experience and Education •Associate’s or bachelor’s degree in engineering, Instrumentation, Analytical Chemistry, Biomedical Engineering, or a related field (or equivalent experience). •3+ years of hands-on experience servicing and troubleshooting laboratory instruments in biotech, pharma, chemical, or environmental industries. •Prior experience with HPLC, LC-MS, GC-MS, or automation systems is highly preferred. •Experience with vendor software (e.g., MassLynx, Xcalibur, Empower, OpenLab, FlowJo, CytExpert, or equivalent) is a plus. •Knowledge of GLP/GMP compliance and industry regulations is desirable. •Well-developed PC skills, including Windows 2000/XP, Windows 7, Windows 10, and Microsoft Office Suite. •Possess a valid driver’s license. •*** Hamilton Liquid Handlers experience required. •***Becton Dickinson Flow Cytometry experience required. Compensation and Benefits · Based on experience · Bonus compensation plan based on company, team, and individual success against set goals. · Health, Dental, Life &amp; Disability, FSA, HRA 401k, etc.
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.

Field Service Engineer - HPLC

<h3>Job Description</h3>
Job DescriptionDescription:
RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Manufacturing Line Engineer to work with our growing Manufacturing department as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. 
This position is located in East Windsor, NJ and is required to be onsite.
Requirements:
If this sounds interesting to you, it’s probably because up to this point you have:
<ul>
<li>Bachelor’s degree in Mechanical, Manufacturing, Industrial, Chemical, or Biomedical Engineering (Master’s preferred). </li>
<li>5+ years of experience in pharmaceutical, medical device, or high-volume regulated manufacturing environments. </li>
<li>Proven track record in equipment installation, validation (IQ/OQ/PQ), and process optimization for aseptic or solid-dose production lines. </li>
<li>Strong working knowledge of GMP, GDP, FDA, and ISO 13485 quality standards. </li>
<li>Proficiency with CAD software (SolidWorks, AutoCAD) for production line design and modification. </li>
<li>Experience with automation systems (PLCs, robotics, HMI, and machine vision inspection). </li>
<li>Familiarity with process and cleaning validation, change control systems. </li>
<li>Working knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies. </li>
<li>Strong communication and cross-functional collaboration skills, including documentation and technical writing for regulatory compliance. </li>
</ul>
The main expectations and responsibilities for this position are:
<ul>
<li>Provide technical support for manufacturing lines, ensuring reliable operation, GMP compliance, and minimal downtime. </li>
<li>Lead equipment qualification (IQ/OQ/PQ) and process validation activities for new or modified equipment. </li>
<li>Perform process monitoring and data analysis to identify performance trends and drive continuous improvement. </li>
<li>Conduct technical review of batch records and support investigations of deviations or non-conformances. </li>
<li>Implement process and technology enhancements to improve efficiency, quality, and safety. </li>
<li>Support change control and audit readiness in collaboration with Quality and Validation teams. </li>
</ul>
 
If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation.
We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Manufacturing Line Engineer

<h3>Job Description</h3>
Job Description
Position: Product Quality Engineer (PQE) – Medical Device Manufacturing
Shift: 8:00am to 5:00pm
Location: Ft Worth, TX(remote/hybrid) 
Travel: 25% - 50% (including some international travel) 
Reports to: Sr. Director of Quality and Regulatory
Company Overview
Precision Monitoring is a leading innovator in healthcare diagnostics, offering remote monitoring and enterprise management solutions that drive better outcomes across the healthcare continuum. We specialize in Holter, Event, and Telemetry monitoring systems that simplify complex workflows for providers operating in a highly regulated environment.
Our culture promotes analytical thinking, innovation, and a commitment to excellence. As we continue to expand, we’re seeking passionate professionals who bring energy, integrity, and a results-driven mindset to join our growing team. We offer competitive compensation, comprehensive medical benefits, and a collaborative work environment.
Position Summary
We are seeking a Product Quality Engineer (PQE) to lead product quality assurance, manufacturing readiness, and supplier management and coordination efforts for its FDA-regulated cardiac monitoring systems. This role serves as a critical bridge between engineering, quality, and manufacturing, ensuring that all products meet regulatory, performance, and reliability standards. The PQE will also dedicate approximately 25% of their time managing supply chain and contract manufacturing partners to maintain quality alignment and operational continuity.
Key Responsibilities:
<ul>
<li>Product Quality &amp; Compliance (Core ~75%)</li>
<li>Supply Chain &amp; Contract Manufacturing (~25%)</li>
</ul>
Essential Functions:
Product Quality &amp; Compliance (Core ~75%)
<ul>
<li>Lead product quality engineering activities for remote cardiac monitoring devices (Pods, Gateways, Patches, Chargers, Batteries).</li>
<li>Manage nonconformances (NCR), corrective and preventive actions (CAPA), supplier deviation reports, and failure analyses.</li>
<li>Support design and development activities related to UDI labeling requirements and ensure accurate and timely submission of UDI data to the FDA database (GUDID).</li>
<li>Support and improve quality system documentation ensuring continued compliance to FDA 21 CFR 820 and ISO 13485:2016 requirements.</li>
<li>Conduct First Article Inspections (FAI) and Design/Process Validation (IQ/OQ/PQ) for new and transferred products. Ensure the products Master Validation file is maintained.</li>
<li>Partner with R&amp;D to ensure design inputs, risk management (ISO 14971), and verification/validation protocols align with quality standards.</li>
<li>Review Device History Records (DHRs), Device Master Records (DMRs), and inspection plans for completeness and compliance.</li>
<li>Analyze product returns (RMAs), field failures (Complaints), and yield metrics to identify trend, open CAPAs related to trends identified and drive root cause corrective actions.</li>
</ul>
Supply Chain &amp; Contract Manufacturing (~25%)
<ul>
<li>Coordinate with key manufacturing partners (ClearPath, Sigmatronix, Plastikon, Social Mobile, PHD Battery, SGA) on product quality, supplier performance, and audit readiness. </li>
<li>Provide oversight of supplier CAPAs and audit response closure.</li>
<li>Implement improvements and oversee incoming inspection criteria, supplier scorecards, and supplier quality agreements.</li>
<li>Collaborate with Operations to manage build readiness and ensure consistent delivery schedules.</li>
</ul>
Continuous Improvement
<ul>
<li>Identify and lead process improvement initiatives to reduce defects and optimize yields.</li>
<li>Drive supplier and internal quality metrics (FPY, DPPM, OTD, RMA) tracking and reporting. Including performing trend analysis for Management Review reporting.</li>
<li>Contribute to Lean/Six Sigma and risk-based quality programs supporting scalability.</li>
</ul>
Qualifications
Required Qualifications
<ul>
<li>5–8 years of experience in medical device quality engineering, ideally in Class II or III devices. </li>
<li>Demonstrated expertise in quality systems, supplier quality, product development, and manufacturing liaison roles.</li>
<li>Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 (Risk Management).</li>
<li>Proficient in CAPA, NCMR/NCR, UDI-DI, validation protocols, and documentation control systems.</li>
<li>Familiarity with ERP/MRP tools (e.g., NetSuite, Arena, or equivalent).</li>
<li>Strong communication, analytical, project coordination, and problem-solving skills.</li>
<li>Bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, or related).</li>
<li>Ability to travel 25% to 50% </li>
<li>Ability to travel International as needed</li>
</ul>
Preferred Qualifications
<ul>
<li>Experience in electronic and mechanical subassembly manufacturing.</li>
<li>Familiarity with DFM/DFX principles and supplier transfer validation.</li>
<li>Six Sigma Green Belt or equivalent certification.</li>
<li>Hands-on experience supporting global suppliers or CMOs.</li>
<li>Comfortable working with KPIs and performance-based metrics.</li>
<li>Ability to accept and apply constructive feedback with professionalism.</li>
<li>Demonstrated accountability and ownership of outcomes.</li>
</ul>
Success in This Role Means
<ul>
<li>Sustained product compliance and supplier performance across all contract manufacturers.</li>
<li>Reduction in field failures and nonconformances through proactive quality engineering.</li>
<li>Consistent readiness for FDA and ISO audits.</li>
<li>Effective coordination between Quality, Engineering, Manufacturing, and Supply Chain teams.</li>
<li>Demonstrated ownership of product reliability and supplier quality outcomes.</li>
</ul>

Opportunity Statement
Precision Monitoring is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate based on race, color, religion, gender, national origin, age, disability, genetics, veteran status, sexual orientation, or any other protected characteristic under applicable law. This policy applies to all employment practices including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Product Quality Engineer

<h3>Job Description</h3>
Job Description
Position Title:&nbsp;ISE I- Boston, MA&nbsp;
Salary:&nbsp;$88,000- $120,000/yr
Other Forms of Compensation:
Join Intelas, a Compass One Healthcare company.
 Intelas, a Compass One Healthcare company, delivers smarter asset management by blending expert service teams with intelligent, data-driven strategies that help hospitals improve uptime, simplify oversight, and make more informed capital decisions. Our programs support 100% regulatory compliance and drives 98% equipment uptime—so clinicians can focus on care, not equipment issues.
 We support nearly 4,500 healthcare sites nationwide—from large, campus-based acute care hospitals to system-integrated outpatient clinics. With more than 1.15 million medical devices managed, we provide the clarity and consistency needed in today’s rapidly evolving healthcare environment.
 Join Intelas—where your career thrives, your potential is unleashed, and your work directly supports patient care. Whether you're just starting out or are a seasoned professional, our people-first approach ensures opportunities for continuous growth, development, and fulfillment.&nbsp;
 Explore more at intelashealth.com.
Job Summary
Key Responsibilities:
<ul>
<li>Perform planned preventive maintenance, calibrations where certification may be required and electrical safety inspections on imaging and related equipment in compliance with established standards</li>
<li>Perform major repairs by replacing defective components, readjust components to manufacturer’s specifications using appropriate tools and measuring instruments. May require certification in order to complete repairs</li>
<li>Assist with diagnostic imaging cross training of BMET Technicians</li>
<li>Confers with manufacturer’s representatives and equipment operators to resolve equipment related problems</li>
<li>Provide emergency on-call responsibilities</li>
<li>Research and initiate orders for repair parts, working within established budget parameters</li>
<li>Conducts and compiles Quality Assurance records and reports necessary for compliance with specifications and policies</li>
<li>Document all significant asset related actions in compliance with department practices</li>
<li>Must be capable of performing all the duties and responsibilities of a BMET III</li>
</ul>
Preferred Qualifications:
<ul>
<li>Associates degree in Electronics/Imaging Technology, Biomedical Equipment Technology, or military training</li>
<li>Prior experience of at least 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, MRI, nuclear medicine, ultrasound, CT, cath. lab., linear accelerators, etc. </li>
<li>Prefer certification (CRES) in these different modalities</li>
<li>Good communication and strong customer service skills</li>
<li>Ability and willingness to serve "on-call" duty as required</li>
<li>Must be willing to serve as a technical resource to others in areas of specialty or certification(s)</li>
</ul>
Apply to Intelas today!
 Intelas is a member of Compass Group USA
 Click here to Learn More about the Compass Story
Associates at Intelas are offered many fantastic benefits.&nbsp;
•&nbsp;&nbsp; &nbsp;Medical •&nbsp;&nbsp; &nbsp;Dental •&nbsp;&nbsp; &nbsp;Vision •&nbsp;&nbsp; &nbsp;Life Insurance/ AD •&nbsp;&nbsp; &nbsp;Disability Insurance •&nbsp;&nbsp; &nbsp;Retirement Plan •&nbsp;&nbsp; &nbsp;Flexible Time Off •&nbsp;&nbsp; &nbsp;Holiday Time Off (varies by site/state) •&nbsp;&nbsp; &nbsp;Associate Shopping Program •&nbsp;&nbsp; &nbsp;Health and Wellness Programs •&nbsp;&nbsp; &nbsp;Discount Marketplace •&nbsp;&nbsp; &nbsp;Identity Theft Protection •&nbsp;&nbsp; &nbsp;Pet Insurance •&nbsp;&nbsp; &nbsp;Commuter Benefits •&nbsp;&nbsp; &nbsp;Employee Assistance Program •&nbsp;&nbsp; &nbsp;Flexible Spending Accounts (FSAs) •&nbsp;&nbsp; &nbsp;Paid Parental Leave •&nbsp;&nbsp; &nbsp;Personal Leave
 Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws.&nbsp;For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information.&nbsp;
 Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.
 Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.
Applications are accepted on an ongoing basis.
 Intelas maintains a drug-free workplace.
Req ID: 1479741 Intelas &nbsp; ASHLEY VAVROCK &nbsp; [[req_classification]]

Imaging Service Engineer I

<h3>Job Description</h3>
Job Description
Our client in Fairfield, NJ is looking for a Senior&nbsp;Product Release Engineer for a Full time position. Pay is $110-125k annually DOE
Responsibilities:&nbsp;
<ul>
<li>Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements.</li>
<li>Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs.</li>
<li>Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.</li>
<li>Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities.</li>
<li>Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities.</li>
<li>Understand and meet Regulatory (FDA) requirements and processes for development.</li>
<li>Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&amp;R’s.</li>
<li>Oversee the creation of BOMs and initiation of the change control process (ECO) relating to Engineering documentation.</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s degree in mechanical engineering or biomedical engineering.</li>
<li>Minimum of 10 years of medical device experience.</li>
<li>Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products.&nbsp;</li>
<li>Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.&nbsp;</li>
<li>Experience in Regulatory (FDA) requirements and processes for development.</li>
</ul>
Benefits:&nbsp; The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc...&nbsp;
Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company. 
<h3>Company Description</h3>
PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Senior Product Release Engineer

<h3>Job Description</h3>
Advanced Operations Engineer
Location: Arlington, Tennessee
About Our Client:
Our client has recently merged with another highly sought after Medical Device company! They are focused on creating quality Class III implantables that will improve the lives and mobility of patients. This Fortune 500 Company is known for the culture and growth opportunity they provide their employees. Are you a top performer who is driven to be the best at what they do? This position may be just what you’re looking for!
 
Key Responsibilities:
<ul>
<li>Designing and developing new orthopedic products using CAD and CAE software to ensure precise specifications</li>
<li>Validating and testing prototypes to assess functionality, safety, and reliability</li>
<li>Collaborating with cross-functional teams to optimize designs for manufacturability and cost-efficiency</li>
<li>Reviewing material specifications and creating detailed engineering drawings for production</li>
<li>Conducting process validations and evaluating fitness-for-use testing to meet industry standards</li>
<li>Supporting manufacturing partners and contract manufacturers in integrating design improvements</li>
<li>Applying professional judgment to resolve engineering challenges during the product development lifecycle</li>
</ul>
 
Qualifications: 
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.</li>
<li>Prior experience in product development, design validation, or process validation within the medical device or orthopedics sector.</li>
<li>Proficiency with systems such as Valgenesis, OnePLM, and other related NPI (New Product Introduction) tools.</li>
<li>Prior experience with orthopedic or biologic medical devices.</li>
<li>Familiarity with the manufacturing and quality standards specific to the medical device industry.</li>
<li>Knowledge of project management principles related to product development and validation.</li>
<li>Strong understanding of product design, validation, testing, and process validation for medical devices.</li>
<li>Experience utilizing CAD (Computer Aided Design) and CAE (Computer Aided Engineering) software to model designs and produce detailed engineering drawings.</li>
<li>Ability to collaborate effectively with manufacturing partners, contract manufacturers, and cross-functional teams to optimize product designs for manufacturability.</li>
<li>NO C2C CANDIDATES</li>
</ul>
 
Interested Candidates please send your resume in WORD format to <a href="mailto:info@jblresources.com" target="_blank">info@jblresources.com</a>. 
For more information about our services and great opportunities at JBL Resources, please visit our website: <a href="http://www.jblresources.com" target="_blank">www.jblresources.com</a>.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company

Advanced Operations Engineer

<h3>Job Description</h3>
*Note: this position is only available on-site in Irvine, CA*
 
Job Summary:
The Manufacturing Engineer will play a key role in our medical technology company, which designs and manufactures innovative medical devices. This position will support the development, optimization, and validation of manufacturing processes for medical devices and consumables. The engineer will collaborate cross-functionally to scale production, improve efficiency, and ensure compliance with regulatory requirements. The ideal candidate will be hands-on, analytical, and process-driven, with a passion for lean manufacturing and continuous improvement.
The manufacturing engineer will independently support moderate complexity processes for New Product Introduction (NPI) and existing production lines, and contribute to process improvement initiatives using Lean and Six Sigma tools.
 
Duties &amp; Responsibilities:
• Develop and implement manufacturing processes for new and existing medical devices (NPI and legacy products).
• Draft and maintain work instructions, acceptance procedures, validation and technical documentation in compliance with company quality standards.
• Lead small-scale yield, efficiency, or cost-reduction projects.
• Support daily production troubleshooting and process monitoring.
• Collect and analyze production data under guidance, and communicate findings to stakeholders
• Design, develop and qualify equipment, tooling, and fixtures used in production.
• Perform equipment qualifications, process validations (IQ, OQ, PQ) and develop Master Validation Plans and Reports (VMP / VMR) ensuring robust and repeatable manufacturing operations.
• Apply Lean Manufacturing principles (5S, Value Stream Mapping, Standard Work, and Continuous Flow) to identify and eliminate waste, reduce costs, and improve workflow efficiency.
• Perform statistical analysis (e.g., SPC, Gage R&amp;R, Cpk, ANOVA, DOE) to develop, monitor and improve processes and performance.
• Conduct time studies, Root Cause Analyses (RCA), and capability studies to support data-driven decision making.
• Create and maintain Process Failure Mode and Effects Analyses (pFMEA) and assist in the development of control plans and risk mitigation strategies.
• Ensure compliance with FDA regulations (21 CFR Part 820), ISO 13485, and company-specific quality system requirements.
• Collaborate with R&amp;D, Quality, and Production teams to support design transfer, process scale-up and troubleshooting activities.
• Train production personnel on new or revised processes.
• Support continuous improvement projects and Kaizen events to enhance product quality and operational efficiency.
 
Minimum Qualifications and Experience: 
• Bachelor’s degree in Mechanical, Biomedical, Electrical, Manufacturing or Industrial Engineering (or other related field).
• 3–6 years of experience in manufacturing or process development, preferably within the medical device or a regulated industry.
• Good understanding of GMP, FDA, or ISO 13485.
• Working Knowledge of lean manufacturing tools (5S, Value Stream Mapping, Poka-Yoke, etc.).
• Proficient with process validation and quality system regulations (IQ/OQ/PQ, CAPA, NCRs).
• Experience with CAD solid modeling software (e.g., SolidWorks).
• Proficient in Microsoft Office and statistical tools (e.g., Minitab, JMP, Excel).
• Strong interpersonal, problem-solving, communication, organizational and documentation skills.
• Ability to thrive in a fast-paced, team-oriented environment.
 
Desired Qualifications:
• Proficient with 3D CAD design, preferably SolidWorks; CSWA certification or higher is highly desirable.
• Good knowledge of Design for Manufacturability (DFM), Design for Assembly (DFA), Six Sigma methodologies, and risk management tools such as pFMEA.
• Yellow Belt or Lean Manufacturing training.
• Experience with MES and ERP systems.
• Hands-On experience with specialized manufacturing processes, including soldering, adhesive bonding, laser welding, and ultrasonic welding.
Physical requirements/Work Environment 
This position is in Irvine, CA.
This position is primarily based in an office environment and involves frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may also require standing for extended periods while facilitating meetings or walking through production and facility areas. Occasional local travel is expected; therefore, the ability to operate a motor vehicle and maintain a valid driver’s license is required
The physical demands described are considered essential functions of the role. Employees must be able to perform these tasks for extended periods. Reasonable accommodations may be provided to individuals with disabilities to enable them to perform the essential functions of the position.
What We Offer
<ul>
<li>A collaborative and mission-driven workplace</li>
<li>Competitive compensation and benefits</li>
<li>Opportunities for training, growth, and career advancement</li>
<li>The opportunity to contribute directly to products that improve patient health and well-being</li>
</ul>

Manufacturing Engineer II

<h3>Job Description</h3>
The Associate Integration Engineer will be responsible for supporting the engineering and development activities of new and existing products. The ideal candidate has a fundamental understanding of manufacturing processes and possesses a high degree of professionalism and maturity.
 
Responsibilities:
<ul>
<li>Support new product launches from initial concept to launch completion, including activities for prototyping and testing, creation of technical documents and specifications, and transfer of processes to manufacturing.</li>
<li>Support creation of detailed timelines for new product introductions and follow-through on project tasks through launch completion.</li>
<li>Support development and execution Master Validation Plans and Validation Protocols/Batch Records for new/existing product lines.</li>
<li>Work independently or in support of other engineers/scientists in troubleshooting technical issues encountered during prototyping, scale-up and manufacturing of products.</li>
<li>Support preparation of Bills of Materials for new product lines and processes, working collaboratively with various groups (production, quality control, ERP) to develop cost of goods estimates.</li>
<li>Write or revise batch records and standard operating procedures to support new product introductions.</li>
<li>Work closely with cross-functional teams and make data-driven decisions to move projects forward that align with business goals.</li>
<li>Perform other related duties and responsibilities as assigned or required, including scale-up and/or process optimization of existing products.</li>
<li>Ensuring business continuity by providing support and prompt investigation and resolution of process performance drifts and CAPAs.</li>
<li>Assist with various special ad hoc projects and other duties as assigned.</li>
</ul>
 
Qualifications:
<ul>
<li>B.S. in Chemical Engineering, Mechanical Engineering, Industrial Engineering or Biomedical Engineering.</li>
<li>Ability to execute project deliverables to a schedule.</li>
<li>Ability to work within a team environment.</li>
<li>Ability to listen and clearly communicate verbally, in writing and in person to people at various levels of the organization.</li>
<li>Proficient in Microsoft Word, Excel, PowerPoint.</li>
<li>Experience with Minitab, SolidWorks, and Microsoft Project is a plus.</li>
</ul>
 
Competencies:
<ul>
<li>Determination</li>
<li>Integrity</li>
<li>Creativity</li>
<li>Collaboration</li>
<li>Moved by Urgency</li>
</ul>
 
**Regenity offers a comprehensive rewards package:**
<ul>
<li>Company performance bonus eligible</li>
<li>401(k) plan with company contribution</li>
<li>Paid time off and holidays</li>
<li>Medical, Rx, dental and vision insurance</li>
<li>Company paid life and AD&amp;D insurance</li>
<li>Wellness and Employee Assistance Program (EAP)</li>
<li>Tuition Reimbursement</li>
<li>Salary Range:$70,000-$80,000</li>
</ul>
 
Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.

Associate Integration Engineer

<h3>Job Description</h3>
A BIT ABOUT SIBEL HEALTH:
With headquarters based in Chicago, Illinois, and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best-in-class software, and novel AI/ML algorithms, all linked to the cloud. To date, we’ve launched our technologies in 20 countries, from the most advanced hospitals in the world to the most resource-constrained locations. We work with some of the most respected healthcare organizations in the world, from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.
 
THE OPPORTUNITY:
We are seeking a proactive and detail-oriented Manufacturing Process Engineer to join our dynamic operations team. In this role, you will play a critical part in scaling manufacturing processes, ensuring high quality and efficient production of our advanced medical technology products. You will work cross-functionally with R&amp;D, quality, and supply chain teams while also guiding contract manufacturing partners to translate prototypes into production-ready builds.
 
WHAT YOU WILL BE WORKING ON:
Technical Leadership &amp; Training
<ul>
<li>Act as the lead technical expert for all manufacturing processes across platforms.</li>
<li>Train and mentor technicians, ensuring effective knowledge transfer and consistent execution of processes.</li>
<li>Develop and maintain technical training programs and certification protocols for production staff.</li>
</ul>
Validation &amp; Quality Systems Ownership
<ul>
<li>Own and manage the Master Validation Plan, Process Failure Modes and Effects Analysis (PFMEA), and other key validation documents.</li>
<li>Lead and support process qualification activities (IQ/OQ/PQ) in compliance with ISO 13485, FDA, and other regulatory requirements.</li>
<li>Drive risk assessments and root cause investigations for process-related non-conformances.</li>
</ul>
Process Documentation &amp; Control
<ul>
<li>Create, revise, and control detailed build instructions, standard operating procedures (SOPs), and work instructions.</li>
<li>Maintain comprehensive documentation across all product lines to ensure consistent manufacturing practices and audit readiness.</li>
</ul>
Design for Manufacturability &amp; Test (DFM/DFT)
<ul>
<li>Collaborate with R&amp;D and test engineering teams to optimize product design for manufacturability, scalability, and testability.</li>
<li>Lead initiatives to enhance test coverage, reduce test cycle time, and improve diagnostic accuracy in both functional and in-line testing.</li>
</ul>
Continuous Improvement &amp; Root Cause Analysis
<ul>
<li>Drive production yield improvements and cost reductions through data-driven root cause analysis and structured problem-solving (e.g., 8D, DMAIC).</li>
<li>Implement Lean Manufacturing principles and Six Sigma tools to streamline workflows and reduce process variation.</li>
</ul>
New Product Introduction (NPI) &amp; Scale-Up
<ul>
<li>Serve as the bridge between product development and manufacturing, ensuring smooth transitions from pilot builds to full-scale production.</li>
<li>Develop and scale new manufacturing processes in collaboration with Contract Manufacturers (CMs), ensuring repeatability and control.</li>
<li>Oversee equipment specification, procurement, installation, and validation.</li>
</ul>
Supplier &amp; CMO Engagement
<ul>
<li>Collaborate closely with contract manufacturing organizations (CMOs) to define process requirements, resolve issues, and ensure timely product delivery.</li>
<li>Participate in supplier audits, technical reviews, and readiness assessments.</li>
</ul>
Data Analysis &amp; Reporting
<ul>
<li>Monitor process metrics (e.g., cycle time, yield, throughput) and generate regular reports to inform operational decision-making.</li>
<li>Utilize statistical process control (SPC) and other analytical tools to maintain and improve process capability.</li>
</ul>
Equipment Maintenance &amp; Calibration
<ul>
<li>Own and execute maintenance and calibration plans for all production and test equipment.</li>
<li>Ensure compliance with calibration schedules and proper documentation to meet quality and regulatory requirements.</li>
</ul>
 
ABOUT YOU:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related technical field.</li>
<li>2–5 years of hands-on experience in a regulated manufacturing environment, preferably in medical devices or electronics.</li>
<li>Strong understanding of validation methodologies, quality systems (ISO 13485, FDA QSR), and GMP requirements.</li>
<li>Experience with Lean/Six Sigma, PFMEA, and root cause methodologies.</li>
<li>Proficiency with CAD, Minitab/JMP, MES, and ERP systems is a plus.</li>
<li>Excellent communication and cross-functional collaboration skills.</li>
</ul>
Preferred Certifications (Optional but Beneficial)
<ul>
<li>Six Sigma Green Belt or Black Belt</li>
<li>Certified Manufacturing Engineer (CMfgE)</li>
<li>ASQ Certified Quality Engineer (CQE)</li>
</ul>
 
BENEFITS:
<ul>
<li>Medical, dental, vision, life, and disability insurance.</li>
<li>"Take as much time as you need" policy.</li>
<li>Simple IRA plan with employer matching.</li>
<li>Company-sponsored events and lunches.</li>
<li>Stipend for professional development.</li>
<li>Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.</li>
<li>Capability to work in a fast-paced, dynamic global environment with multiple changing priorities.</li>
</ul>
 
Sibel Health Inc.is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Manufacturing Process Engineer

<h3>Job Description</h3>
Job Summary:
The Senior Systems Engineer will lead the design, development, and integration of advanced Bluetooth Low Energy (BLE) and Radio Frequency (RF) systems for medical devices. This role collaborates with cross-functional teams to ensure high performance, reliability, and compliance with FDA and ISO standards while driving innovation in wireless medical technology.
 
Responsibilities:
<ul>
<li>Lead system design and development of BLE and RF hardware/software components for medical devices.</li>
<li>Oversee integration, characterization, and testing of wireless subsystems to ensure optimal functionality and performance.</li>
<li>Provide technical leadership and mentorship to engineering teams.</li>
<li>Manage project timelines, resources, and deliverables to meet quality and compliance standards.</li>
<li>Analyze and optimize system performance, addressing RF interference, signal integrity, and power efficiency.</li>
<li>Prepare detailed system architecture and design documentation.</li>
<li>Ensure compliance with medical device regulations and support regulatory submissions.</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelor’s or Master’s degree in Electrical, Computer, or Biomedical Engineering (or related field).</li>
<li>Minimum 5 years of systems engineering experience, including 3+ years with BLE/RF technologies.</li>
<li>Strong knowledge of RF design, BLE protocols, and medical device development processes.</li>
<li>Proficiency with RF simulation tools, embedded systems programming, and system integration.</li>
<li>Experience with IoT devices and additional wireless protocols (e.g., Wi-Fi, Zigbee).</li>
<li>Familiarity with wireless medical device standards (IEEE 11073, ISO 13485, FDA guidelines).</li>
</ul>

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