Getinge Remote Control Jobs in Usa
28 positions found — Page 2
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Responsible for distributing components and supplies to CADI Manufacturing. Responsible for the Inventory of all components on the CADI Manufacturing Floor. Knowledge of all related procedures.
Job Responsibilities and Essential Duties
- Distribute components and supplies to CADI Manufacturing.
- Receive components and supplies from Warehouse
- Perform all SAP transactions according to procedures.
- Inventory control and cycle counting.
- Handle chemicals and hazardous waste per procedure.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- High School Diploma or equivalent is required.
- 1 - 2 years of experience working in a cleanroom environment preferred
- Hazmat experience preferred
- Experience using SAP system preferred
- Must be able to lift 25+lbs unassisted
- Must be able to push/pull full carts and racks of components.
- May be required to stand for extended periods to perform job functions.
- Work overtime as assigned.
- Must be able to work 1st shift, 7:00AM - 3:10PM
Required Knowledge, Skills, and Abilities
- SAP or other ERP software knowledge preferred.
- Basic proficiency with Microsoft Office or equivalent software application is preferred.
Pay Rate: $21 - $24 / hour
#LI-BS1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview:
This position performs installation, maintenance, and repairs of computer driven electro-mechanical production equipment, ensuring that all related quality documentation is executed, while reviewing maintenance procedures for effectiveness.
Job Responsibilities and Essential Duties:
* Maintenance and repair of computer driven electro-mechanical manufacturing equipment in support of medical device production.
o Computer driven systems include proportional-integral-derivative (PID) operating controllers, programmable logic controllers (PLCs), and Human Machine Interface (HMI) automation.
o Sub-systems and components include electric drives, motors, electrical wiring, hydraulics, pneumatics, electrical panels, relays, printed circuit board circuitry, vacuum, and compressed air.
* Respond to emergency repair requests through troubleshooting, diagnosis, resumption of operation, and electronic documentation.
* Execute preventative/scheduled maintenance including planning of materials, parts, training, and other requirements to ensure work is executed in an efficient and timely manner.
* Document all work planned and performed in the computerized maintenance management system.
* Evaluate operation of equipment and instruments to conduct on-line adjustments. * Evaluate, quote, and order necessary replacement equipment, tools, and fixtures. * May develop or revise documents and procedures.
* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Requirements :
* A high school diploma or equivalent is required. An associate degree or equivalent years of experience in Engineering, Science or related technical field is preferred
* 1-3 years of technician experience in a manufacturing environment is required; experience working in medical device manufacturing or other FDA regulated industry preferred.
Required Knowledge, Skills, and Abilities :
* Ability to read wiring diagrams, schematics, and plumbing diagrams to expertly troubleshoot electro-mechanical equipment, electric drives, motors, basic wiring, hydraulics, and pneumatics is required.
* Working knowledge of flow controls, valve selection, and pressure regulation.
* Must demonstrate effective verbal and written communication skills.
* Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities.
* Must be flexible and demonstrate the ability to take initiative.
* Working knowledge of equipment powered by 120, 208/230, and 480VAC electrical voltage is required.
* Experience with PLC/HMI and MS-DOS programming languages is preferred.
* Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
The pay for this role is a minimum of $25 per hour ($52k/yr) and a maximum of $33 per hour ($68,640/yr).
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
This position is responsible for the research, design, development and sustainability of electronic medical equipment. This individual serves as electrical engineer in a project team. As a key member of the project team, the engineer will collaborate closely with engineers and a cross-functional team to support the full product lifecycle.
Job Responsibilities and Essential Duties
- Provide electrical technical in the research, design, development and sustainability of electronic circuits for medical devices. Ensure and maintain compliance to Corporate and Industry standards.
- Performs medical devices electrical system requirement study and functions research, participates in design & development activities, collaboration with contractors defining interface, power consumption and board dimensions.
- Programs bare metal coding for system control, performs design activities using EDA tools like OrCAD for schematics capture and PCB layout, generate circuit schematic diagrams, bills of materials and performance analyses, works with contractors for PCB fabrication and SMT, brings up PCB in the lab with tools like multimeter, oscilloscope.
- Perform system assembly, function testing, data analyzing, and test results documenting.
- Prepare documents including Design Specifications, Verification and Validation protocols/reports, relevant Risk Analysis.
- Support design reviews and contribute to risk assessments and design verification activities.
- Remote and Onsite electrical technical support as needed by the project.
Minimum Requirements
- B.S. in Electrical Engineering, M.S. preferred.
- Minimum 0-2 years related experience
Required Knowledge, Skills, and Abilities
- Deep understanding principles of DC regulators, such as LDO, Switching regulators.
- Knowledge of microcontroller hardware design and firmware coding, sensor interfaces such as SPI, I2C.
- Experience with EDA tools (OrCAD, Altium Designer, KiCAD etc.) design for schematic capture, PCB layout.
- Strong lab skills, including experience with oscilloscopes, multi-meter, and other diagnostic tools.
- Ability to work effectively in a cross-functional team environment and take direction from project leaders.
- Structured problem solving / root cause analysis.
- Ability to communicate within the discipline and with others who are not as technically trained.
- Strong oral and written communication skills
- Ability to prioritize tasks in a fast-paced environment.
- Knowledgeable using Adobe and Microsoft Office products such as Outlook, Word, Excel and PowerPoint.
- Annual Salary of 97K-107K depending on experience
#LI-JF1 #LI
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Effectively design, develop, and document medical devices and medical equipment that satisfy internal and external customer needs and business objectives.
Job Responsibilities and Essential Duties
* Interprets customer specifications to define requirements for mechanical designs.
* Performs first principal analysis related to appropriate aspects of mechanical design.
* Provide support to peers, Jr Engineers, and Co-Ops.
* Applies the 3D CAD system to create mechanical design and drawings.
* Develops detailed fabrication and assembly drawings and performs tolerance analysis.
* Develop prototypes for design evaluation.
* Troubleshoot and resolve design & processing issues.
* Contributes to details of design documentation using electronic documentation systems.
* Collects, analyzes, and interprets data to propose recommendations.
* Develops & execute design verification protocols and technical reports.
* Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies.
* Develop & debug prototype tooling / equipment and processes.
* Develop test methods and fixtures.
* Formulate plans & methods to accomplish assignments with appropriate oversight.
* Works independently and prioritizes assigned tasks with guidance.
* Contribute to project planning activities.
* Train technicians and operators on new process techniques.
Minimum Requirements
* BS in engineering discipline, mechanical preferred.
* Minimum 2-4 years related experience, or an MS and less than one year experience.
* Experience with a solid modeling CAD program, preferably SolidWorks and/or ProE.
* Experience in medical equipment / device design with experience in electromechanical, electro- pneumatic, and/or blood pumping equipment development.
* Knowledge in medical device industry regulations and practices - ISO 13485, ISO 7198 & GMP.
* Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat.
* Experience with Microsoft Visio and Microsoft Project preferred.
Required Knowledge, Skills, and Abilities
* Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software.
* Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable.
* Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable.
* Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data.
* Experience with electronic document control systems in medical device and/or medical equipment design and development.
* Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis.
* Ability to create and meet scheduled timelines (manage and coordinate tasks as required).
* Ability to work in a team environment.
* Strong communication skills.
* Competent in use of Microsoft Office tools.
* Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM's and oscilloscopes.
* Familiarity and the ability to operate basic shop equipment such as hand tools, a drill and Dremel.
* Understand and interpret simple wiring diagrams.
* Familiarity with Agile Scrum and waterfall project planning methods
This is a "Defined Term" assignment that will last approximately 6 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.
#LI-AS1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Plans and oversees engineering activities and projects within the department. Develops and directs teams to design, optimize, and implement new manufacturing processes and equipment into production. Drives continuous improvement efforts in process design, cost savings, quality improvements, and resource utilization.
Job Responsibilities and Essential Duties:
- Responsible for engineering projects, incorporating newest manufacturing technologies & methods, resolving engineering problems, and improving existing manufacturing processes/equipment.
- Responsible for upstream equipment qualification deliverables (URS, FAT, SAT, etc.).
- Prioritize and communicate project priorities based on current business needs.
- Responsible for achieving product quality, productivity, and standard cost goals.
- Maintain compliance with all regulatory standards for product and personnel safety.
- Guide, direct, and coordinate facility moves, process transfers, and new equipment installations ensuring improved product quality, manufacturing efficiencies, production yields, and reduce product costs.
- Support nonconformance investigation.
- Responsible for identification and communication with external machine builders and systems integrators.
- Support manufacturing objectives as specified by the management team by promoting investigation, inventiveness, creativity and solutions to various process, implementation, and material flow/control problems.
- Communicate new ideas, technology advances, and opportunities to management team for review, evaluation and action.
- Responsible for developing and maintaining department expense and capital budget(s).
- Create and maintain a safe environment. Ensure legal requirements and safety policies are enforced.
- Assist in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
- Ability to work with flexible and changing production schedules.
- Must be able to collaborate effectively with others, and work well within cross-functional teams and across multiple sites, as applicable.
- Self-motivated and have the ability to manage projects and problem solve on a regular basis.
- Highly organized with strong project management and technical abilities.
- Demonstrated ability to develop strategies that will help build a positive manufacturing environment.
- Ability to communicate with machine builders and system integrators.
- Strong negotiation skills required.
- Strong computer skills, including MS Office applications (Word/Excel) are required.
Minimum Requirements:
- Bachelor's degree in Engineering, Industrial Management, or related field or equivalent.
- Minimum 10 years of experience within a manufacturing or process development environment, preferably within the Medical Device Industry.
Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Duties are performed in an office/manufacturing/warehouse environment. May require the use of personal protective equipment as dictated by the work area.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The salary range for this position is between $94,000-$118,000/annually depending on experience and location, with a 5% STIP bonus
#LI-MV1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.
Are you looking for an inspiring career? You just found it.
As a Field Service Technicianfor Getinge, in our Atlanta, GA area service territory (including the Centers for Disease Control), your primary mission will be to provide maintenance and repair services at customer establishments, following manufacturer's instructions and utilizing knowledge of mechanical, hydraulic, and electronic equipment.
- You will rely on your technical expertise as an experienced field service professional to perform scheduled maintenance on a wide-array of high technical medical devices and machines.
- While performing your assigned job duties you will maintain compliance with industry regulations and requirements, regulatory body policies and protocolsand internal operating procedures and work instructions.
- Military avionics or electro-mechanical experience willbe highly considered.
- Your people skills and customer-oriented focus will be crucial in this role because you will be instructing customer personnel in the operation and proper use of the equipment.
- Additionally, your ability to juggle priorities and be flexible with your time will be critical as you respond to emergency repair requests.
Along with diverse daily challenges, we will also provide you with excellent pay, benefits, extensive training, participation in a company vehicle program, credit card and phone. Make a difference with a company that cares about what you have to contribute and clients that rely heavily on your expertise.The base salary for the position is a minimum of $34/hr and a maximum of $43/hr.
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screeningto the transplant community.
Position Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.
Primary responsibilities/authority will include:
- Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
- Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
- Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
- Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
- Design Input and Output:
- Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
- Validate that design outputs meet the specified design input requirements.
- Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
- Verification and Validation:
- Develop and execute protocols for design verification and validation strategies and acceptance criteria.
- Collaborate with testing teams to ensure thorough testing of product designs.
- Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
- Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
- Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.
Required Qualifications:
- Bachelor's degree in engineering or a related field; advanced degree preferred.
- Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
- In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
- Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
- Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
Other Requirements:
- Electrical and mechanical background strongly preferred.
- Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
- Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
- Computer proficiency in MS office (specifically Excel).
- Effective verbal and excellent technical writing skills.
- Excels at generating and maintaining organized and accurate records.
- Excellent oral and written communication skills in English.
- Able to travel domestically and internationally as required (
