... Senior Innovation Engineer, Packaging Development at our Pharma, Health & Durables Site in ... validate high barrier sustainable packaging solutions for pharma and medical device products.
... Senior Innovation Engineer, Packaging Development at our Pharma, Health & Durables Site in ... validate high barrier sustainable packaging solutions for pharma and medical device products.
System Test and Validation Lead
Richmond, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Richmond, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Mclean, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Mclean, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Rosslyn, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Richmond, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Richmond, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Mclean, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
System Test and Validation Lead
Mclean, VA · On-site +1
... science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical
Manufacturing Engineer
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Manufacturing Engineer
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Manufacturing Engineer
Blacksburg, VA · On-site
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Manufacturing Engineer
Blacksburg, VA · On-site
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Manufacturing Engineer
Blacksburg, VA · On-site
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Manufacturing Engineer
Blacksburg, VA · On-site
$64K - $82K/yr
... Master Validation Plans * Maintain compliance with medical device quality system including ... Programming skills is a plus * Experience in an ISO 13485, ISO 9001, or medical device ...
Bachelor's or higher degree in a discipline relevant to the medical device industry. This may includeelectronic/electrical,electro-mechanical or biomedical engineering or medical physics.
Bachelor's or higher degree in a discipline relevant to the medical device industry. This may includeelectronic/electrical,electro-mechanical or biomedical engineering or medical physics.
Bachelor's or higher degree in a discipline relevant to the medical device industry. This may includeelectronic/electrical,electro-mechanical or biomedical engineering or medical physics.
Bachelor's or higher degree in a discipline relevant to the medical device industry. This may includeelectronic/electrical,electro-mechanical or biomedical engineering or medical physics.
Principal Automation Engineer
Staunton, VA · On-site
$122K - $169K/yr
Together, Advancing Patient Outcomes At Cadence, we are a Medical Device Contract Development and ... Support equipment design, procurement, installation, validation, and production readiness ...
Quick apply
Principal Automation Engineer
Staunton, VA · On-site
$122K - $169K/yr
Together, Advancing Patient Outcomes At Cadence, we are a Medical Device Contract Development and ... Support equipment design, procurement, installation, validation, and production readiness ...
Principal Automation Engineer
Staunton, VA · On-site
$122K - $169K/yr
Together, Advancing Patient Outcomes At Cadence, we are a Medical Device Contract Development and ... Support equipment design, procurement, installation, validation, and production readiness ...
Quick apply
Principal Automation Engineer
Staunton, VA · On-site
$122K - $169K/yr
Together, Advancing Patient Outcomes At Cadence, we are a Medical Device Contract Development and ... Support equipment design, procurement, installation, validation, and production readiness ...
... including medical device components. The ideal candidate will have hands-on experience in a ... Provide corrective actions to fix tooling to minimize downtimes Conduct process validation ...
... including medical device components. The ideal candidate will have hands-on experience in a ... Provide corrective actions to fix tooling to minimize downtimes Conduct process validation ...
... including medical device components. The ideal candidate will have hands-on experience in a ... Conduct process validation activities including writing and executing IQ/OQ/PQ Improves ...
... including medical device components. The ideal candidate will have hands-on experience in a ... Conduct process validation activities including writing and executing IQ/OQ/PQ Improves ...
Quality Engineer II
Salem, VA · On-site
$69K - $90K/yr
... to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients ... You will Lead the generation and completion of protocols and reports for test method validations.
Quality Engineer II
Salem, VA · On-site
$69K - $90K/yr
... to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients ... You will Lead the generation and completion of protocols and reports for test method validations.
Quality Engineer II
Salem, VA · On-site
$69K - $90K/yr
... to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients ... You will Lead the generation and completion of protocols and reports for test method validations.
Quality Engineer II
Salem, VA · On-site
$69K - $90K/yr
... to Medical Device OEM's (original equipment manufacturers) to enhance the lives of patients ... You will Lead the generation and completion of protocols and reports for test method validations.
Medical Device Validation Engineer information
What are some common challenges faced by medical device validation engineers during the validation process?
Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.
What does a medical device validation engineer do?
A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.
Are medical device validation engineers in demand?
Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.
What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?
| Aspect | Medical Device Validation Engineer | Quality Assurance Engineer |
|---|---|---|
| Credentials | Engineering degree, certifications like CQE or validation-specific training | Engineering or related degree, CQE or QA certifications |
| Work Environment | Design validation, process validation, testing labs | Audits, process improvements, compliance documentation |
| Industry Usage | Product development, validation phases in medical device manufacturing | Ensuring overall product quality, compliance, and process control |
The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.
What are the key skills and qualifications needed to thrive as a medical device validation engineer?
To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in Virginia? For Medical Device Validation Engineer jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Virginia look for? The top searched job categories for Medical Device Validation Engineer jobs in Virginia are:
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What cities in Virginia are hiring for Medical Device Validation Engineer jobs? Cities in Virginia with the most Medical Device Validation Engineer job openings:
Other
Re-posted 6 days ago
Job description
The Company
kp is a globally recognised leader in the packaging and specialty film industry, renowned for its unwavering commitment to sustainability and innovation. The need to act on climate change has never been clearer so we incorporate sustainability into everything we do by #InvestingInBetter - creating innovative products that enhance product protection, shelf life and contribute to reducing the overall carbon footprint.
At kp, we are passionate about ensuring our customers' satisfaction, and we strive to achieve this goal by focusing all our efforts on meeting their evolving needs. Our dedication to drive a positive change in the packaging industry with a focus on quality and sustainability has earned us a reputation as a trusted partner for businesses worldwide.
kp is currently looking for a Senior Innovation Engineer, Packaging Development at our Pharma, Health & Durables Site in Charlottesville, VA who will be responsible for conceptualizing, developing, validating technically and commercially feasible high barrier sustainable packaging solutions for pharmaceutical and medical devices for global markets. The position will align with kp's short and long term strategic goals and work with internal and external stakeholders to design and develop packaging solutions by collaborating with global innovation and cross functional teams.
Tasks & Responsibilities:
- Understand market/customer requirements to design, develop and validate high barrier sustainable packaging solutions for pharma and medical device products.
- Construct design brief in close coordination with sales, product line management, quality, manufacturing and regulatory to define product CTQs and CTPs
- Lead packaging development projects from concept to commercialization using kp's stage gate process and present stage gate updates to peers and kp's senior leadership team
- Work in close collaboration with global innovation team members to develop kp's short and long term strategic platform solutions.
- Develop packaging solutions which meet with global pharma and medical device regulatory requirements.
- Work with kp's external partners to develop open innovation and joint solutions that meet with customer and market expectations.
- Use quality by design (QBD) methodologies to develop robust solutions which would meet with pre-defined critical to quality (CTQ's) and critical to process (CTP's).
- Write timely and detailed but succinct reports to bring out the project goals, actions, observations and next steps
- Domain expertise in pharma packaging/medical packaging
- Demonstrated ability to work with process and production engineers to understand & solve real time operational challenges during product development
- Demonstrated ability to use analytical techniques such as but not limited to - DSC. TGA, FTIR
- Partner with material & technology providers to drive new innovations
- Liase with legal/patent attorneys to develop/evaluate IP/Freedom to Operate
- Monitor and drive product safety through regulatory compliances for all new products - familiarity with CONEG, PROP 65, USFDA, EC/EU, REACH etc...
Education:
Masters degree in Polymer/Chemical/Plastics Engineering, min 8 years of relevant professional experience
Knowledge/Skills:
- In depth working knowledge of polymers such as but not limited to PE,PET,PP, PETG, PCTFE, PVC, PVDC
- Hand on experience on various polymer processing techniques such as single screw/twin screw extrusion, calendaring, coating and lamination
- Subject matter expertise on structure property relationship of different polymers.
- Working knowledge of various additives for polymers such as anti oxidants, nucleating agents, anti static agents, colorants etc.
- Working knowledge of films providing oxygen and moisture barrier for protection of sensitive product such as pharma solid/liquid oral dosage.
- Domain knowledge of sterilizable medical device packaging films using various sterilizable techniques such as gamma, E Beam, EtO etc.
- Hands-on experience on extrusion/lamination/coating processes
- Good understanding of various analytical techniques such as FTIR, DSC, TGA, DMA, Microscopy
- Good understanding of various instruments such as tensile tester, impact tester, rapid prototyping.
- Proficient in Microsoft Office - Ability to Enter and Interpret Data in Excel and Write Project Reports in Word, make presentations using powerpoint.
- Ability to communicate clearly and timely with both internal and external stakeholders
- Background in Pharma/Medical Device Packaging a plus, incl. an understanding of regulatory norms for pharma and medical devices.
Competencies:
- Strong interpersonal and communication skills.
- Ability to independently engage with customers, suppliers and internal stakeholders.
- Ability to efficiently handle multiple projects at the same time.
- Ability to write succinct technical reports
- Ability to anticipate constraints and risks, design work arounds and countermeasures to achieve project objectives
- Willingness to travel occasionally for customer support, project support or training.
Apply Now!
If you are determined, thrive in a fast-paced environment with high levels of accountability and focus, then we'd love to meet you! Please apply using the link below.
At kp, Diversity, Equity and Inclusion is vital to our global success. We welcome applicants from all identities, ideas, perspectives and experiences and encourage people from underrepresented backgrounds to apply. We aim to create an inclusive culture where our employees feel empowered to play to their strengths and see themselves reflected in the organization without regard to race, gender, religion, national origin, age, veteran status, disability, sexual preference, marital status, or inclusion in any other protected class.
***Please be aware of recruitment scams. Klockner Pentaplast will never ask candidates to provide payments, bank details, national identification numbers, or any other sensitive personal information during the interview process. If you're unsure about the legitimacy of a communication claiming to be from kp, please contact us directly at career@kpfilms.com.