Bachelor's degree in engineering or related field; advanced degree preferred.
1-3 years of quality engineering experience in the medical device industry.
In-depth knowledge of design control processes and quality management systems (ISO 13485, ISO 14971, FDA QSR).
Strong technical skills in product quality, including verification/validation and inspection techniques.
Understanding of regulatory requirements for medical devices (FDA, EU MDR).
Excellent communication and interpersonal skills for cross-functional collaboration.
Certifications like DFSS or DMAIC Black Belt, ASQ Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) are a plus.
Responsibilities
Implement and maintain design control processes per regulatory standards to ensure safe medical devices.
Lead risk management activities, integrating them into the design process with R&D.
Develop quality plans for new product projects, outlining objectives and validation activities.
Review and approve design inputs for clarity and regulatory alignment; validate design outputs.
Manage design changes, assessing their impact on quality and ensuring proper documentation.
Develop and execute protocols for design verification and validation, collaborating with testing teams.
Identify process improvement opportunities within the design control system.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional development and certifications.
Exposure to cutting-edge medical device technology.
Involvement in impactful projects that improve organ transportation.
Potential for domestic and international travel.
Full Job Description
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 cold 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.
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 Sustaining Engineering, 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.
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.
Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
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 (
Able to work in the US without sponsorship now or any time in the future.
US BASED SALARY - The base salary range for this role is $100,000 - $110,000 plus 5% in annual bonus.
About Atrium Medical
Atrium Medical is a medical device company that develops and manufactures products for cardiovascular, surgical, and other medical applications. The company's products include vascular grafts, endovascular stent grafts, and other devices used in cardiac and thoracic surgery. Atrium Medical was founded in 1981 and has been a subsidiary of Getinge AB since 2011.
