Description
\t\t\t\t\tThe Principle, Design Assurance Engineer (PDA) is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role will be to ensure the design assurance of a heart valve and a delivery catheter system. The Principle, Design Assurance Engineer should possess a background in the medical device industry with emphasis on cardiological devices, including implantable heart valves and transcatheter delivery systems and possess a strong understanding of regulations and standards such as 21 CFR 820 and ISO 13485. Ideal candidates will have experience in a variety of functions related to design assurance, including but not limited to risk management (in accordance with ISO 14971), design verification and validation (aligned with EN ISO 5840-1/-2/-3), and quality management systems.
\t\t\t\t\tSkills
\t\t\t\t\tMedical device, Design assurance, Iso 13485, Design control, Risk management, Design validation, Validation, Quality engineering
\t\t\t\t\tTop Skills Details
\t\t\t\t\tMedical device,Design assurance,Iso 13485,Design control,Risk management,Design validation,Validation
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t-\tRequires a minimum of a Bachelor’s degree in a technical field or equivalent professional experience.-\tShould have 10 to 15 years of experience in medical device industry with 3 to 5 years experience in Quality.-\tPossess a deep understanding of ISO 13485, CE Marking, EN ISO 5840, EU MDR (formerly MDD), FDA Medical Device Regulation (MDR), and FDA requirements.-\tExtensive knowledge of manufacturing processes and practices relevant to the company’s products.-\tProficient in Microsoft Office applications including Excel, Word, and Outlook, with effective communication abilities, both oral and written.-\tMust be capable of multitasking in a dynamic, fast-paced work environment.-\tEssential to work collaboratively across all organizational levels.-\tStrong leadership skills required to manage subordinates, projects, and workflow effectively.-\tExhibits exceptional organizational skills and the ability to prioritize multiple tasks.-\tHandles confidential and sensitive information with the utmost professionalism.-\tDetail-oriented with the flexibility to adapt to the company’s evolving needs.-\tKnowledgeable in statistics, data collection, analysis, and presentation techniques.-\tExcellent interpersonal, communication, and problem-solving skills.-\tCapable of working autonomously with minimal supervision, proactively seeking guidance when necessary.-\tSkilled in defining, organizing, and managing both individual and team tasks.
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $150000.00 - $170000.00/yr.
4C Benefit Package for full time / exempt workers
Workplace Type
This is a fully onsite position in Maple Grove,MN.
Application Deadline
This position is anticipated to close on May 9, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.