Senior Design Assurance Engineer
3 weeks ago
Nextern is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.DUTIES AND RESPONSIBILITIES:· Lead the design assurance activities and support product development through design verification and validation.· Develop and execute risk management and design control documents, including DHF, DMR, and technical files.· Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.· Analyze testing data and prepare technical documentation for submissions to regulatory bodies.· Oversee design reviews and provide constructive feedback to team members.· Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.QUALIFICATIONS:· Bachelor’s Degree in Engineering or a related field; Master’s preferred.· Minimum of 5 years of experience in design assurance within the medical device industry.· In-depth understanding of design control and risk management principles.· Proven experience with FDA, ISO, and IEC regulations and standards.· Proficient in statistical analysis software and methodologies.· Strong communication skills and ability to work collaboratively in cross-functional teams.· Demonstrated problem-solving abilities and attention to detail.Nextern offers excellent benefits to fuel you in building a fulfilling life & career:Employer subsidized health insurance for employeesEmployer paid dental insuranceEmployer HSA contribution401k plan with a company match9 paid holidays (including your birthday) + PTO and Personal daysGym membership subsidyEmployee Short Term Disability, Long Term Disability, and AD&D Life InsuranceThe pay range for this position is $100,000 - $125,000.Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr
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Senior Design Assurance Engineer
1 week ago
Maple Grove, United States Konik Full timeSenior Design Assurance EngineerMaple Grove, MN | Direct-Hire | $105,000–$135,000 | OnsiteKonik is working with a medical device client who is seeking a Senior Design Assurance Engineer to provide technical leadership and ensure that new and existing medical device designs meet the highest standards of quality, safety, and regulatory compliance. This role...
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Senior Design Assurance Engineer
6 days ago
Maple Grove, MN, United States Nextern Inc. Full timeNextern is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance. DUTIES AND...
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Senior Software Design Assurance Engineer
2 weeks ago
Maple Grove, United States Boston Scientific Full timeSenior Software Design Assurance Engineer This is an exciting opportunity for a software focused Senior Design Assurance Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high...
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Senior Software Design Assurance Engineer
6 days ago
Maple Grove, United States Boston Scientific Full timeSenior Software Design Assurance Engineer This is an exciting opportunity for a software focused Senior Design Assurance Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high...
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Senior Software Design Assurance Engineer
7 days ago
Maple Grove, United States Boston Scientific Gruppe Full timeSenior Software Design Assurance Engineer Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance Boston Scientific offers an exciting opportunity for a Senior Design Assurance Engineer to support a cross?functional team in the development and...
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Maple Grove, United States Nextern Full timeA leading medical device company in Maple Grove is seeking a Senior Design Assurance Engineer. This role includes ensuring product designs meet quality standards and involves leading design assurance activities, developing risk management documents, and collaborating with cross-functional teams. An ideal candidate has at least 5 years of experience, a...
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Senior Software Design Assurance Engineer
3 days ago
Maple Grove, United States Boston Scientific Full timeAbout the role: This is an exciting opportunity for a software focused Senior Design Assurance Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high visibility which will...
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Senior Software Design Assurance Engineer
4 days ago
Maple Grove, United States Boston Scientific Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
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Principal Design Assurance Engineer
2 weeks ago
Maple Grove, United States Konik Full timePrincipal Design Assurance EngineerMaple Grove, MN | Direct-Hire | $140,000–$160,000 | OnsiteWe are seeking a Principal Design Assurance Engineer to provide strategic and technical leadership in ensuring that medical device designs meet all applicable quality, safety, and regulatory requirements. This individual will serve as a subject matter expert in...
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Principal Design Assurance Engineer
6 days ago
Maple Grove, MN, United States Konik Inc Full timePrincipal Design Assurance Engineer Maple Grove, MN | Direct-Hire | $140,000–$160,000 | Onsite We are seeking a Principal Design Assurance Engineer to provide strategic and technical leadership in ensuring that medical device designs meet all applicable quality, safety, and regulatory requirements. This individual will serve as a subject matter expert in...
