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    Design Assurance Manager - Minneapolis, United States - VitalPath

    VitalPath
    VitalPath Minneapolis, United States

    2 weeks ago

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    Description

    Job Description

    Join VitalPath in New Hope as a Design Assurance Manager

    VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We're excited about this significant work and bring vital energy to our customer partnerships. In our growing organization, we aim to maintain a small-company, family-oriented environment with competitive pay and benefits. If you are passionate about making a positive impact in people's lives and being part of a welcoming and engaging workplace that values diversity, consider joining our team.

    About the Position

    The Design Assurance Manager oversees all quality and compliance aspects of the New Product Development System. Responsibilities include ensuring that medical devices' design and development align with regulatory standards and quality requirements. This role entails leading design assurance activities such as risk management, design verification and validation, and ensuring adherence to design controls throughout the product lifecycle. Additionally, this position provides overall leadership for the site's quality initiatives and oversees all aspects of its Quality System while serving as the site's Management Representative.

    Responsibilities

    • Lead design assurance activities for new product development projects to ensure compliance with FDA, ISO, and other regulatory standards.
    • Develop, implement, and maintain design control procedures for robust product design and development processes.
    • Oversee risk management activities, including developing and maintaining risk management files.
    • Coordinate design verification and validation activities, including protocol development and reporting.
    • Review and approve design control documentation.
    • Collaborate with cross-functional teams to integrate design assurance activities seamlessly.
    • Lead design reviews to ensure compliance with regulatory requirements.
    • Monitor and analyze design and development trends for continuous improvement.
    • Provide training on design assurance principles and practices.

    Requirements

    • Bachelor of Science (BS) in Mechanical, Manufacturing, or Quality Engineering
    • 7 years in quality leadership roles with people management experience
    • Minimum of 5 years in design assurance or related roles in the medical device industry
    • Strong leadership skills to influence and coach at all organizational levels
    • Experience in various Quality areas, including Inspection, Complaints, CAPA, MRB
    • Experience with ISO13485:2016 or related standards maintenance
    • Strong communication skills and process-oriented mindset for delivering results
    • Experience in Risk Management processes and methodologies
    • Proven experience in design controls, risk management, and verification/validation
    • Strong analytical and problem-solving skills with the ability to manage multiple projects
    • Excellent communication and interpersonal skills
    • Ability to travel occasionally to other VitalPath locations
    • Participation in conferences and meetings for extended periods

    Preferred Skills & Experience

    • Masters of Science in Engineering or MBA
    • 5-7 years leading cross-functional teams on quality standards
    • 7-10 years in Quality Engineering and management in the medical device industry
    • Experience in improving quality processes to comply with standards and regulations
    • Certification as a Lead Auditor for ISO 13485:2016
    • Certification in Quality Engineering or related certifications
    • Experience with lean manufacturing systems and design transfer activities

    Benefits

    • Comprehensive Health and Dental Insurance Plans
    • Vision Insurance
    • Health Savings Account with company contribution
    • Short and Long Term Disability
    • Supplemental insurances such as life insurance
    • Paid Time Off and Holidays
    • 401K with company match
    • Competitive compensation and opportunities for career growth
    VitalPath is committed to diversity and is an Equal Opportunity Employer. All qualified applicants will be considered without discrimination based on various factors. VitalPath also participates in E-Verify.
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