Sr. Design Assurance Engineer - Minneapolis - Resolution Medical

    Resolution Medical
    Resolution Medical Minneapolis

    21 hours ago

    $125,000 - $185,000 (USD) per year *
    Description

    Job Type
    Full-time
    Description
    Job Summary:
    The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
    Essential Functions:

    • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
    • Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities
    • Lead Risk Management activities from product Concept through Commercialization
    • Support design test and inspection method development, and lead method validation activities
    • Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
    • Support and ensure internal & external audit responses and on-time product re-certifications
    • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
    • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
    • Provide support for biocompatibility and sterilization qualifications
    • Develop and lead other team members and provide work direction as required
    • May have 2-3 technicians assigned for inspection, testing and project support
    • Performs other functions as required
    Requirements
    Education, Experience, and Required Skills:
    • BS Industrial Engineering, Engineering or Business Degree
    • 8-15 years of medical device experience in Quality Operations, or equivalent experience
    • 1-3 years of direct or indirect supervisory experience preferred
    • Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971
    Preferred Skills:
    • Statistical and data analysis
    • Supervisory, Solid Management and Strong Leadership experience
    Physical Requirements:
    • Prolonged periods sitting at a desk and working on a computer
    • Must be able to lift 25 pounds at times
    • Must have manual dexterity
    • Must have excellent hand-eye coordination
    • Must wear gown, gloves, and ear protection if applicable
    Summary of Benefits
    • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
    • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
    • Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
    • Flexible Time Off Program
    • Paid Parental Leave
    • Paid Holidays
    • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.
    Compensation
    • The typical base pay range for this role is between $120,000-150,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
    • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
    * This salary range is an estimation made by beBee
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