Resolution Medical · 2 months ago
Sr. Design Assurance Engineer - Medical Device
Fridley,MN,US
Full-time
Onsite
Senior Level, Lead/Staff
$120K/yr - $150K/yr
8+ years expResolution Medical is a company focused on medical device product development. They are seeking a Senior Design Assurance Engineer to support the development process from concept to commercialization, ensuring quality and compliance through various engineering activities.
Health CareMedical Device
Responsibilities
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
Qualification
Required
BS Industrial Engineering, Engineering or Business Degree
8-15 years of medical device experience in Quality Operations, or equivalent experience
Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971
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
Preferred
1-3 years of direct or indirect supervisory experience preferred
Statistical and data analysis
Supervisory, Solid Management and Strong Leadership experience
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
401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
Company
Resolution Medical
Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry.
201-500 employees
H1B Sponsorship
Resolution Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
BIRD Foundation
2025-10-10Grant
2021-06-02Acquired
Leadership Team
Steven Schmidt
Senior Advisor and Co-Founder of Resolution Medical
Recent News
Company data provided by crunchbase