Sr. Design Assurance Engineer - Medical Device
Resolution Medical, LLC, Fridley, MN, United States
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
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.
#J-18808-Ljbffr
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
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.
#J-18808-Ljbffr