Sr. Design Assurance Engineer - Medical Device at RESOLUTION MEDICAL LLC

Minneapolis, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

150000.0

Posted On

03 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Risk Management, Design Control, Regulatory Compliance, Statistical Analysis, Leadership, Project Management, Medical Device Experience, Cross-Functional Collaboration, Verification and Validation, DHF Compliance, Biocompatibility, Sterilization Qualifications, Root-Cause Analysis, Inspection Method Development, Component Specification

Industry

Medical Device

Description

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.

Responsibilities

The Senior Design Assurance Engineer supports medical device product development from concept through commercialization, ensuring design control deliverables and risk management activities are met. They are accountable for quality plans, design verification and validation, and maintaining DHF compliance.