Design Assurance Quality Engineer II - Medical Device

Job Type Full-time Description Job Summary:

The 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:

Adheres to Resolution Medical's Core Beliefs and all safety and quality requirements Apply sound, systematic problem-solving methodologies to resolve quality issues Act as an effective team member in supporting quality disciplines, decisions, and practices Monitor field performance of recently launched and established medical devices against risk assessments Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements Partner cross-functionally to identify and support value improvement efforts to support business goals Support post market surveillance of products through competent authority communication Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs Non-Conforming Material Reports (NCMR) including root cause investigation, risk assessment, historical record review, disposition strategy, correction activities Complaints Reviews/Manufacturing Analysis including event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness Regulatory requests including certification of compliance and product inquires Change Control - lead documentation change orders per quality system requirements Risk Management - use and interpret Hazard Analysis, use/update/create Failure Modes and Effects Analysis Foster/sustain "Voice of Quality" and "Quality 1st mindset" Recommend and make changes to QMS procedures, SOPs, Work Instructions and other related documents as necessary Performs other functions as required Requirements Education, Experience, and Required Skills BS Industrial Engineering, Engineering or Business Degree and 4-7 years of medical device experience in Quality Operations, or equivalent experience preferred 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 $85,000-100,000/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.