Senior Development Quality Engineer # JN -022021-60288
Title: Senior Development Quality Engineer
Location: Little Canada, MN
Duration: 8 months contract
Primary Duties and Responsibilities:
- Lead on-time completion of Design Control deliverables
- Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
- Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
- Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis
- Support design test and inspection method development, and lead method validation activities
- Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
- Support manufacturing process development and qualification for new product commercialization and product changes
- Support internal and 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
- Support the development and review of biocompatibility and sterilization validations
- Supports R&D product builds for bench testing, animal lab, and first in human activities.
- Complete Document Change Request Reviews in a timely and objective manner
- Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
- Develop and lead other team members.
- Additional duties may be identified by functional management based on the current project/business objectives.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Bachelor’s degree within an Engineering field or related science-based discipline
- 5-8+ years of related work experience
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
- Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
- Advanced degree in a technical field
- Medical device experience, specifically with valves and /or implantable devices
- Experience working in a broader enterprise/cross-division business unit model
- Prior experience working with any or all of the following:
- ISO 13485 Medical Devices – Quality Management System
- 21 CFR Part 820 FDA Quality System Regulations
- ISO 14971 Medical Devices – Application of Risk Management
- Good Manufacturing Practices And Good Documentation Practices