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.

Other Duties:

• 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

Required Qualifications:

• 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.

Preferred Qualifications:

• 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
• EUMDR
• MDSAP
• Good Manufacturing Practices And Good Documentation Practices