Design Assurance Engineer

Company: ProKatchers LLC
Location: Saint Paul
Posted on: April 5, 2021

Job Description:

A global healthcare leader with a huge portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Great Environment to excel!!
Job Title: Design Assurance EngineerDuration: 08 Months contractLocation: St. Paul, MN
Job Description:Requirements:

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps in support of MDR.
• Execute and support on-time completion of Design Control Deliverables to support MDR.
• Support 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 & execution of hardware and/or systems containing software, including active cross-functional root-cause analysis investigation & resolution activities.
• Lead or support Risk Management activities from product Concept through Commercialization.
• Support design test and inspection method development, and lead method validation activities.
• Support manufacturing process development & qualification for new product commercialization and product changes.
• Support internal & external audit responses.
• Support product re-certifications.
• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
• Support execution of biocompatibility and sterilization qualifications.
• Complete Document Change Request Reviews in a timely and objective manner.
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors--Experience/Background required:
  • Experience working in a broader enterprise/cross-division medical device business unit model preferred.--Defense or other regulated businesses may be acceptable.
  • 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.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail..

Keywords: ProKatchers LLC, St. Paul , Design Assurance Engineer, Engineering , Saint Paul, Minnesota