Sr. Quality Engineer

October 22nd, 2018


HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We manufacture a transcatheter heart valve system, consisting of a catheter-based delivery system and heart valve, to treat aortic valve disease.  The procedure is performed by an interventional cardiologist / cardiac surgeon in a cardiac catheterization laboratory, and is expected to be both less invasive and less costly than an open heart valve replacement procedure.  The company currently employs approximately 100 people in Maple Grove, Minnesota.

In 2010 HLT was acquired by The Bracco Group, an international company active in the healthcare sector through Bracco Imaging. The group employs more than 3,300 employees worldwide and has annual total consolidated revenues of more than $1 billion.

HLT seeks passionate and talented people who can start contributing from day one. We want innovators seeking to advance the state of the art to improve patient outcomes.

Position Summary

Provide product quality, design assurance and expertise to product development projects.  Provide risk management throughout entire product lifecycle and assure compliance to HLT design control system.  Lead cross functional projects; assure activities are completed within prescribed schedules and efficiently utilize resources.  Identify areas of improvement, and either lead the necessary activities to completion or participate as an active member providing guidance to the team.

Provide hands-on technical quality engineering support for new product transitions internally and externally into production including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing.

Primary Duties and Responsibilities

Product Quality Engineering

  • Provide quality support for manufacturing, inspection & test activities
  • Lead product complaint investigation, analysis and final report creation
  • Conduct statistical analysis of product for the identification of trends and coordinates the implementation of necessary corrective actions
  • Review and approve document change orders (DCRs)
  • Generate inspection procedures for incoming parts and on-site production
  • Develop test methods for new specifications and/or equipment
  • Perform gauge R&R studies on test methods to assess capability
  • Generate process Failure Mode Effect Analysis (FMEA)
  • Write protocols, perform testing, and write reports for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ)
  • Evaluate new equipment and fixtures and determine their impact on validation
  • Support supplier qualifications and ongoing monitoring
  • Support activities aimed at obtaining and maintaining QSR & ISO compliance
  • Generate metrics for monitoring processes and quality system effectiveness
  • Participate in internal audits
  • Participate in the Material Review Board (MRB), reviewing and approving material disposition. Initiate, investigate and implement corrective and preventive actions (CAPA)
  • Provide quality system training

Development Projects

  • Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements
  • Provide guidance and support to the Design Control process and ensure the Design History File (DHF) is within the framework of regulatory requirements
  • Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified
  • Provide guidance and support for design verification activities
  • Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec
  • Lead risk management activities from planning, analysis and verification, and risk reporting and acceptance
  • Provide engineering expertise and support for external testing qualification such as technical standards interpretation and appropriate statistical methods, including sample size determination
  • Generate the QA deliverables to meet the project scope and plan
  • Review, provide input and approve project-related deliverables and change orders
  • Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place
  • Work with Engineering to develop production acceptance criteria, test methods, and process validation protocols
  • Review Design History Files for conformance to applicable requirements

Qualifications (Knowledge, Skills & Abilities)

Minimum:

  • BA/BS in Engineering or Science related field
  • 5+ years engineering experience
  • 3-5 years of experience in the Quality Engineering/Design Assurance capacity in the medical device industry
  • Strong working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Demonstrated knowledge and proficiency in the application of ISO 14971 and other standards related to product design and medical devices
  • Demonstrated knowledge and proficiency in quality principles and best practices
  • Moderate level of computer proficiency including MS Word, Excel, and statistical applications software
  • Effective oral and written communication skills
  • Effective technical writing skills
  • Strong leadership skills with the ability to influence without direct authority
  • Ability to work effectively with suppliers and contract manufacturers
  • Ability to lead supplier audits and overall qualifications and maintenance
  • Demonstrated knowledge and proficiency in problem solving, root-cause analysis, and corrective and preventative actions
  • Demonstrated knowledge and proficiency in statistics, data analysis and trending, and reporting of results

Preferred:

  • ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
  • Knowledge and experience with standards such as ISO 5840 Cardiovascular Implants and ISO 22442 Medical Devices utilizing Animal Tissue
  • Demonstrated knowledge of pre-market submission in U.S and Europe
  • Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments
  • Skills in other technical areas such as verification testing, sterilization validation, nitinol manufacturing and tissue processing

For further information about the position, please click here https://bit.ly/2ruyZbH