Reliability Engineer in Mounds View, MN at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

Job Description

Position Description:

This position will provide design assurance engineering (DAE) support to new product development and sustaining activities within the Extracorporeal Therapies (ECT) business unit which is a part of the Client’s Coronary and Structural Heart business. This position will provide DAE support as an extended team member on large projects or core team member on smaller projects, working closely with cross functional teams inclusive of R&D, RA, Operations, and QA Sub-team. Individual must be well rounded with a good statistical background, hands on experience with equipment, testing and test method validation activities, root cause analysis, including experience supporting CAPAs, and working knowledge of risk management to lead and participate in risk management planning, risk analysis (FMEAs). Individual must be able to multitask and work within established schedule requirements, and work in close collaboration with Design, Component Suppliers, Manufacturing, and other Quality departments.

Position Responsibilities:

  • In collaboration with Operations, QA, and R&D, support the development of new products and/or revision of existing products.
  • Lead test method validation activities related to new or revised TMs.
  • Lead and/or participate in FMEA/Risk Management activities.
  • Lead and/or participate in design verification and design validation for new products and modifications to existing products.
  • Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
  • Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
  • Work under minimal supervision. Independently determine and develop approach to solutions.
  • Contribute to the completion of specific programs and projects.
  • Anticipate roadblocks; provide direction for navigating the quality system and supporting applications.
  • Lead and support corrective and preventive actions, as necessary.
  • Provide timely updates and presentations to as applicable for process improvements, design improvements, and root cause analysis.
  • Perform standards review, and documentation of evidence of conformity.
  • May provide guidance to lower level personnel.

Basic Qualifications:

  • Education Required – Bachelor’s degree in Engineering or technical discipline
  • Years of Experience – 2+ years engineering experience (this can come from Internships)
  • Reliability Engineer experience is not required

Specialized Knowledge Required:

  • Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing
  • Experience leading risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis
  • Working knowledge of reliability analyses and test methods, including establishing relevant test parameters and sample sizes
  • Working knowledge of design verification and design validation for new products and modifications to existing products
  • Knowledge of applicable ISO standards and FDA regulations
  • GMP, QSR, ISO 13485, ISO 14971 experience
  • Ability to effectively manage multiple competing priorities
  • Strong written and verbal communication skills
  • Good interpersonal and group leadership skills
  • Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)

Desired/Preferred Qualifications:

  • Medical Device or other regulated industry experience
  • Experience with medical devices, in particular cardiac surgery devices
  • Experience with reliability testing and analysis of medical devices
  • Understanding of clinical/technical applications of cardiovascular products and human anatomy
  • Certified Quality Engineer (CQE)
  • Certified Reliability Engineer (CRE)
  • Experience with ISO 5840, IEC 62366
  • Effective negotiation, collaboration and influencing skills