Senior Quality Engineer

Job description (Tasks/Responsibilities):

This position is assigned to responsibilities on medium sized projects. Specifically, this individual is expected to lead the verification and validation (V&V) of electromechanical test fixtures, sustaining product changes, and process qualifications within the manufacturing environment. In addition, this individual will identify and lead / support continuous improvement activities aimed at reducing cost-of-quality and increasing overall operating efficiency within the electromechanical manufacturing enterprise.
Primary Responsibilities:
1. Develops, implements, and manages product and process V&V test protocols for both existing product changes and new product introductions into manufacturing.
2. Participates in test fixture software code reviews, definition of validation test requirements, validation testing, and reporting.
3. Utilizes quantitative methods to collect and analyze quality data, recommend potential improvements, and implement recommended solutions.
4. Understands relevant processes required to accomplish objectives.
5. Plans and manages work activities having significant technical scope with minimal direction.
6. Provides advice and mentoring to less experienced engineers or technicians
7. Communicates comfortably at all levels of the organization.

Four+ years experience with statistical techniques and quality tools (e.g. Process Flowcharting, Failure Modes and Effects Analysis, Pareto Analysis, Capability Analysis, DOE, Six Sigma DMAIC, etc.) Working knowledge of MINITAB statistical software.
5. Three or more years experience within a medical device manufacturing facility strongly preferred. Knowledge of IEC 60601-1 and ISO 13485 standards as well as FDA process validation techniques (IQ, OQ, PQ) preferred. Proven evolution of engineer’s knowledge to include real-world understanding across breadth of discipline. Proven in-depth knowledge of subtleties and pitfalls in one or more areas of expertise within a technical discipline. Proven basic knowledge of other technical disciplines. Proven ability to apply basic tools and technologies to complex problems typically involving a multidisciplinary approach. Proven ability to demonstrate analytical capabilities (including modeling, simulation, statistical analysis, analytical design tools, etc.). Working knowledge and proven skills of PC computer operating system including Microsoft office applications (Outlook, Word, Excel and PowerPoint). Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion. Proven ability to demonstrate at minimum, MEDRAD’s Team Contributor competencies: Action Oriented, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.

Education Requirements:

1. Recommended 4+ years experience and recognized as an expert within a technical discipline and significant depth in multiple technical specialties.
2. Bachelor’s Degree in Electrical or Mechanical Engineering. ASQ CQE highly preferred.

Location (City/State):

Pittsburgh, PA

Company Description:

Since 1964, MEDRAD has developed products that clinicians worldwide rely on to provide outstanding performance every time they're used. Performance that helps physicians diagnose patients more accurately and, ultimately, deliver quality patient care. You will find that same level of performance, along with the high level of customer support you've come to expect from MEDRAD, with each product and service that carries the Medrad name.