Test Engineer 3

Hologic•Newark, NJ

About The Position

Designs, develops, and implements test equipment to reliably test and troubleshoot components, sub-assemblies, and systems for manufacturing. Creates test and diagnostic software programs, designs test fixtures/equipment and completes specifications and procedures for new products. The position must ensure that test equipment follows standards for good laboratory practices (GLP) and good manufacturing practices (GMP). A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments. Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Requirements

Excellent knowledge of electro-mechanical equipment, soldering and PCB design programming and testing, analog and digital electronics, and sensors
Experienced in supporting medical device manufacturing and applicable government regulations such as FDA, FAA, SEC, etc.
Excellent written and verbal communication skills.
Adapts communication style to suite different audiences.
Creates precise, accurate technical documentation.
Able to facilitate group discussions.
Strong contributor to high performing team
Advanced knowledge of MS Office, Solidworks, and programming languages such as C/C++/.net, LabVIEW/CVI, Visual Basic, and/or PLC Ladder Logic
Working knowledge of manufacturing, quality improvement and cost reduction methodologies such as CIMs, Lean, Root Cause and Root Cause Failure Analysis TQM, SPC and Six Sigma
Must follow all applicable FDA regulations and ISO requirements.

Nice To Haves

College Degree
Technical Bachelor’s Degree
5-8 Years Preferred Minimum Non-Technical Degree Experience
2-5 Years with Technical Bachelor’s Degree Experience
1-3 Years with master’s degree Experience
0-1 Years with PhD Experience

Responsibilities

Owns design and development of test and validation methods for test equipment.
Write plans, procedures, and protocols for software/hardware testing activities. (verification and/or validation).
Execute verification and/or validation protocols.
Accountable for defining requirements, developing, and implementing test fixtures/equipment and corresponding specifications and procedures.
Works with contract manufacturers/vendors to resolve test failures.
Accountable for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in testing and manufacturing.
Evaluate and develop testing parameters and outputs for trending analysis.
Analyzes defects, provides feedback, and implements process improvements.
Works with R&D and monitor the system level documentation (HRS, SRS, etc) changes to ensure that system level test requirements meets Design Requirement in manufacturing, including but not limited to EMI compliance, regulatory, safety etc.
Creates and manages engineering change orders as they relate to test equipment.
Responsible for developing and leading training of assemblers, technicians and manufacturing engineers on new fixtures, equipment of procedures for production handoff.
Work closely with and contribute to cross functional teams such as R&D (Electrical, Mechanical, System, Software), Quality, Manufacturing and Procurement, Supplier Quality, Other function within the Supply Chain, PMO and Strategic Sourcing.
Participates in design reviews, working with R&D and manufacturing to create a project test plan for manufacturing, define test requirements, develop test specifications, and define user interface requirements for test equipment as it relates to new product introduction.
Provide regular communication and updates on success factors such as progress, schedule, budget, project risks and resource or needs gaps.
Participates in professional development and stays current with new manufacturing test technology and processes while actively seeking to implement new technology into new and existing production lines.
Collaborates with machine/automation vendors to design, validate, and implement automated equipment/processes.
Provide mentoring and training for Test Engineers and Manufacturing Engineers.