R&D Engineer II

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

The candidate will be responsible for supporting medical diagnostic instrument related (hardware, firmware, and software) development and testing activities and as well as associated engineering tasks. The candidate will work within R&D Engineering, participate in cross-functional project core teams, and interact with various departments within the organization. Additionally, the candidate will support other teams at our Meridian global sister R&D sites and businesses in line with business needs. The responsibility of R&D Engineer II position will also involve identifying challenges in R&D data backup processes, developing solutions, and presenting them to the core team. The R&D Engineer II will also work independently as a cross-functional team member for various IVD projects.

Major Duties & Responsibilities:

Support other MBI R&D sites and business units
• Prepare technical documents with RA team for 510(k) submissions
• Lead instrument and software related validation and verification projects
• Design, develop, and improve R&D instrument related workflows and SOPs
• Manage instrument and software update control process for Curian, Curian Flex, and M10 platforms
• Lead the engineering part of one or multiple New Product Development projects
• Participate at the core team level and support tasks such as:
  
  • DHF document review and management
  • Technical troubleshooting
  • Risk analysis
  • Technical documents for regulatory submissions
  • Change control
  • Instrument and software release management
• Participate and contribute as a functional point of contact to new product design and development activities, including but not limited to:
  
  • Gather user requirements
  • Develop specifications
  • Guide design of a GUI and user workflow
  • Develop software and operating manuals
  • Hardware/software issue troubleshooting, tracking, and management
• Prepare for and participate in engineering product or process design and reviews with internal R&D team members as well as global sister R&D organizations and other businesses.
• Act independently to design and author SOPs and determine necessary verification and validation test methods for automated software tools/processes, instrument hardware, software, etc.
• Provide technical updates as a knowledge resource to the R&D department and project teams for all ongoing engineering tasks.
• Participate in troubleshooting, CAPA, and quality audit activities.
• Act independently and sometimes lead in the continuous process improvement activities to reduce waste and boost organizational efficiency for the R&D department.
• Operate in accordance with the company's quality system.

Other duties as assigned:

• Ability to go up and down several flights of stairs throughout the workday in a multi-location facility.
• Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.) and adhere to applicable bio-safety practices when on the manufacturing floor.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the work shift.
• Ability to attend meetings outside of regular business hours as needed.
• Must be able to travel by car/air to other MBI locations if needed.

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor's in Biomedical Engineering, Computer Science, Electrical Engineering, Software Engineering, or equivalent; other technical degrees with strong embedded system development experience will be considered; Master's Degree preferred.
• At least 4 years professional working experience in an R&D engineering environment.
• At least 2 years of experience working at the IVD product development core team level.
• Experience in developing embedded system based (Embedded Linux, Android, or WinCE) medical instrumentation in an FDA-regulated environment is a must.

Competencies Required or preferred:

• Proficiency in programming languages (particularly C, C++, and C#).
• Comprehensive knowledge of engineering principles and concepts (particularly Electronics and Embedded Systems).
• Experience working within a QSR, IEC 62304, and/or ISO 13485 environment.
• Experience working on medical device verification and validation activities.
• Must have strong interpersonal and problem-solving skills with ability to interact effectively with all levels of the organization both internally and externally.
• Ability to work on complex development tasks - including new development, new features to existing instrument, and maintenance.
• Ability to prioritize multiple tasks from various internal and external stakeholders.
• Ability to translate business unit goals into executable plans understanding technical risks, mitigations and alternatives.
• Capacity to work from detailed specifications or from defect reports.
• Ability to clearly communicate ideas and solutions to other team members.
• Ability to independently work with external vendors and/or collaborators from sister sites for technical communications.
• Can work independently with minimal supervision; self-teaching ability is a plus.
• Must possess strong organizational skills with attention to detail to prioritize and balance workloads while meeting strict critical deadlines and performing under pressure in a fast-paced environment

Required Travel:

• None anticipated.

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*