Job Title: Sr. Software Engineer - IVD
Category: Product Development
Reports to: Director of Software & Instrumentation
Type: Full Time, Immediate
Location: Ann Arbor, MI
Description/Summary: A software position is available immediately with HandyLab, Inc., Ann Arbor, MI. The successful candidate will be a member of the product development team and report to the Director of Software & Instrumentation. This position will be responsible for the development of sophisticated software for novel microfluidics based in-vitro diagnostic devices.
Key Areas of Responsibility:
- Execute software development life cycle activities, from requirements development through verification.
- Improving current system software, as well as designing and developing future software, for the diagnostic devices in compliance with all regulatory agency requirements.
- Create and maintain FDA design control documentation; assist in preparing SW portion of FDA submissions.
Qualifications and Skills:
- B.S. with 6+ years of experience in IVD industry.
- Must have direct experience in the commercial product development of a IVD or medical device.
- Working knowledge of software development lifecycle: design, development, verification & validation, and software release management and procedures.
- Must have experience developing software under FDA design control requirements and be familiar with Quality System Regulations, document control and all aspects of software quality assurance.
- Working knowledge of IEEE standards, black box testing and various test methodologies.
- Strong background in C/C++ is a must.
- Should be able to work independently with minimal direction.
- Must have excellent communication skills.
About HandyLab™
HandyLab is dedicated to the development and manufacture of novel clinical diagnostic testing products. HandyLab's proprietary products will reduce the time, cost and complexity of performing infectious disease and other testing while simultaneously improving the quality of results.
HandyLab, Inc. offers an entrepreneurial working environment and a competitive salary and benefits package featuring 401k, flexible spending accounts and medical/dental plans.
Location: Ann Arbor, MI
Start Date: Immediate
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