About PhotoThera:
PhotoThera, Inc. is a medical device company whose platform technology seeks to employ penetrating near-infrared laser energy to treat a broad range of diseases and health conditions. The company is initially focused on the treatment of ischemic stroke and is engaged in a clinical study to investigate the effect of its Transcranial Laser Therapy (TLT) when used within 24 hours of the onset of stroke symptoms.
During the past twelve years, the company has invested a significant amount of scientific and engineering resources in the development of the NeuroThera® System (NTS). The NTS is an investigational device that seeks to improve neurological outcome via non-invasive delivery of transcranial laser therapy (TLT) into the brain.
Why PhotoThera:
Central to our philosophy as a Company is the desire to bring together a group of people who want to participate in the growth of a successful company, and who are proud of what they do. Our commitment is that you will be treated as an individual who can succeed in employment based on your effort, ability and performance.
In addition to a competitive salary, we believe that benefits are an important part of the package. We offer affordable medical, dental, vision and life insurance, long-term disability insurance, a 401k plan with multiple investment options, a generous paid time off program, 8 holidays per year and a flexible spending plan for medical and dependent care costs. Please visit our website, for more information: http://www.photothera.com/
PhotoThera is proud to be an Equal Opportunity Employer committed to hiring a diverse work team.
Positions Available:
Sr. Software Engineer
The Sr. Software Engineer will design and develop software within a small multidisciplinary project team for laser based, Class III, medical devices for PMA submission to the FDA.
Essential Duties and Responsibilities include the following:
- Design and develop software for a laser based, Class III, medical device for PMA submission in a multidisciplinary project team.
- Design and write complex software including GUI software and real time embedded microcontroller code.
- Create software unit test and integration plans for software development and verification that ensures compliance with internal standards and global regulations.
- Generate product development documentation (e.g. unit test plans, integration testing plans, requirements, specifications, code, version control, verification, risk management file, design history file, etc.)
- Lead or participate in design reviews, thoroughly assessing the ability of proposed designs to meet specified requirements.
- Interact closely with systems, mechanical and electrical engineering functions to develop comprehensive solutions to design problems.
- Analyze designs to predict system performance under all operating conditions and failure modes
- Document designs for Design History Files and Device Master Records.
- Contribute to manufacturing process development to ensure manufactured devices will meet specification.
- Ability to author clear and technically accurate reports as well as presentations.
- Ability to complete assigned deliverables in compliance with quality system requirements.
Education and/or Experience:
- Bachelor of Science Degree.
- 10+ years of experience in a medical device environment or similarly regulated industry preferred.
- C, C++, microprocessor/controller based hardware and software platform development, Window CE development.
- Working knowledge of FDA quality systems requirements preferred.
- High to Intermediate skill level in Microsoft applications preferred (Word, Excel, PowerPoint, Visio).
Please send your resume and cover letter to:
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Mechanical Engineer
We are looking for a Mechanical Engineer to join our team!
Essential Duties and Responsibilities include the following:
- Responsible for mechanical design elements of medical laser systems, accessories, labeling and packaging.
- Evaluates design solutions via simulations and prototype testing.
- Verifies that designs meet specification.
- Ability to author clear and technically accurate reports.
- Ability to present technical information to the design team.
- Contributes to the development of manufacturing documentation.
- Completes assigned deliverables in compliance with quality system requirements.
Education and/or Experience:
- Bachelor’s degree with emphasis in mechanical engineering.
- Solidworks experience required.
- 5+ years of mechanical design experience required.
- Must be very proficient in Microsoft applications.
- Experience developing medical laser systems for research and commercial use preferred.
- Opto-mechanical design experience preferred.
- PDMworks Enterprise experience preferred.
- Working knowledge of FDA and international quality system regulations preferred.
Please send your resume and cover letter to:
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Configuration Management Engineer
The Configuration Management Engineer is responsible for the Configuration Management (CM) environment; policy and procedure guidelines, CM planning, reporting and supporting audits, system scope change control, version control, CM documentation, and system component integration.
Essential Duties and Responsibilities include the following:
- Analyzes implementation and maintenance of Change Orders for product improvements, repairs and new product development. Guides the effective interaction between engineering, quality assurance, manufacturing, field operations and marketing to ensure all changes are documented for audit purposes.
- Develops and maintains configuration management plans in support of investigational and commercial device programs.
- Establishes the CM environment in which a system is developed and built.
- Contributes to the definition of system configuration during product development.
- Ensures control of selected and approved configuration items in order to maintain the integration, integrity, and traceability of those configuration items throughout the system or subsystem life cycle.
- Performs status reporting and manages configuration auditing.
- Provides control of systems, software and hardware as required for baseline management, system testing, integration and deployment.
- Develops and implements plans, processes, and procedures that improve and compliment the Change, Configuration and Release Management activities.
- Assists in developing and implementing plans for applying patches, upgrading versions, moving to new releases, and transitioning to replacements of the designated production software.
- Defines and implements a system for managing the hardware and software inventory.
- Supports the Change Control Board.
- Contributes to the development of Design History Files, Device Master Records, and Technical Files.
- Completes assigned deliverables in compliance with quality system requirements.
Education and/or Experience:
- Bachelor’s degree in engineering, physics or math preferred.
- 8 – 10 years of related experience.
- Experience with medical laser systems for research and commercial use preferred.
Please send your resume and cover letter to:
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.
Sr. Electrical Engineer
The Sr. Electrical Engineer will design and develop electrical systems within a small multidisciplinary project team for laser based, Class III, medical devices for PMA submission to the FDA.
Essential Duties and Responsibilities include the following:
- Responsible for the electrical design elements of medical laser systems and the corresponding accessories, labeling and packaging.
- Interacts closely with systems, software, optical and mechanical engineering functions to develop comprehensive solutions to design problems.
- Develops electrical specifications for research, investigational, and commercial devices.
- Creates schematics, selects components, develops circuit boards and designs cabling.
- Analyzes designs to predict system performance under all operating conditions and failure modes.
- Leads or participates in design reviews; thoroughly assesses the ability of a design to meet specifications.
- Documents designs for Design History Files and Device Master Records.
- Performs design verification testing to ensure designs meet specification.
- Contributes to manufacturing process development to ensure manufactured devices will meet specification.
Education and/or Experience:
- Bachelor’s degree with an emphasis in electrical engineering. Master’s Degree preferred.
- 8 + years electronics design experience.
- Experience with analog and digital design: Temperature controllers, High current monitors, ADC/DAC, USB, RS-232, I2C, Fine pitch multiple microprocessor designs with RAM/ROM, Touch panel displays.
- Working knowledge of IEC 60601-1.
- Working knowledge of FDA quality systems requirements.
- Altium Designer experience preferred.
Please send your resume and cover letter to:
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