Job Description:
Description
Essential Responsibilities and Duties
* Ensure on-time releases of new designs and existing product changes.
* Generate design plans for new product offerings as well as to enhance existing products based on new business objectives
* Design, test, troubleshoot and document product solutions to meet FDA Design Controls and other regulatory body requirements.
* Develop schematics, PCB layouts, BOMs and complete assemblies.
* Develop and maintain user manuals.
* Build & test prototypes for new product development.
* Utilize verification and validation methods to demonstrate designs meet all design requirements with particular attention given to quality and regulatory requirements.
* Support safety testing via 3rd party test facilities.
* Determine root cause for complex issues and develop practical, efficient, and permanent technical solutions.
* Create Production test fixtures, work instructions and provide the related training.
* Lead process qualification efforts to verify the manufacturability and quality of products released to Production (In-house & Contract Manufactured)
* Provide technical support to the Manufacturing and Service person.
Required Skills / Experience
* Bachelor of Science Degree in Electrical Engineering or related field
* Minimum 4 years of experience within the medical device industry with knowledge of FDA and ISO regulations.
* Excellent written and verbal communication skills. Strong technical writing skills.
* Detail oriented with solid organizational skills.
* Excellent analytical problem-solving skills
* Ability to prioritize effectively and work on concurrent projects.
* Ability to make proactive and constructive suggestions for process or product improvement.
* Ability to work both autonomously and in a collaborative team environment.
* Team player willing to take on assignments that are not always within core competency.
* Strong understanding of product design requirements of 21 CFR Part 820 and ISO 13485 for compliance with US and EU regulatory requirements.
* Capable of performing all aspects of systems engineering including concept development, architecture design and system level documentation.
* Experienced in designing precision, low current measurement and low noise analog electronics.
* Experienced in designing, debugging and supporting analog/digital circuits as well as real-time embedded electronics for both microprocessor-based, FPGA/CPLD and DSP hardware platforms.
* Solid understanding of the PCB fabrication process and proficient in using schematic diagram development tools (ORCAD/PADS), PC board layout tools (ORCAD/PADS), and simulation tools (SPICE).
* Working knowledge of fundamental PCB layout concepts especially in regards to EMC and ESD.
* Knowledge of IEC 60601 and IEC 60601-2 standards
* Knowledge in the C language as it pertains to embedded software development.
* Skilled at using oscilloscopes, Logic Analyzers, and processor emulators/debuggers.
* Proficiency with Microsoft Office Suite products, such as Word, Excel, Visio and PowerPoint.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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