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Diatherix - Staff/Senior Biomedical Devices Product Development Engineer

Company: HudsonAlpha
Location: Huntsville
Posted on: April 18, 2019

Job Description:

Staff/Senior Biomedical Devices Product Development Engineer This position is with Diatherix Eurofins Clinical Diagnostics which is located in the Hudson Alpha Institute, Huntsville, Alabama. Diatherix Eurofins Clinical Diagnostics is a highly-specialized laboratory providing cutting-edge molecular diagnostic testing services to hospitals and physicians using proprietary TEM-PCR (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases at high levels of sensitivity and specificity, and at very short turnaround times. The Staff/Senior Biomedical Devices Product Development Engineer supports new biomedical device product design and development activities for the Diatherix Eurofins Product & Equipment (US) Business unit. It will support design and development of new products based on Diatherix Eurofins TEM-PCR technology. This role works to originate system level requirements to be used in the development of detailed requirements for mechanical, electrical, software and other project-specific technologies. Scope will include oversight for the development, writing and execution of test protocols, reports, specifications, procedures, and evaluations following FDA and other applicable biomedical device and combination product guidelines and standards. This position will communicate with both internal and external development groups to facilitate development of robust system specifications that can be effectively tested through the design verification process. The Product Development Engineer is also instrumental in risk management activities, product verification, regulatory, and certification activities involved in marketing products. Essential Job Duties: * Accountable for leading new product development projects. Lead a cross-functional team throughout the project lifecycle, from concept to launch. Ownership of the project plan, project management, and key deliverables. * Provide design, engineering, and analysis support to other engineers and designers in the design and development of new biomedical device product. * Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements. * Create rapid prototypes with SLA or FDM and proof of concepts. * Conceptual design, detailed design, CAD modeling, prototyping, and troubleshooting. Design parts and/or systems using 3D CAD software. * Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, quality control. * Define and execute product testing and validation protocols. * Establish appropriate project plan in define tasks, dependencies, schedule and resource requirements. * Complete and approve all Design History File documentation for assigned projects as required. * Know and integrate the Quality Function Deployment method in the new product development cycle. * Know and apply the Quality System and any appropriate Federal and International standards. * Manage vendors to complete tasks according to established budgets and timelines. * Coordinate product evaluation and development with product development team and internal R&D and Clinical lab staff. * Project and resource management for defined product development projects of according to Design Control procedures. * Provide technical support as needed to complete Regulatory submissions, such as 510(k). Qualifications: * Master's degree or higher in Mechanical, Electrical, or Biomedical Engineering. * Minimum of 10 years new product design and development experience is required, biomedical design preferred * Experience working per ISO 13485 and 21 CFR Part 820, specifically as the manufacturer of record of medical devices. * Project Management Professional (PMP) certification preferred. * Working knowledge of theoretical technical principles in the following areas: mechanical drafting, Geometrical Dimensioning and Tolerance, computer aided design, engineering statics and dynamics, fluid dynamic, mechanics of materials, mechanical engineering design, materials, and technical writing. * Must possess a good understanding of manufacturing processes. Must have proven hands-on technical skills in Design for Manufacturability. * Must have experience prototyping, developing proof of concepts, and performing Design of Experiments. * Must be creative and have the ability to independently apply theoretical technical principles to product design. * Must have the ability to apply parametric solid modeling and drafting conventions to design projects. * Understanding of device product development DHF, DMR, and DHR files management and documentation requirements. * Knowledge and skills in mechanical and electronic test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management. * Must have knowledge of various software packages including Microsoft Office applications and CAD applications. * Quick study with ability to come up to speed on current projects. * Must have working knowledge of multiple engineering disciplines. * Requires some knowledge of products, technologies, and customer markets. * Demonstrated ability to methodically investigate, determine solutions and resolve complex problems using current and new technologies. * Project management including planning, execution, budgetary constraints. * Must be able to manage and resolve conflicting product and project requirements. * Ability to interface effectively with customers, subordinates, peers, subcontractors, and vendors. * Must be able to operate with minimal supervision in a manner consistent with divisional and corporate goals. * Must have excellent interpersonal skills and must be able to work effectively in a team environment. * Must have excellent verbal & written communication skills. * Excellent time management and organizational skills. We Offer: * Competitive Salary * Medical, Dental & Vision Insurance * Short and Long Term Disability * Life Insurance * Dependent Care Flex Spending Account * Voluntary Policies (Accident, Hospital Indemnity, Critical Illness & Supplemental STD) * 401(k) Plan * Paid Vacation & Holiday Diatherix is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.SDL2017

Keywords: HudsonAlpha, Huntsville , Diatherix - Staff/Senior Biomedical Devices Product Development Engineer, Engineering , Huntsville, Alabama

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