Translates customer needs into software technical requirements supporting product research, design, life cycle management, and/or product and systems development/ integration. This position applies knowledge of multiple specialized and/or interdisciplinary technical areas, project management, and systems design and integration needs. Using current programming language and technologies, creates software components and applications to support medical device product development. Analyzes, designs, documents, programs, and debugs software programs; modifies software enhancements of existing computer programs which control the real time operation of the medical device using embedded software applications. May be responsible for the development of device drivers, application control, or user interfaces, and may design and develop algorithms for device diagnostics, communications, interactive and automated applications and/or test programs.
• Applies knowledge in a broad range of topics within technical discipline, reflecting in-depth knowledge of 1-2 sub-specialty areas. Requires project management and systems knowledge/skills, and basic business understanding. Demonstrates advanced/expert knowledge in a single or multi-disciplinary area, and balances constraints/opportunities of 2-3 adjacent technical disciplines with primary technical area(s).
• Applies solid understanding of “Patent Landscape” within specialized area(s).
• Defines key capabilities, selects, or applies standards, procedures, and tools throughout the product/system development life cycle, including Standard Operating Procedures (SOP’s), and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems. Analyzes experimental data, develops technical conclusions, and evaluates potential applicability or recommendations where ingenuity is required.
• Directs others in the creation of complex test protocols, and may work at the systems level. Prepares or contributes to the development of validation test protocols and reports (such as Clinical Test Protocols) for further committee/management review.
• Independently researches broad, diverse, complex issues outside technical capability; selects most efficient methods/techniques to achieve objectives. Simultaneously handles multiple, demanding, unstructured assignments and solves complex high impact problems requiring expert specialized skill, multi-disciplinary knowledge, and basic business understanding. Responsibility includes definition, completion, technical quality, and securing consistency across assigned area(s).
• Interfaces with customers, suppliers, application users, and other technical and support personnel, and works on a national, regional or global basis; employs appropriate communications reflecting diverse cultural sensitivity.
• May be a technical expert, lead projects or parts of complex, large, or high impact projects, or may contribute to the development of Systems Architecture, at the sub-system level, working on 2+ sub-systems. Decides project strategy/approach; sets target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine best mitigation path.
• May cover in manager’s absence, and may participate in Merger & Acquisition due diligence. Serves in an advisory role at the management or senior management level. Coordinates across groups, proactively and effectively communicating at all levels, and frequently develops, adapts, and provides written and oral presentations, status reports, and updates.
• Proposes technical solutions to resolve business issues, and evaluates short and long term impact of recommendations made independently, or proposed by staff and management.
• Provides technical leadership, trains, and mentors less senior staff to support business initiatives and strategic goals, and evaluates or troubleshoots problems referred from staff and management. Transfers knowledge/ technology solutions within or across groups.
• Serves in an advisory role at the management, or senior management level, proposing technical solutions to resolve business issues, and evaluates short and long term impact of recommendations.
• Sets technical priorities when difficult technical compromises must be made that have system level, or multiple area impact (e.g. acts with or guides others toward the proper balance of effort vs. timeliness, and technical improvements and innovations with practical business constraints). Develops policy and procedure recommendations.
• Translates customer product development needs into feasible technical design requirements and recommendations. Selects best methods and determines criteria for obtaining results; scope of analysis requires an in-depth evaluation of factors and variables not easily identified. Assignment is based on consistent innovative performance with highly complex and diverse applications.
• Works on technically complex and high impact projects and deliverables, where ingenuity and basic business understanding is required. Applies advanced/expert knowledge of specialized discipline(s) and methods, and applicability to specialized product needs to support customer, operations, and product use.
Required Bachelor's Degree In Computer Science, Software Engineering, or BSEE
Required 8 years Related experience
Required Other C/C++ training or experience
Preferred Other Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISA Quality Systems
Required Other Equivalent combination of education and experience
Licenses and Certifications:
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Related experience
Required C/C++ training or experience
Preferred Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISA Quality Systems
Required Equivalent combination of education and experience