Medical Equipment / Devices
Engineering – Systems
Location: Eastern Massachusetts
7+ to 10 years of experience
Management Experience Required – No
Minimum Education – Bachelor’s Degree
Job Function Summary:
Translates customer needs into software technical requirements supporting product research, design, life cycle management, and/or product and systems development/ integration. 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.
Key Characteristics:
- Demonstrates deep/advanced knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes, and product use to translate needs into feasible technical design requirements and recommendations. Interfaces with customers, suppliers, application users, and other technical and support personnel as necessary.
- Independently researches issues outside technical capability and selects most efficient methods/techniques to achieve objectives. Applies appropriate standards, processes, policies, procedures, practices and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s), and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
- Learns basic Patent policies, procedures, and business issues and becomes familiar with the competitive “Patent Landscape” as related to assigned work.
- Performs a variety of assignments reflecting proficiency in a broad range of complex topics; balances constraints and opportunities of 1-2 adjacent technical disciplines with primary area of specialization.
- May assist with systems architecture development at the sub-system level. Works on high impact assignments where speed, quality, and efficiency significantly impacts results.
- Performs large or complex portions of projects where responsibility includes definition, completion, technical quality, and securing consistency across assigned areas. May independently lead small technical support projects or coordinate portions of larger projects. Contributes to project strategy and approach to meet target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine best mitigation path.
- Independently solves a wide range of complex and diverse problems and evaluates short term impact of recommendations.
- Leads design reviews at the sub-system level.
- Provides technical leadership, trains, mentors, and takes initiative to assist junior staff and others. Troubleshoots complex problems, and engages others in problem solving strategies to obtain practical and effective solutions to complex issues. Evaluates applicability and impact of technical methods and solutions referred by junior staff.
- Analyzes experimental data, develops technical conclusions, and evaluates potential applicability of recommendations. Independently sets technical priorities for complex matters, when difficult compromises must be made (i.e. acts with or guides others toward the proper balance of effort vs. timeliness, and technical improvements and innovation with practical business constraints).
- Develops complex test protocols; reviews, and rejects or approves test protocols developed by others, documents/reports findings, and provides corrective guidance.
- Coordinates work primarily across project team(s), related groups, or within the department. Communicates proactively and effectively at all levels. Expands understanding and employs sensitivity in communications with culturally diverse audiences.
- Provides frequent written and oral presentations, status reports, and updates,, adapting and developing appropriate formats, presentations and content for a variety of audiences. Assists others with presentations, as requested.
Education and Experience Requirements:
- BS in Computer Science, Software Engineering, BSEE or equivalent combination of Training & Experience; & 5+ years related experience or MSE & 2+ years experience or PhD & 0-3 years related experience; real time operating systems is desirable.
- C/C++ training or experience is required.
- Intermediate to advanced level mastery of both business/technical applications.
- Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems desirable.
- Good oral, written, and technical writing skills are required.
If interested, please submit your resume to resumes@acquis.com. Thank you!
