Norwood, United States
about 1 year ago
The Systems Engineer will help will help the team design, develop and commercialize new Point of Care products. The talented and passionate individual will be heavily involved in hands-on integration, analysis, troubleshooting of prototype instrumentation / breadboards. The individual will also be responsible for documenting system and subsystem level components for medical diagnostic instruments.
Duties & Responsibilities:
- Demonstrates proficiency in performing root cause analysis and leading troubleshooting activities related to failure mode and error analysis of a next generation type II medical device.
- Leads the development of test plans and data acquisition in support of ongoing product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing systems HW& SW integration, software loads and updates, configuration control, and test execution and reporting.
- Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
- Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled
- Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical instrument.
- Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs.
- Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
- Perform design reviews, FMEAs, risk / hazard analysis, establish technical requirements
Knowledge & Skills:
- Minimum BS in Engineering (Biomedical or Mechanical) is required + a minimum of 8 years of relevant electromechanical medical device experience
- Ability to understand complex system interactions and the effect on analytical performance
- Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc. Expert competency with LabVIEW is a plus
- Experience in fluidics and designing small fluidic systems
- Demonstrated understanding of product development considerations for tightly controlled manufacturing processes
- Excellent understanding of medical device product development risk management methodologies
- Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)
- Surveys and investigates the requirements on the technical solution, made from various aspects (customer, law, standards, technical analysis, etc.).* Processes the requirements by analysis, structuring and documentation in transparent form, incl. corresponding sources and stakeholders.* Manages the requirements and maintains the documentation (requirements management).* May check the requirements under formal aspects regarding completeness and unambiguousness.* May check the content of requirements regarding comprehensibility, consistency, cross references, dependencies and later checkability (acceptance criteria).* May evaluate the requirements based on broad experience regarding their feasibility or contained technical risks.* May support the verification of the requirement fulfillment in the execution phase in cooperation with quality management. "Expands"Needs to consider processes and results, generated in other workflows and disciplines, implies conditions and environments, and values significance to contribute effectively to team results. Needs experienced level of analytical and distinctive conceptual skills to solve issues given, which may differ in size and nature. "Experienced Professional"These positions are expected to contribute to and deliver business processes or detailed technology solutions, in a self-managed and target oriented manner, and thus contributes to team results. Positions focusing on analyzing, developing, testing or implementing processes, technologies and systems in their specific field of expertise, from first principles. Targets are short to medium term (best to be characterized as milestones), and achievements are monitored. They may provide functional advice to and integrate services of operational staff or semi-professional colleagues. Typically these functions review to 2 to 5 years of relevant experience in their field of work and qualification. 3-5 years Thorough professional know-how in one Sub Job Family, based on practical experience and theoretical foundation. Focus on applying and expanding acquired knowledge base. Application of knowledge in broader professional context.