Job Description

Long Term Contract for a Senior Systems Engineer, Product Engineering (No corp. to corp. or 3^rd party)

WHAT YOU WILL DO:

• Sustain best-in-class medical devices through continuous design improvements, regulatory submissions, and market expansions using a broad knowledge of systems engineering, verification, and validation experience.
• Work within a cross-functional team to provide system-level expertise on fielded products, including but not limited to neurostimulation and radio-frequency (RF) ablation Class I and Class III (implantable, non-life sustaining) devices and accessories.
• Help to develop or refine customer, system, and product level requirements across a range of neuromodulation and RF ablation therapies.
• Design or revise test protocols to generate evidence for system-level verification reports and product submissions.
• Conduct feasibility studies, technology assessments, and system device characterization for existing and emerging product development.
• Executes verification and characterization testing using lab equipment such as oscilloscopes, multi-meters, power supplies, spectrum analyzers, protocol analyzers, and logic analyzers.
• Support emerging issues from fielded devices, providing research and background of interfaces, interactions, and indications based upon the device design, documentation, and product usage.
• Provide input to requirements and evidence tracing, design, process and application FMECAs, hazard analysis, and usability compliance checklists in support of the product throughout its lifecycle.
• Interface regularly with a cross-functional project team to ensure products and systems meet applicable quality and regulatory standards.
• Maintain positive and cooperative collaboration with all employees, customers, contractors, clinicians, and vendors.
• Comply with company policies, training, operating procedures, processes, and work instructions.
• Performs other related duties and responsibilities, on occasion, as assigned.

THE EDUCATION AND EXPERIENCE YOU WILL BRING:

Required

• BS Degree in biomedical, mechanical, electrical, or related physical science.
• Minimum of 7 years of relevant work experience in high reliability design with a firm understanding of device development and design controls.
• Demonstrated ability to apply understanding of systems engineering and design verification tasks to drive resolution within assigned projects.
• Demonstrated ability to effectively integrate information from varied disciplines including Design Quality, Manufacturing, Marketing, and Regulatory Affairs.
• Strong verbal and written communication ability, organizational/follow-up skills, attention to detail, and analytical skills, with demonstrated leadership capability in team settings and ability to leverage and/or engage others to accomplish projects.
• Ability to work within a team or as an individual contributor in a highly matrixed, schedule driven, geographically diverse business environment.

• Ability to travel approximately 10%, including internationally.
• Meet commitments in timely manner and maintain regular and predictable attendance.

Preferred

• Masters or Doctoral Degree in biomedical, mechanical or electrical engineering, or a biological or physical science or medicine.
• Broad level of system, board, and package experience. Demonstrated ability to work with multiple types of component/supplier specifications and trade-offs. Worked with many implementations of digital and analog systems from concept to manufacturing. Understands custom ASIC implementations and considerations on cost, power, and time to market.
• Developed fixtures for electrical testing, worked with multiple kinds of test equipment including power supplies, benchtop multimeters, oscilloscopes, spectrum analyzers, wireless protocol analyzers, network analyzers, active loads, and LCR meters. Has LabVIEW or similar test automation experience for low-volume verification or validation testing.
• Direct experience in medical implantable design, including hermetic packaging, source-selection based on FIT/MMBF data, HTOL, burn-in, and verification and validation activities. Used medical device standards such as ISO 14708-1, ISO 14708-3, ISO 60601-1, ISO 13485, IEC 62304, FDA 21 CFR 820 to drive system and product requirements. Worked with requirements tracking tools and documentation control systems, and has drafted engineering protocols and reports.
• Experience in current-source drive topologies, PWM PI control systems, BLE, titanium hermetic enclosures, nano-amp scale low power design, with a basic understanding of battery requirements for implantable medical applications.
• Publishes results in patents and trade conferences.

How to Apply

Job Types: Temporary.

223 total views, 0 today

Apply for this Job