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Senior Systems Analyst

2 months ago

San Diego, California, United States Biolinq Full time

Job Overview

We are in search of a skilled and passionate technical leader to become a vital part of the Biolinq team. This role entails formulating the technical vision, orchestrating systems evaluation, and characterizing the next generation of Biolinq systems. The selected candidate will oversee technical aspects through data interpretation, development, and execution of testing methodologies. Collaboration with R&D and Operations will be essential to align bench and in-vivo data. This individual will play a crucial role in shaping long-term strategies and facilitating the transition of products into production. A proactive team player eager to advance within a rapidly evolving organization is desired.

Key Responsibilities

  • Conduct systems evaluation and characterization of Biolinq analyte monitoring systems.
  • Design and implement hypothesis-driven feasibility assessments, data analysis, and insights generation.
  • Manage extensive clinical and laboratory datasets utilizing cutting-edge techniques.
  • Examine and interpret manufacturing data and parameters, comparing them to in-vivo performance.
  • Collaborate closely with R&D, Clinical, Manufacturing, and Regulatory teams on product development, verification, and validation.
  • Facilitate feasibility assessments leading to Design Verification and assist in developing testing methodologies.
  • Engage with key stakeholders in R&D, Operations, and Quality to ensure requirements are both testable and measurable.
  • Oversee the Design Verification and Validation testing strategy, including sample sizes, acceptance criteria, and testing sequences.
  • Review design Failure Mode and Effects Analyses (dFMEAs) to ensure the implementation of appropriate design controls.
  • Train and coordinate project resources to ensure data integrity and optimize testing efficiency.
  • Proactively identify potential obstacles and implement strategies to minimize disruptions to project timelines.
  • Create documentation for gap assessments to leverage prior verification testing for design modifications.
  • Develop solutions for technical challenges using systematic problem-solving techniques and engineering best practices.
  • Investigate and resolve root causes of failures or anomalies in units.
  • Clarify test method losses and deviations from approved testing plans and protocols.
  • Collaborate with senior leadership and team members to achieve corporate objectives and key performance indicators.

Qualifications

A Bachelor's degree with a minimum of five years of relevant experience is required. A Master's degree with three years of experience is preferred.

  • 5-8 years of relevant experience in product development, system testing, and design transfer within the medical device sector.
  • Expertise in statistical analysis and data evaluation methods (t-test, ANOVA, GR&R).
  • Proficient in statistical software such as JMP and Python for analyzing large datasets.
  • Ability to take decisive actions and deliver measurable results in a dynamic, cross-functional environment.
  • Capable of distilling complex requirements into specific, measurable testing objectives.
  • Adept at navigating ambiguity and embracing new challenges.
  • Experience in building and leading teams, projects, and programs.
  • Exceptional communication and interpersonal skills, both internally and externally.
  • Experience in crafting and delivering presentations at the executive level and to customers.
  • Familiarity with FDA and ISO 13485 regulations is preferred.

Working Conditions and Travel Requirements

General office and laboratory environment.

Expected travel is less than 10%.

Physical Requirements

While performing the duties of this position, the employee is regularly required to stand, walk, sit, use hands to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, see, talk, or hear in a standard office setting. The employee may occasionally lift or move up to 15 pounds.