Senior Product Development Engineer

5 days ago

Carlsbad, United States Gilero Full time
Job Summary

We are seeking a highly skilled Senior Product Development Engineer to lead our mission-driven team at Gilero. As a key member of our team, you will be responsible for overseeing the design, development, and production of medical devices and combination devices. Your expertise will be crucial in ensuring high-quality outcomes and seamless collaboration with customers, vendors, and internal teams.

Key Responsibilities
  • Lead technical product development, increasing the rigor of technical product development, with project oversight of products, accessories, and cross-functional initiatives.
  • Manage product development deliverables of high complexity through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5).
  • Technical risk tracking, providing engineering guidance, feedback, and mentorship to junior engineers.
  • Lead the development team through technical risk retirement, guiding the team on technical risks through step-by-step simplification to discover root cause.
  • Create, review, and release documents according to Gilero's QMS and the lifecycle of the project, and develop test methods and protocols to fulfill state-of-the-art requirements.
  • Inform project managers and business development on technical project variables in order to build accurate project budgets that include feasibility, prototyping, verification, and validation.
  • Act as project manager for smaller, technically oriented projects.
  • Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs.
  • Create/draft clinically relevant User Requirements with minimal oversight.
  • Prepare documentation to support design history files and regulatory submissions.
  • Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals).
  • Support chartering and maintaining project objectives and milestones.
  • Develop testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.
  • Lead product and process risk assessments, including hazard analysis, FMEAs, and residual risk analysis in conjunction with Quality Engineering.
  • Write and execute protocols for design verification and validation.
  • Lead test method development and validation, have strong knowledge of measurement system analysis (e.g., calibration, accuracy, gage R&R, etc.).
  • Oversee and perform testing and inspection of prototypes and pre-production products, including assisting assembly for DV&V builds and clinical builds.
  • Lead investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering.
  • Investigate, evaluate, and research competitive devices and product materials/designs.
Requirements
  • BS in Engineering or equivalent technical degree.
  • 5+ years relevant experience in product development.
  • Skilled at transforming complex situations into well-defined project deliverables.
  • Able to lead a team to achieve difficult goals through step-by-step simplification.
  • Able to convert complex questions into tasks to further drive simplification and clarification.
  • Understanding of good GDP.
  • Understand the Phase Gate System.
  • Have deep ISO 14971, 13485, and CFR 21 knowledge base; experience with ISO 10993 a plus.
  • Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specifications through thought experiments and empirical testing.
  • Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approaches.
  • Ability to author scientific/logic-based rationale.
  • Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down.
  • Understanding of Pre-clinical validation and GLP.
  • Ability to review and understand technical drawings and GD&T to support development lifecycle.
  • Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc.).
  • Excellent communication skills (oral and written).
Personal Attributes

We are looking for a self-starter who is comfortable and productive in a fast-paced, entrepreneurial environment. You should be seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities, and providing high-quality service to internal and external clients. You should be committed to excellence and quality service to external and internal customers, committed to established policies and procedures, while contributing to continuous improvements.

We value collaboration, innovation, excellence, and integrity. If you are a motivated and results-driven individual who is passionate about delivering exceptional products and services, we encourage you to apply for this exciting opportunity.

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