Senior Product Development Engineer - Medical Devices

Senior Product Development Engineer - Medical Devices

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero’s Carlsbad, CA office, we are looking for a Senior Product Development Engineer to join our mission-driven team driving innovative solutions for patients and customers. In this role you will champion the design, development, and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like ensuring high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence!

• Act as a technical lead, 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).
• Track technical risk and provide engineering guidance.
• Provide feedback and mentorship to junior engineers.
• Lead the development team through technical risk retirement. Guide 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 projects variables in order to build accurate project budgets that include feasibility, prototyping, verification and validation.
• Act as project manager for smaller, technically oriented projects.

• Able to work in the office 4 days a week
• BS in Engineering or equivalent technical degree
• 5+ years of product development experience in medical device, combination product or similar space preferred.
• Skilled at transforming complex situations into well-defined project deliverables
• Able to lead 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.
• Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs.
• Create/draft clinically relevant User Requirements with minimal oversight
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification 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
• 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)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• 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…