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Gilero, A Sanner Group Company · 2 days ago

Senior Product Development Engineer - Medical Devices

Carlsbad, CA

Full-time

Onsite

Senior Level

5+ years exp

Gilero, a Sanner Group Company, is an international contract engineering firm specializing in the design and development of medical devices. They are seeking a Senior Product Development Engineer to lead the design and development of innovative medical devices, focusing on product lifecycle management and technical risk mitigation.

ManufacturingMedical DevicePharmaceuticalProduct Design

Growth Opportunities

No H1B

Responsibilities

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

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

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)

Qualification

Product development experienceISO 14971 knowledgeRisk analysisDesign verificationVoice of Customer translationStatistical techniquesTechnical drawing reviewCommunicationTeam leadershipCollaborationSelf-starter

Required

Able to work in the office 4 days a week

BS in Engineering or equivalent technical degree

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

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 though 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 Engineering

Investigate, evaluate, and research competitive devices and product materials/designs

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)

Comfortable and productive in a fast-paced, entrepreneurial environment

A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clients

Commitment to excellence and quality service to external and internal customers

Follows established policies and procedures, while contributing to continuous improvements

Excellent communication skills (oral and written)