Engineer – Biotech Medical Device (Lifecycle Management, Design Controls, Documentation) - (JP15650)

3 Key Consulting•Thousand Oaks, CA

7d•Hybrid

About The Position

3 Key Consulting is hiring a Medical Device Engineer – Combination Products (Lifecycle Management, Design Control, Documentation) for a consulting engagement with our direct client, a leading global biopharmaceutical company. The Engineer will support the lifecycle management (LCM) of commercial combination products, providing technical engineering support throughout the product lifecycle to ensure continued product quality, reliability, and compliance. This role partners with cross-functional teams including Manufacturing, Quality, Design Engineering, Reliability, Regulatory, and Supply Chain to investigate product performance, support product improvements, maintain design documentation, and execute Design Controls activities. The successful candidate will apply engineering fundamentals, analytical problem-solving, and technical documentation skills to support commercial products through forensic investigations, trend analysis, engineering change management, and continuous improvement initiatives. The Engineer I will also support cross-functional initiatives to sustain commercial combination products through engineering investigations, risk assessments, Design Controls, and continuous product and process improvements.

Requirements

Device Design Controls understanding and associated experience
Theoretical or practical experience in device failure more root cause analysis
Good documentation skills
Strong analytical, troubleshooting, and problem-solving skills.
Ability to perform structured root cause investigations using sound engineering methodologies.
Excellent written and verbal communication skills.
Strong technical writing skills for engineering documentation, reports, and Design Controls deliverables.
Ability to analyze complex technical data and communicate engineering conclusions effectively.
Ability to read, interpret, and apply engineering drawings, specifications, technical procedures, and applicable quality system requirements.
Strong organizational skills with the ability to manage multiple assignments and priorities in a fast-paced, regulated environment.
Ability to work independently while collaborating effectively within cross-functional teams.
High attention to detail and commitment to quality.
Comfortable working in laboratory, manufacturing, and office environments while following applicable safety procedures.

Nice To Haves

Combination products or medical device development, commercialization, or lifecycle management.
Lifecycle management (LCM) of commercial medical devices or combination products.
Mechanical system design, testing, and analysis.
Mechanical failure analysis and root cause investigations.
Product complaint investigations and forensic engineering analysis.
Experience performing computed tomography (CT) scanning, X-ray imaging, or comparable non-destructive forensic analysis techniques for medical devices or plastic injection molded components.
Experience performing forensic analysis of plastic injection molded components, including dimensional, cosmetic, structural, or material-related investigations to support root cause analysis and product performance assessments.
Assembly and disassembly of medical devices for engineering evaluation.
Engineering change control and product lifecycle documentation.
Experience supporting deviations, CAPAs, nonconformances, and engineering investigations within a regulated quality system.
Design Controls activities including feasibility, characterization, verification, validation, design transfer, and post-market support.
Development and maintenance of Design History Files (DHF) and Device Master Records (DMR).
Experience participating in Design FMEA (dFMEA), Process FMEA (pFMEA), and engineering risk assessments.
Risk management in accordance with FDA Quality System Regulation, ISO 13485, and ISO 14971 principles.
Statistical analysis and interpretation of engineering, manufacturing, laboratory, or complaint data.
Experience using statistical software such as Minitab, JMP, or equivalent for engineering and data analysis.
Familiarity with Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis, and engineering statistics.
Trend analysis using manufacturing, laboratory, or complaint data to identify product or process performance trends.
Technical documentation, engineering reports, protocols, and scientific writing.
Laboratory instrumentation and test equipment.
Mechanical testing and characterization of medical devices or plastic injection molded components.
Test method development, verification, validation, and qualification.
Prototype fabrication and mechanical evaluation.
Test fixture design and development.
SolidWorks or equivalent 3D CAD software.
Ability to interpret engineering drawings, geometric dimensioning and tolerancing (GD&T), specifications, and technical standards.
Cross-functional collaboration with Manufacturing, Quality, Regulatory, Reliability, and Design Engineering teams.

Responsibilities

Support lifecycle management activities for commercial combination products throughout their commercial lifecycle.
Perform forensic evaluation of returned, retained, and engineering samples to support technical investigations.
Assemble and disassemble combination product samples for engineering analysis, troubleshooting, and failure investigations.
Lead and support structured root cause investigations using sound engineering methodologies and cross-functional collaboration.
Manage technical trend investigations by evaluating manufacturing, laboratory, complaint, and engineering data to identify product or process trends and recommend appropriate actions.
Support engineering investigations associated with deviations, CAPAs, nonconformances, and product complaints to identify root causes and implement effective corrective and preventive actions.
Support engineering change control activities, including technical assessments, risk evaluations, documentation updates, and implementation of product and process changes.
Support product risk management activities, including risk assessments, Design FMEA (dFMEA), Process FMEA (pFMEA), and evaluation of design or process changes throughout the commercial lifecycle.
Support Design Controls activities across the product lifecycle, including feasibility, characterization, verification, validation, design transfer, and post-market engineering support.
Support development, qualification, execution, and continuous improvement of engineering test methods used for characterization, verification, validation, and commercial lifecycle investigations.
Support development and maintenance of engineering specifications, test methods, and technical standards for commercial combination products.
Author, review, and maintain technical documentation including engineering assessments, protocols, reports, specifications, test methods, risk assessments, and Design Controls deliverables.
Support the development, maintenance, and continuous improvement of Design History Files (DHF) and Device Master Records (DMR).
Collaborate with Manufacturing, Quality, Regulatory, and Operations teams to support commercial production, technical investigations, product improvements, and continuous improvement initiatives.
Apply engineering principles and statistical methods to analyze engineering, manufacturing, laboratory, and complaint data to support technical decision making, product performance assessments, and issue resolution.
Support product complaint investigations and engineering assessments to identify potential failure mechanisms and corrective actions.
Ensure engineering documentation is complete, accurate, and compliant with applicable quality system requirements and company procedures.
Support multiple commercial programs while effectively managing priorities and project timelines.
Support RCAs from rejected units from assembly site sites.
Maintenance of trend evaluations across the LCM network and ability to support LCM and some development documentation related to design controls such as verification plans and DHF maintenance.