Engineer – Biotech Medical Device; Lifecycle Management, Design Controls, Documentation JP

Engineer – Biotech Medical Device

Location:

Thousand Oaks CA OR Cambridge MA

Employment Type:

Contract Business Unit:
Mechanical Autoinjectors Platform Duration: 16 months with likely extensions and/or conversion to permanent Pay Rate: $40 - $46/hour W2 with benefits Notes:
Must be local - hybrid work schedule 3 onsite, 2 WFH - Urgent role to fill.

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.

Top Must Have Skill Sets:

• Device Design Controls understanding and associated experience
• Theoretical or practical experience in device failure more root cause analysis
• Good documentation skills

Key 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.
• Ens…