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

3 Key Consulting

Job Location:

Thousand Oaks, CA - USA

Hourly Salary: $ 40 - 46

Posted: 6 August 2026 (30+ days ago)

Application Deadline: 4 November 2026

Vacancies: 1 Vacancy

Job Summary

Job Title:Engineer Biotech Medical Device (Lifecycle Management Design Controls Documentation) - (JP15650)
Location:Thousand Oaks CA OR Cambridge MA
Employment Type:Contract
Business Unit:Mechanical Autoinjectors Platform
Duration: 16 monthswith likely extensions and/or conversion to permanent
Posting Date:08/04/2026
Pay Rate:$40 - $46/hour W2 with benefits
Notes:Must be local - hybrid work schedule 3 onsite 2 WFH - Urgent role to fill.

3 Key Consulting is hiring aMedical Device Engineer Combination Products (Lifecycle Management Design Control Documentation)for a consulting engagement with our direct client a leading global biopharmaceutical company.

Job Description:
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:
1) Device Design Controls understanding and associated experience
2) Theoretical or practical experience in device failure more root cause analysis
3) 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.
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.

Preferred Qualifications and Experience
Experience in one or more of the following areas:

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.

Basic 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.

Work Environment
This position includes laboratory manufacturing and office-based activities supporting commercial combination products. Responsibilities include handling and evaluating drug delivery devices performing engineering evaluations operating laboratory equipment and supporting investigations involving prefilled syringe-based combination products in accordance with applicable safety procedures.
This is a contingent worker position supporting engineering activities within company Combination Product Engineering organization.

Why is the Position Open
Supplement additional workload on team

Day to Day Responsibilities:
Ability to 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.

Value Proposition: Unique industry opportunity career growth experience

Red Flags:

Lack of experience in the design controls process.
No ability to perform testing at ATO or AMA site
Minimal to no experience or understanding of combination products or drug delivery devices.
Bad communication skills.
Uncomfortable with a hybrid working environment.