Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) (JP15315)

3 Key Consulting

Job Location:

Thousand Oaks, CA - USA

Hourly Salary: $ 44 - 48

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Senior Device Engineer Electromechanical Combination Products (Lifecycle Management Design Control CAPA) - (JP15315)
Location: Thousand Oaks CA. 91320
Employment Type: Contract
Business Unit: Electromechanical Platform
Duration: 1 year (with likely extensions and/or conversion to permanent)
Posting Date: 04/30/26
Pay Rate: $44 - $48.50/hour W2
Notes: Only qualified candidates need apply. On site in Thousand Oaks CA. 3-5 days onsite depending on business needs. Standard hours

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

Job Description:
Ideal candidate: Seeking candidates with experience in combination products electromechanical systems or medical devices a background in pharma and hands-on expertise in design control and testing.

Our client is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Why is the Position Open
Supplement additional workload on team

Top Must Have Skills:

Lifecycle Management Experience with electromechanical platforms
Root Cause Analysis and Technical Problem Solving
Proven success in cross-functional engagement and being a team player
Nice to have: Early device development experience

Day to Day Responsibilities:

Provide ongoing lifecycle management (LCM) support for electromechanical combination products including post-market activities design improvements and cross-functional issue resolution to ensure product reliability and compliance.
Lead complaint investigations by performing detailed failure analysis identifying root causes and developing data-driven action plans in collaboration with quality manufacturing and regulatory teams.
Drive and manage quality system processes including CAPAs deviations and change controls ensuring timely closure robust documentation and alignment with regulatory and internal requirements.
Collaborate closely with external suppliers to support LCM activities including issue resolution component updates root cause analysis CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
Manage change assessments driven by internal and external changes during the life cycle of the combination product
Participate in and support cross-functional design reviews for combination product development.
Provide design verification support for combination products ensuring compliance with Quality System Requirements Design Control (21 CFR 820.30) and ISO 13485.
Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
Develop review and execute test protocols reports and technical documentation in accordance with design control and regulatory expectations.
Perform data verification analysis and traceability reviews to ensure product performance meets user needs and design inputs.
Partner cross-functionally with R&D Human Factors Quality Regulatory and Manufacturing teams to drive design robustness risk mitigation and design transfer readiness.

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Preferred Qualifications:

- Masters or Bachelors Degree in Engineering Discipline (Mechanical Biomedical Electrical) with 3-5 years (or 2 years with Masters) of professional experience in highly regulated environment (strong preference for medical device biopharma and/or combination product experience).
- Experience with electromechanical systems injection devices medical devices or delivery platforms preferred.
- Demonstrated expertise in lifecycle management data analysis and protocol/report generation under design control.
- Strong understanding of materials coordination supplier interaction and lab testing logistics.
- Proven ability to work in cross-functional project teams communicate technical results clearly and lead execution to meet program milestones.
- Working proficiency in statistical analysis software (Minitab)
- Smartsheets proficiency is a plus.
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Must be capable of working on multiple projects in a deadline driven environment.
- The position is designed for candidates at a mid-career stage with scope and responsibilities aligned to that level of experience.

Red Flags:

Unable to be consistently on-site in Thousand Oaks
Low motivation/engagement at prospect of working with medical device and/or combination products
Poor written and verbal communication
Candidates looking to be in a management role. Too much experience 10 YOE.

Interview process:

1:1 with hiring manager

1:2 or 1:3 with prospective team members

Remote video Interviews

Regards

3KC Talent Acquisition Team

Required Experience:

Senior IC

Job Title: Senior Device Engineer Electromechanical Combination Products (Lifecycle Management Design Control CAPA) - (JP15315)Location: Thousand Oaks CA. 91320Employment Type: ContractBusiness Unit: Electromechanical PlatformDuration: 1 year (with likely extensions and/or conversion to permanent)P...

Lifecycle Management Experience with electromechanical platforms
Root Cause Analysis and Technical Problem Solving
Proven success in cross-functional engagement and being a team player
Nice to have: Early device development experience

Day to Day Responsibilities:

Provide ongoing lifecycle management (LCM) support for electromechanical combination products including post-market activities design improvements and cross-functional issue resolution to ensure product reliability and compliance.
Lead complaint investigations by performing detailed failure analysis identifying root causes and developing data-driven action plans in collaboration with quality manufacturing and regulatory teams.
Drive and manage quality system processes including CAPAs deviations and change controls ensuring timely closure robust documentation and alignment with regulatory and internal requirements.
Collaborate closely with external suppliers to support LCM activities including issue resolution component updates root cause analysis CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
Manage change assessments driven by internal and external changes during the life cycle of the combination product
Participate in and support cross-functional design reviews for combination product development.
Provide design verification support for combination products ensuring compliance with Quality System Requirements Design Control (21 CFR 820.30) and ISO 13485.
Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
Develop review and execute test protocols reports and technical documentation in accordance with design control and regulatory expectations.
Perform data verification analysis and traceability reviews to ensure product performance meets user needs and design inputs.
Partner cross-functionally with R&D Human Factors Quality Regulatory and Manufacturing teams to drive design robustness risk mitigation and design transfer readiness.

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Preferred Qualifications:

- Masters or Bachelors Degree in Engineering Discipline (Mechanical Biomedical Electrical) with 3-5 years (or 2 years with Masters) of professional experience in highly regulated environment (strong preference for medical device biopharma and/or combination product experience).
- Experience with electromechanical systems injection devices medical devices or delivery platforms preferred.
- Demonstrated expertise in lifecycle management data analysis and protocol/report generation under design control.
- Strong understanding of materials coordination supplier interaction and lab testing logistics.
- Proven ability to work in cross-functional project teams communicate technical results clearly and lead execution to meet program milestones.
- Working proficiency in statistical analysis software (Minitab)
- Smartsheets proficiency is a plus.
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Must be capable of working on multiple projects in a deadline driven environment.
- The position is designed for candidates at a mid-career stage with scope and responsibilities aligned to that level of experience.

Red Flags:

Unable to be consistently on-site in Thousand Oaks
Low motivation/engagement at prospect of working with medical device and/or combination products
Poor written and verbal communication
Candidates looking to be in a management role. Too much experience 10 YOE.

Interview process: