Senior Device Engineer – Electromechanical Combination Products; Lifecycle Management, Design Control, CAPA JP

Senior Device Engineer – Electromechanical Combination Products

3 Key Consulting is hiring a Senior Device Engineer – Electromechanical Combination Products 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
• Early device development experience (nice to have)

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:

• Master's or Bachelor's 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