Sr Medical Device Engineer

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.

Top 3 Must Have Skill Sets:

• 1. Lifecycle Management Experience with electromechanical platforms
• 2. Root Cause Analysis and Technical Problem Solving
• 3. Proven success in cross-functional engagement and being a team player

Nice to have:
Early device development experience

• • 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.

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.