Associate Engineer, Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416)

• The Associate Engineer will hold a STEM degree in Mechanical, Biomedical, Biotech, or a related field and bring about 1-2 years of internship or professional experience in mechanical design, automation, process engineering, and root cause analysis.
• This role requires strong documentation and report-writing skills alongside hands-on lab experience supporting clinical manufacturing and medical device tech transfers (e.g., syringes, auto-injectors).
• Candidates should be entry-level with the ability to learn and grow during a two-year assignment, comfortable investigating deviations, and capable of collaborating with engineering and vendor teams, with potential for future conversion based on performance.
• Master’s degree could be considered a plus.
• Open to non-traditional candidates if lab/instrument experience is applicable.

• Entry-level preferred (fresh grads or 1–2 years’ experience; internships valuable).
• Bachelor’s in STEM (Mechanical Engineering, Biomedical Engineering, Biotech, etc.).
• Experience in:

• Mechanical design, automation, software, process engineering.
• Root cause analysis (RCA).
• Documentation and report writing (large administrative/documentation component).

• Mechanical Design
• Automation Software
• Process Engineering

• Support Tech Transfer activities
• Lead process gap assessment exercises
• Generate PTD (Process Transfer Document)
• Manage dashboards by updating KPI status and timelines
• Support characterization and PPQ activities at the receiving site
• Perform forensic analysis of devices
• Conduct root cause analysis using standard methodologies
• Leverage automation skillset to access and analyze equipment data
• Program within statistical analysis software or data tools such as MATLAB
• Update and optimize equipment automation recipes for quality, rapid device assembly
• Support design of test fixtures and/or assembly tools for manufacturing
• Troubleshoot device and equipment failure

• Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
• Engineering or biotechnology background
• Enthusiasm for new technology (digital and mechanical)
• Continuous improvement mindset
• Clear communication and presentation skills

• Overqualification (too much experience, PhD, too many certifications – risk of attrition).
• Non-STEM degrees without relevant lab/engineering exposure.
• Frequent job hopping (multiple short stints ?6 months).
• Generic/AI-generated resumes lacking context.
• Unexplained long employment gaps (less critical for entry-level).

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