Position Overview
We are seeking a Process Development Engineer to support the development, transfer, optimization, and lifecycle management of manufacturing processes for medical device products across internal manufacturing sites and contract manufacturers.
This role partners closely with R&D, Manufacturing, Quality, and external partners to support successful technology transfers, process validation, standardization, and continuous improvement. Hands-on experience with compounding, mixing, and filling of aqueous solutions and/or gel-based products is preferred.
Key Responsibilities
- Develop, optimize, scale, and transfer manufacturing processes from R&D through commercial production, with a focus on aqueous solutions and gel-based products.
- Conduct feasibility studies, process characterization, Design of Experiments (DOE), and statistical analysis.
- Define critical process parameters, specifications, control strategies, and validation requirements.
- Support pilot builds, scale-up, commercialization, and new product introduction activities.
- Lead technology transfers to internal manufacturing sites and contract manufacturers, including documentation, risk assessments, training, validation, and initial production runs.
- Serve as a technical partner to contract manufacturers, supporting process changes, deviations, investigations, supplier qualification, and performance monitoring.
- Coordinate and support process qualification and validation activities, including IQ/OQ/PQ and cleaning validation.
- Standardize and harmonize manufacturing processes across sites and identify opportunities to improve process capability, yield, quality, and efficiency.
- Maintain processes in a validated state through monitoring, trending, statistical process control (SPC), and continuous verification.
- Lead root cause investigations and implement effective corrective and preventive actions.
- Ensure processes and documentation comply with applicable quality and regulatory requirements.
Qualifications
- Bachelor’s degree in Mechanical, Biomedical, Materials, or a related Engineering discipline.
- 3–5 years of product or process development experience, preferably within the medical device, pharmaceutical, or biotechnology industry.
- Hands-on experience with compounding, mixing, and filling of aqueous solutions and/or gel-based products is preferred.
- Experience with design verification, validation, and process qualification(IQ/OQ/PQ).
- Experience with cleaning validation in a regulated manufacturing environment.
- Working knowledge of FDA design controls, ISO 13485, and risk management practices such as ISO 14971 and FMEA.
- Proficiency with statistical and quality tools, including DOE, SPC, and root cause analysis.
- Experience with CAD software (such as SolidWorks), engineering drawings, and GD&T.
- Strong analytical, problem-solving, project management, and cross-functional communication skills.
- Ability to manage multiple projects and priorities in a collaborative environment.
- Fluency in English required.
Preferred Qualifications
- Six Sigma Green Belt or Black Belt certification.
- Experience with Design for Manufacturing (DFM), Design for Six Sigma (DFSS), NPI, and design transfer.
- Experience supporting regulatory submissions, including 510(k) and CE/MDR technical files.
- Experience with aseptic processing, sterile manufacturing, or cleanroom operations.
Work Environment
- Primarily office and manufacturing-site based, with occasional work in active construction or renovation areas requiring appropriate PPE.
- Up to 30% travel in DFW area.
- Primarily sedentary work with occasional lifting of up to 10 pounds and regular computer use.