Job Summary:

Vena Medical is seeking a Staff Process Engineer to lead new product introduction (NPI) activities, focusing on scaling medical devices from R&D into manufacturing. The successful candidate will work in an ISO 13485–compliant environment to establish, validate, and optimize manufacturing processes, coordinate with contract manufacturers, and support design verification and validation activities. This role requires a hands-on engineer who can bridge product development and manufacturing, ensuring quality, compliance, and efficiency in the transition from prototype to production.

Responsibilities:

• Work in an ISO 13485–compliant environment to ensure adherence to medical device regulations and standards.
• Develop, validate, and improve processes to ensure consistent product performance and quality
• Communicate and collaborate with contract manufacturers on product, process, inventory and quality assurance based items
• Determine technical requirements and coordinate contractor operations, including purchasing and installing machinery and infrastructure (e.g., cleanroom installation, process equipment).
• Develop and optimize manufacturing processes for medical devices in an ISO 14644-1 certified cleanroom environment.
• Lead manufacturing planning and validation activities, including VMP, IQ/OQ/PQ, pFMEA, and monitoring plans.
• Perform risk assessments and maintain hazard analysis documentation in line with ISO 14971.
• Support the Quality Management System through clear, compliant documentation and recordkeeping.
• Support R&D activities through test method development, validation, and execution for optical and mechanical systems.
• Assist with design verification and validation activities, including test protocol development, execution, statistical analysis, and report generation.
• Engage in sourcing, evaluating, and onboarding manufacturing partners and suppliers.
• Support product manufacturing until fully transitioned to production.
• Maintain Design History Files, Device Master Records, and Device History Records as required.
• Provide technical training and support for manufacturing technicians and assemblers.
• Additional responsibilities as required in a fast-paced startup environment.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field).
• 3+ years of experience in medical device manufacturing, NPI, or process development; catheter, endoscope, optics or electronics assembly experience preferred.
• Strong understanding of FDA, QSR, and ISO 13485/ISO 14644 medical device regulations and standards.
• Demonstrated ability to transfer products from development into production.
• Experience leading manufacturing validation activities (VMP, IQ/OQ/PQ).
• Proficiency with statistical methods and tools (e.g., DOE, capability analysis, sampling plans, SPC) to analyze test data, plan and justify validation activities, and support data-driven decision making.
• Knowledge of risk management and hazard analysis (ISO 14971).
• CAD abilities, preferably SolidWorks.
• Familiarity with cleanroom manufacturing processes and environments.
• Hands-on experience with prototyping and process equipment (adhesive dispensers, lamination, tipping, assembly tools, etc.).
• Strong problem-solving skills and ability to work cross-functionally.
• High energy level, attention to detail, and entrepreneurial mindset.