Design Quality Engineer

Location: Neuspera Medical, Inc. headquarters in San Jose, CA

Reporting to: Director of Quality

JOB SNAPSHOT

Base Pay - Negotiable

Employment Type - Full-Time

Job Type - Engineering

Education - 4 Year Degree

Experience - Minimum 3 years

Manages Others - No

Industry - Medical Devices

Required Travel - Occasional

ABOUT NEUSPERA MEDICAL, INC.

Neuspera Medical, Inc. is an exciting early-stage medical device company with a uniquely positioned neuromodulation technology platform, headquartered in San Jose, CA.

Neuspera is committed to developing implantable medical device technology that will improve the lives of patients battling chronic illness. With the first intended indication for use as Urinary Urgency Incontinence (UUI), the platform technology is ultimately designed to deliver targeted bioelectronic medicine for a variety of conditions. Neuspera’s minimally invasive implants with external wearable transmitters offer the possibility for therapies to reach deeper, harder to access anatomical locations in the body.

WHY NEUSPERA?

Take the next step in your career and join Neuspera today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of accountability, respect, tenacity, results, and integrity are embedded in everything we do. No matter what your role may be, Neuspera strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

PRIMARY FUNCTION

Quality Engineer supporting manufacturing operations and design transfer. Key areas of support include incoming and in-process inspection, MRB, quality systems, process validations and test method validation. This position is expected to take a hands-on approach on all aspects of quality engineering and quality systems.

JOB DUTIES

• Work with Manufacturing, R&D, Regulatory, and Clinical to meet clinical and commercial milestones
• Provide daily quality support to incoming inspection and manufacturing activities
• Review and monitor processes for Receiving and In-Process Inspection, Calibration / Preventive Maintenance, Nonconforming Materials, Product Testing, and Finished Goods Release
• Maintain quality system and participate in internal/external audits to ensure compliance with FDA regulations and ISO 13485
• Review investigations of device deficiencies/complaints
• Review changes in manufacturing processes and support process validation activities (IQ, OQ, PQ)
• Collaborate with engineers to evaluate and validate applicable test methods
• Lead MRB activities to investigate nonconformances and identify root cause and corrective actions
• Initiate changes to improve quality systems and processes
• Conducts supplier qualification and maintenance activities
• Evaluate quality performance data and present results to the management team
• Other responsibilities as assigned

JOB REQUIREMENTS

• Basic understanding of the medical device industry including 21 CFR Part 820 and ISO 13485
• Basic understanding of mechanical and/or electrical engineering
• Experience with sterilization and statistical analysis

QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in Engineering, Science or similar field
• Results driven, collaborative team player capable of working well with others, as well as autonomously with little direction
• Ability to adapt to dynamic situations and adjust as we grow
• Experience with software validations a plus

COMPENSATION

Based on market data and other factors, the salary range for this position is $100,000 - $125,000. However, a salary higher or lower than this range may be appropriate for a candidate whose qualifications differ meaningfully from those listed in the job description.

WORK ENVIRONMENT

• Office and laboratory
• Some travel necessary
• Foster work culture of; Diversity and inclusion, honesty and integrity, accountability and teamwork, proactive communication focused on results that is based on facts and is respectful