Quality Engineer

THE OPPORTUNITY:

Quality Engineer, Full Time THE COMPANY:

At Second Wave Systems, we have developed a novel noninvasive approach to treat rheumatoid arthritis and other chronic and acute inflammatory disorders. Our Second Wave MINI device uses proprietary ultrasound technology on a wearable, personalized stimulation platform, giving patients and their physicians a new option for treating multiple health conditions.

Second Wave consists of a diverse, multi-disciplinary team that is focused on bringing this new technology to patients with quality and speed. As a fast-growing startup, we move quickly and approach each day with both focus and flexibility. We expect new challenges, attack them with confidence and creativity, and find new opportunities within them. We each wear multiple hats and enjoy taking on new responsibilities and growing into new areas.

If you thrive in this type of environment, enjoy solving difficult technical problems, and want to have a meaningful impact on the development of a novel medical technology, then we look forward to speaking with you.

Second Wave Systems is seeking a hands-on Quality Engineer to support the development, verification, manufacturing, and continued improvement of our medical device products and Quality Management System.

The Quality Engineer will work closely with Product Development, Manufacturing, Regulatory, Clinical, and Operations to ensure that quality is built into our products and processes from development through production. This role will support design controls, risk management, verification and validation, process development, nonconformance management, CAPA, supplier quality, and continuous improvement activities.

This is an excellent opportunity for an engineer who wants broad exposure to the complete medical device product lifecycle. Because we are a small and growing organization, the successful candidate will have the opportunity to take ownership of important quality activities while working directly with experienced engineers, scientists, and company leadership.

The ideal candidate will be technically capable, highly organized, comfortable working independently, and willing to roll up their sleeves to solve problems. We are looking for someone who brings a "can-do" attitude and understands that quality engineering in a startup requires both attention to detail and the ability to move quickly.

• Support Quality Engineering activities throughout the product development lifecycle, including requirements development, design reviews, design verification, design validation, design transfer, and production release.
• Support implementation and maintenance of design controls in accordance with the company's Quality Management System.
• Review product requirements, specifications, drawings, test plans, test reports, and other technical documentation for quality and regulatory considerations.
• Participate in design reviews and provide quality input regarding product risks, requirements, verification, validation, manufacturability, and reliability.
• Support maintenance of Design History Files and other quality records associated with product development.
• Support product risk management activities in accordance with ISO 14971.
• Participate in hazard analyses, risk assessments, FMEA/DFMEA activities, and risk reviews. Help ensure identified risks are appropriately addressed through design controls, verification and validation, and manufacturing controls.
• Support updates to risk management documentation as products, processes, and intended uses evolve.

• Support development of manufacturing procedures, work instructions, inspection criteria, control plans, and other quality documentation.
• Support process validation and qualification activities.
• Identify opportunities to improve manufacturing processes, reduce variation, and prevent quality issues.
• Support supplier qualification and ongoing supplier quality activities.
• Assist with supplier evaluations, quality agreements, supplier corrective actions, and supplier performance monitoring.

• Support implementation, maintenance, and continuous improvement of the Second Wave Quality Management System.
• Help ensure company processes are effectively implemented and documented in accordance with applicable procedures and regulatory requirements.
• Support document control and change control activities.
• Participate in internal…