Quality Engineer

Quality Engineer

SecondWave 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.

SecondWave Systems is revolutionizing treatment of inflammatory disease. The company is developing a first-of-its-kind noninvasive, wearable, and personalized ultrasound stimulation platform that will give patients and their physicians a new option for treating debilitating or life-threatening disease.

SecondWave 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.

General Description and Duties:

• 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 SecondWave 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 audits and support external and supplier audits.
• Assist with quality system training and implementation of new or revised procedures.
• Maintain accurate and complete quality records.
• Other duties as assigned

Requirements:

• Bachelor's degree in Engineering, Biomedical Engineering, Quality Engineering, or a related technical discipline.
• 5+ years of relevant experience, with progressively increasing responsibility in Quality Engineering, Design Quality, Manufacturing Quality, or a related engineering role.
• Medical device industry experience strongly preferred.
• Working knowledge of ISO 13485 and FDA Quality System Regulation/QMSR requirements.
• Working knowledge of ISO 14971 and medical device risk management principles.
• Experience with design controls, design verification/validation, change control, CAPA, nonconformance management, or related quality system activities.
• Experience with root cause analysis and structured problem-solving.
• Ability to read and understand engineering drawings, specifications, test documentation, and other technical documentation.
• Strong analytical, organizational, documentation, and communication skills.
• Ability to manage multiple priorities and work effectively in a fast-paced startup environment.
• Ability to work independently while knowing when to seek guidance or escalate an issue.
• Strong attention to detail and commitment to product quality and patient safety.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Preferred Qualifications:

• Experience with Class II or Class III medical devices.
• Experience with electromechanical or ultrasound-based medical devices.
• Experience supporting new product development and design transfer.
• Experience with DFMEA, PFMEA, fault tree analysis, or other risk analysis techniques.
• Experience with process validation and equipment qualification.
• Experience with statistical methods, statistical process control, or data analysis.
• Familiarity with IEC 60601 or other medical electrical equipment standards.
• Experience with supplier quality and supplier corrective actions.
• Experience with electronic Quality Management Systems.
• ASQ Certified Quality Engineer (CQE) or other quality certification.
• Lean or Six Sigma training/certification.

Physical Demands:

• The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may enable individuals with disabilities to perform the essential functions.
• The incumbent typically works in an office environment and uses a computer, telephone, and other office equipment as needed to perform duties. The noise level in the work environment is typical of that of an office.
• Incumbent may encounter frequent interruptions throughout the workday.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds.

Pay and Benefits:

Pay Range: $100,000-150,000 base salary; depending on qualifications/experience; Equity compensation to be provided

FLSA Status: Full-Time Exempt

SecondWave Systems offers a comprehensive benefits package that includes:

• Medical, dental, and vision insurance
• Short- and long-term disability insurance
• Employee Assistance Program
• Company paid and Voluntary Life insurance
• Aflac
• Paid company holidays
• Vacation and sick time
• SIMPLE IRA with 3% company match
• Opportunities for advancement