Technical lead MDR, PFMEA

The Technical Lead will be responsible for leading the MDR, medical ISO
13485 process, Process Failure Mode Effect Analy(PFMEA) within the organization. They will oversee the technical aspects related to medical device reporting, ISO 13485 processes, and PFMEA.

The Complaint Handling Associate owns the intake, triage, and investigation coordination of product complaints across Neu Wave's device portfolio, ensuring that all complaints are logged, evaluated for regulatory reportability, investigated, and closed within the timelines required by applicable regulatory requirements. This role administers the eQMS Complaint Handling module — routing incoming complaints from Customer Service and Sales, initiating investigations, drafting complaint records, and supporting management review through periodic complaint trending.

The ideal candidate brings 4‑6 years of complaint handling or post‑market surveillance experience in the medical device industry, with working knowledge of FDA MDR requirements, EU MDR vigilance, and complaint investigation methodologies including root cause analysis. Hands‑on eQMS complaint module experience is strongly preferred, along with the ability to write clear, well documented complaint records that can withstand regulatory audit scrutiny.

Strong collaboration and communication skills are critical to this role. Please let us know if there are any team members who have this experience.

• Provide technical leadership and guidance on MDR and medical device regulations.
• Implement and maintain ISO 13485 processes to ensure compliance.
• Conduct process failure mode effect analysis (PFMEA) to identify and mitigate risks in processes.
• Collaborate with cross‑functional teams to drive continuous improvement in quality and regulatory processes.
• Develop and update standard operating procedures (SOPs) related to MDR, medical devices, and PFMEA.
• Train and mentor team members on technical aspects and best practices in medical device regulations.

• In‑depth understanding of MDR regulations and medical device reporting processes.
• Proficiency in implementing and managing ISO 13485 quality management systems.
• Experience in conducting PFMEA in a regulated industry.
• Strong analytical and problem‑solving skills.
• Excellent communication and interpersonal abilities to collaborate effectively with diverse teams.
• Attention to detail and strong organizational skills to ensure compliance and quality standards are met.

• Relevant certifications in medical device regulations, ISO 13485, or PFMEA are a plus.

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance‑based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program;

401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need‑based leave with no designated number of leave days per year); and 10 paid holidays per year.