Senior Developer

Job Description

The Senior Developer will be responsible for mdr,medical iso13485 process and Process Failure Mode Effect Analysis (PFMEA). The primary objective is to develop and implement software solutions in compliance with medical device regulations and quality standards. (1.) Key Responsibilities 1. Develop and maintain software applications in adherence to mdr,medical iso13485 process requirements 2. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in software development processes 3. Collaborate within team to ensure software solutions meet regulatory standards and quality expectations 4. Participate in audits and reviews to assess software development processes for compliance with industry regulations 5. Provide technical expertise and guidance on mdr,medical iso13485 process and pfmea best practices Skill Requirements 1. Proficiency in mdr,medical iso13485 process and quality management systems 2. Experience in conducting process failure mode effect analysis (pfmea) in software development projects 3. Strong knowledge of medical device regulations and standards 4. Good problem-solving skills and attention to detail 5. Ability to work effectively in a team environment and communicate complex technical concepts clearly 6. Familiarity with software development lifecycle and best practices Certifications: Certification in mdr,medical iso13485 process or PFMEA is a plus No. of Positions 3 Skill (Primary) Technical Skills (ERS)-SAP PLM - Configuration-Process Failure Mode Effect Analy(PFMEA) Auto req ID 1569124BR Skill Level 3 (Secondary Skill 1) Tools and Standards (ERS)-Standards - Medical-MDR Skill Level 3 (Secondary Skill 2) Tools and Standards (ERS)-HW Product Dev Process Standard-Medical - ISO13485 Process